Regulatory Affairs Manager Resume Samples

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F Rowe

Francisco

Rowe

50502 Edmund Inlet

Los Angeles

+1 (555) 447 5581

50502 Edmund Inlet

Los Angeles

Phone

p +1 (555) 447 5581

Experience Experience

Houston, TX

Regulatory Affairs Manager

Houston, TX

Orn-Rohan

Houston, TX

Regulatory Affairs Manager

Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered
Raising of internal and external awareness of regulatory developments
Determining effective regulatory pathways for a variety of products types
Managing CMC activities for assigned products across the region
Assessing, approval and release of communication material (IFU, leaflets, brochures)
Registering/notification of Class I medical devices before they are marketed
Monitoring legislative environment in relevant markets

San Francisco, CA

Regulatory Affairs Manager, Cardic Assays

San Francisco, CA

Becker-Keeling

San Francisco, CA

Regulatory Affairs Manager, Cardic Assays

Actively contribute to the development and functioning of the crisis/issue management program
Manage and execute preapproval compliance activities
Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
Provide regulatory input for product recalls and recall communications
Provide regulatory input to product lifecycle planning
Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval

present

Phoenix, AZ

Senior Regulatory Affairs Manager

Phoenix, AZ

Raynor Inc

present

Phoenix, AZ

Senior Regulatory Affairs Manager

present

Recommends changes to labeling, manufacturing, marketing, and clinical and development protocols
Analytical – logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
Reviews product labeling/advertising to ensure compliance with federal regulations
To assist with marketing and generating new business
Provide continuing regulatory education and dissemination of RF regulatory information to the development, marketing and clinical groups
Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects
Independently map out filing and regulatory strategy

Education Education

Bachelor’s Degree in Pharmacy

Howard University

Bachelor’s Degree in Pharmacy

Skills Skills

Able to demonstrate professional knowledge within RA and PV & S
Strong knowledge of federal and international regulations, and quality systems in regulated manufacturing environment
Strong knowledge of device/product development and regulatory policy; excellent scientific and business judgment
Attention to detail, organizational skills, and a demonstrated ability to prioritize multiple projects. Excellent written and verbal communication skills
Ability to communicate conceptually detailed and complex information effectively and professionally with a wide range of people
Critical thinking ability and good judgement
Highly skilled in establishing partnerships with regional colleagues in a highly matrix environment
Strong attention to detail
A strong results-orientation and sense of urgency whilst demonstrating proficiency and success in prioritizing and handling multiple projects simultaneously
Accountable for regulatory strategy, deliverables, and results to support new product development both domestically and internationally

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15 Regulatory Affairs Manager resume templates

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Regulatory Affairs Manager Resume Examples & Samples

Oversee and execute the preparation of licensing, timeshare, and consumer finance filings and registrations
Develop and prepare initial resort inventory set-up so that sales may occur
Manage the process of registrations, renewals and amendments of DVC Resorts for sale with domestic and international regulatory agencies
Partner with Disney Legal Department and potentially external legal counsel to monitor, research, and determine the significance and impact of legislative changes to existing and future business policies and programs, ensuring full compliance across all DVC areas, including all sales, marketing and operations channels domestically and internationally
Recommend/draft legislative changes, including work with internal and external legal counsel, lobbyists, and industry associations
Minimum of four years legal/compliance and real estate experience or related fields
Demonstrated expertise in the areas of legal research and analysis
Demonstrated experience in auditing methods and contract management
Demonstrated critical thinking, creative, and problem solving skills, as well as continuous improvement process skills
Demonstrated strong leadership, coaching, and partnering skills
Demonstrated strong verbal and written communications as well as presentation skills
Proven Project Management experience

Regulatory Affairs Manager Resume Examples & Samples

Minimum Bachelor of Science or Bachelor of Arts with focus on biology, chemistry, biochemistry or toxicology
Minimum 5 -7 years regulatory management experience in the cosmetics /personal care industry
English – both written and verbal proficiency, other language(s) desirable

Regulatory Affairs Manager Resume Examples & Samples

Provide regulatory advice to support the LOC Business strategy
Ensure that Regulatory Compliance of products destined for the markets is achieved
Ensure that regulatory requirements in Spain and Portugal are fully represented in discussions at Global, Regional and Local levels
Liaise with Portuguese and Spanish Technical Directors to ensure alignment on regulatory activities in the cluster
Act as the key contact for all LOC stakeholders on local regulatory topics
Support and align with other dept/functions on needs re periodical requests from regulatory authorities (e.g., set up of registries, preparation of data in time to support market access)
Provide local support to the EU Regulatory strategists for local submission when necessary in case of specific contact to take with the agency or review of national requirements
With support of QA/Compliance may participate in drawing up and monitoring Company standard operating procedures, as well as checking on their application, in cooperation with superiors
Country R&D Council (CRDC) - As active member of the Spanish CRDC Provide integrated R&D strategic regulatory oversight to ensure: effective communication and alignment with the objectives of commercial colleagues in the development and execution of quality and timely LOC strategies, championing of external scientific face of Shire, regulatory national activities and compliance

Regulatory Affairs Manager Resume Examples & Samples

A minimum of three to five years’ experience in regulatory licensing, and/or blood bank compliance required
Prior publication in peer reviewed journal and public speaking experience is a plus
Thorough knowledge of regulatory processes and regulatory requirements
Ability to develop and advocate policy
Demonstrated ability to establish policies, guidelines, plans and priorities; ability to identify resources and coordinate with others; monitor progress, evaluate outcomes and improve organizational efficiency and effectiveness
Demonstrated technical proficiency and understanding of its impact in area(s) of responsibility
Demonstrated ability to analyze, synthesize, evaluate, formulate, and implement decisions; take action and risks as needed; make difficult decisions when necessary and make sound decisions
Proven ability to foster teamwork, cooperation, consensus, and facilitation of open communication
Demonstrated leadership ability of encouraging high standards of behavior and ability to delegate responsibility, adapt leadership style to situations and people, and empower, motivate, and guide others
Demonstrated fiscal responsibility through effective budgetary management and understanding of department budget’s impact on the overall financial picture of the organization
Demonstrated ability to hold self and other accountable for following procedures, guidelines, and policies and addressing performance and behavior issues in a timely manner
Working knowledge of Microsoft Office programs, including Excel, Word, PowerPoint, Outlook and other programs and databases as needed

Regulatory Affairs Manager Resume Examples & Samples

5+ years of experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch
Demonstrated success in a managerial capacity
Demonstrated strategic development capabilities related to new drug development and commercial support activities

Regulatory Affairs Manager Resume Examples & Samples

5+ years of Biopharmaceutical experience with emphasis in Regulatory Affairs and Drug Development
Bachelor's Degree in a Scientific, Healthcare or related field or equivalent experience
Knowledge of FDA regulations and guidelines on Drug Development and the approval process for NDA/BLA and post-marketing supplements

Regulatory Affairs Manager Resume Examples & Samples

Oversee all regulatory activities and projects within defined time schedules and in accordance with internal procedures, agreed deadlines and legislative requirements
Manage and lead assigned regulatory projects including management of budget, time-lines and submission planning
Proactively communicate regulatory strategy, key issues and any other critical topics to Managing Director
Take the lead in health authorities interaction and relationship building
Supporting pharmacovigilance activities, EVMPD, Medical Information, clinical and non-clinical work (include s writing / review of clinical overview and clinical summary documents)
Management of training and mentoring of junior regulatory employees to ensure they are competent and confident in providing service excellence within the sector
Identify opportunities for business development based on a comprehensive knowledge of the sector
Continuously assess regulatory framework to ensure that the company is providing the most up to date and relevant service to clients
B.Sc. Minimum or pharmacy primary degree
A minimum of 7-10 years experience of cross-functional Regulatory Affairs in the Pharmaceutical Industry. In addition to pharmaceutical sector experience, pharmacovigilance and or medical devices would be a distinct advantage
Excellent project management skills with the ability to oversee multiple projects simultaneously
A proactive approach with the ability and experience to manage a diverse team of professionals
A proven track record in communicating with top level management and competent authorities
Solid understanding and experience of electronic Common Technical Document eCTD submissions
Strategic thinking as well as hands-on experience with different registration procedures
Demonstrate professionalism and leadership at all times

GCS & Regulatory Affairs Manager Resume Examples & Samples

Intellectual and analytical skills of a high order. He/she is likely to be a graduate and / or have a professional qualification
The strength of character, credibility and personal presence and the communication skills to operate confidently and effectively at senior levels both internally and externally
The flexibility to appreciate the commercial objectives of the business, coupled with an ability to challenge, independently and constructively, senior management, peers or other staff where appropriate, to insist upon adherence to the highest standards of business practice and to the requirements of relevant authorities. Tact and sensitivity as well as strength and authority are important
Ability to use initiative and work with minimum supervision but ensuring, at the same time, that the line reports are kept fully informed at all times
Ability to consider issues from a range of angles and propose creative solutions that assist the business in achieving its goals in a safe, compliant and controlled manner
Ability to communicate effectively, orally and in writing, with senior internal and external audiences – to educate, persuade, negotiate, gain decisions, enforce
Ability to influence senior management
Ability to make a real contribution in a rapidly changing environment and thrive on change and the need to learn rapidly

Regulatory Affairs Manager Resume Examples & Samples

University degree and preferably with a Public Affairs/Public Relations/Legal/Political or Economic Science post graduate qualification
Minimum of 5 years experience working within corporate/public affairs
Excellent planning, organizational and administration skills
High standards of accuracy and attention to detail in all aspects of work
Keen commercial & financial awareness

Regulatory Affairs Manager Resume Examples & Samples

Assist SBL, Government Relations, China, in the development and implementation of China GR strategy to achieve agreed business objectives
Assist in communicating with lawmakers that supports business objectives and enhances Visa's reputation
Assist in promoting governments’, politicians’, and regulators’ understanding of Visa’s role and value resulting in a minimization of regulatory barriers to industry expansion
Monitor the regulatory and legislative landscape for threats and opportunities to Visa's business in China and communicate this intelligence to locally-based and functional colleagues and global leadership
Assist in identifying legislative, regulatory, and political threats to, or opportunities for, the local franchise
Be acutely aware of potential global implications of local issues and coordinate their management with global colleagues
Monitor global events and regulatory/legislative developments in other key markets to identify possible impacts on the local political landscape
Assist in the management of Visa's relationships with Chinese policy officials ensuring education of these officials about the value of Visa
Assist in coordinating regular direct contact with appropriate level of policy officials and staff
Assist in coordinating adequate and ongoing country manager contact with key policy officials and regulators
Assist in the development and delivery of informative and engaging local communications about the value of Visa fully aligned with business priorities and global messaging
Manage development and logistics of thought leadership events, such as conferences, roundtables, symposiums and similar events and activities
Coordinate regular face-to-face technical issue briefings between business SMEs (local, group, and global) with government officials
Assist in the management of Visa's relationships with external consultants, key industry associations, and other third-party advocates
Assist in the recommendation, engagement and management of Visa's relationships with necessary third-party intermediaries including government relations consultants, industry associations, and broad based business trade associations
Assist to establish and maintain appropriate contact with counterparts at other industry participants
The successful candidate will have a minimum of 2-5 years government relations experience and achievement. There is a strong preference for a combination of corporate and central/provincial government experience
Experience in public advocacy
A thorough knowledge of China Government and how it operates
An undergraduate degree is required. A graduate degree in related functions is preferred
Must demonstrate a strong understanding of core political and public policy motivators forChinese officials and other stakeholders
Exercise good judgment regarding confidential or material, non-public information
The ability to operate effectively and efficiently in a challenging, fast-paced environment with little supervision
Ability to manage substance and logistics for conferences, roundtables, symposiums and similar events and activities
Exercise good judgment in setting priorities and interacting with internal and external stakeholders
Strong ability to work collaboratively with others across geographic boundaries
Must be proactive and solution oriented, looking for ways to add value and assist the team
Language – Mandarin and English

Regulatory Affairs Manager Resume Examples & Samples

Provide input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site
Manage and maintain regulatory strategies, tools, timelines and dashboards
Coordination of meetings with Global and Regional teams to discuss strategies and resolve issues
Interfaces with the site (R&D and Operations authors)to ensure regulatory strategies are integrated into site projects
Support the preparation of regulatory filings, as needed
Identification of issues and factors that may implicate a regulatory strategy or activity
As assigned, responsible for the strategy and execution of the site specific aspects of the preparation of CMC amendments and post market supplements
Participation in Technical Transfer Teams, Global Regulatory Teams as required

Regulatory Affairs Manager Resume Examples & Samples

3-5 years of research experience
3-5 years working working with FDA and ICH/GCP guidelines
Experience with clinical research clinical trial management systems, electronic regulatory document submission systems, and electronic trial master file systems

Regulatory Affairs Manager Resume Examples & Samples

Be pro-active, prioritise and able to work with minimal supervision
High cultural awareness and sensitivity
Effective communication skills in order to present effectively, both verbally and in writing, scientific and strategic concepts
Critical thinking ability and good judgement

Watson Health Regulatory Affairs Manager Resume Examples & Samples

Bachelor’s degree in engineering or science discipline
Mastered regulatory compliance awareness, including at a minimum FDA design controls CFR 820, ISO 14971, ISO 13485, IEC62304, IEC82304 and working knowledge of HIPAA and GxP privacy and security controls
Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity
Experience in reliability characterization and demonstration test methods, including establishing relevant test parameters and test sample sizes
Proven experience as a leader of a team to take medical devices from concept to regulatory approval
Ability to learn quickly and respond to changing priorities
Good verbal and written communication skills, good team skills including project management
Maintains current knowledge of applicable federal regulatory laws and accreditation standards, and monitors advancements in information privacy technologies to ensure organizational adaptation and compliance

Regulatory Affairs Manager Resume Examples & Samples

Advises and supports the executive, functional and operational managers and their teams with regards to products regulations
Provides a proactive regulatory survey: collection and dissemination of information, release the internal regulatory newsletter regularly to provide latest regulation news and suggestions related to the group activities or businesses
Lead the registration process for all Bakery products and ingredient (including products produced in China, traded and imported to China), be the project interface between external and internal people, particularly for cross functional projects
Develops an expertise mainly in the field of food and feed regulations related to yeast and yeast products in the region: i.e. food ingredients, food additives, flavoring agents, dietary food supplement, food contact materials, contaminants, biotechnology, labeling…some support will also be required in pharmaceuticals, cosmetics, renewable chemicals and bio-pesticides, … with the support of internal experts or external consultants
Contributes to the promotion and defense of the Group's interests, through contacts with professional associations and Authorities: coordination with the group Regulatory Affairs and RA coordinators in other BU, implementation of the Group's regulatory strategy, anticipation and impact assessment of future regulations

Regulatory Affairs Manager Resume Examples & Samples

Bachelor's Degree in chemistry, biology or other related scientific discipline
5-7+ years in the pharmaceutical industry with at least 5-6 years of Regulatory experience supporting US FDA pharmaceutical products
Excellent understanding of regulatory requirements for ANDAs and 505b(2) applications
Proficiency in eCTD Publishing Software
Good knowledge of FDA guidelines, ICH and related guidelines
Proficiency in Microsoft office and XML programs
Previous R&D (analytical or formulation) experience
505b (2) experience

Scientific & Regulatory Affairs Manager Resume Examples & Samples

Cross-discipline collaboration and teamwork: Ability to establish and nurture productive cross-functional stakeholder collaborations, to apply understanding of scientific & regulatory processes including internal and external relationships to advance company’s and technical organization’s priorities
Build Value Based Relationships: Ability to generate alliances and value based relationship internally and externally
Regulatory Landscape: Familiar with the regulatory and political landscape (e.g., regulations, issues) affecting food and beverages industry in Australia, New Zealand and Pacific Islands
Advanced Regulatory Affairs: Ability to interact with government officials to represent the Company or beverage industry while explaining complex scientific data, reports or issues. This includes the ability to anticipate issues or concerns of interest to public health officials in order to respond to those concerns and the ability to advocate a position in a non-adversarial manner (e.g., during dispute resolution)
Advanced Policy Advocacy: Ability to engage, strategize, collaborate, and lead (both internally and externally) food and beverage policy initiatives that have the potential to negatively or positively impact the Company
Compliance: Advanced knowledge of SRA related compliance type process related to ingredients, products, packaging, claims and communication
Food Safety/Toxicology: Basic understanding of the nature, properties, effects, and detection of toxic substances in food, and their disease manifestation particularly chemicals of food interest such as food additives and pesticides, and how they are tested and regulated
Nutrition Science: Understanding of nutrition science including how dietary patterns influence health and well-being, biological mechanisms through which nutrients affect metabolism, dietary patterns, activity levels and related medical conditions particularly obesity and NCDs
10 or more years of experience in food industry, government or related industry in similar roles
Leadership roles in related external organizations/committees/boards
Master’s degree in food science, nutrition or related field. PhD a plus

Regulatory Affairs Manager Resume Examples & Samples

Main regulatory point of contact with national regulatory authorities on behalf of GE Healthcare
Responsible Person for the wholesaler license (GDP)
Local Pharmacovigilance person supporting central PV
Responsible for ensuring local regulatory compliance and maintenance for GE Healthcare products
Responsible person for the review and approval of promotional material in local market
Responsible for providing regulatory support to commercial business priorities
Responsible for preparing, maintaining and reviewing local Quality Management System including training and internal audit locally in accordance with GxP and local SOPs
Comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this position
Complete Quality & Compliance training within the defined deadlines
Proactive in assessing impact of new regulations in local market
Provide national regulatory support as requested in relation to authority inspections
Provide national regulatory input and approval related to Change Control processes for artwork
Bachelor’s Degree, preferably within pharmaceutical sciences, and minimum significant years of regulatory affairs experience from the medical device or pharmaceutical industry or with medical product regulatory agencies, with experience in dealing directly with regulatory authorities
Ability to prioritize, plan and evaluate deliverables
Ability to work independently with minimal daily supervision on projects and activities
Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner
Ability to interact with, lead and work with multiple functions/stakeholders
Team and business oriented – collaborate with others to solve business problems
Clear thinker and flexible
Strong PC-skills

Scientific & Regulatory Affairs Manager Resume Examples & Samples

Contribute to developing and executing SRA strategy for personal care and cosmetics
Actively facilitate the regulatory validation of (new) concepts and product ideas
Provide product information to internal and external customers with respect to regulatory requirements and communication activities
Develop appropriate policies, procedures and processes to ensure compliance and documentation in scientific and regulatory topics
Ensure awareness and expert understanding on emerging Personal Care/ Cosmetics regulations in the EMEA and NA regions and keep abreast of changes in the regulatory environment
Contribute to developing and communicating Cargill positions on regulatory and emerging issues
Monitor and influence external scientific and policy developments and communicate potential impact to businesses
Establish a functional network of external resources in the regions to support the ingredient portfolio and innovation pipeline
Travel up to 30% (domestic and internationally) of working time
MSc in Chemistry, Biology or Biological Engineering, Pharmacy or related scientific discipline
Minimum 5 years’ experience in Scientific and Regulatory Affairs in the Personal Care/Cosmetics sector in the EU region
Experience in Scientific and Regulatory Affairs in US desired
Knowledge of Scientific and Regulatory Affairs in other regions is a plus
Ability to work effectively both independently and as part of cross-functional teams
Fluent in English (strong written and oral communication skills), French is an asset

Regulatory Affairs Manager Resume Examples & Samples

Identifies plans, develops and applies regulatory strategies that permit the successful pre-market submissions of products worldwide
Identifies, develops, and implements innovative processes that promote efficiency for worldwide registrations
Reviews and analyzes ECOS, NCRs, manufacturing changes, clinical, design, and manufacturing protocols and documents
Organize project teams, initiates project schedule documentation and provides project leadership on a worldwide basis in order to achieve desired outcomes within timeframes defined
Participate and provide regulatory guidance and support to senior management and cross-functional teams
The position will require interaction with the US.FDA, and to other regulatory authorities around the word
This position will include participation on New Product Development (NPD) teams to provide regulatory guidance and to obtain rapid and timely approval of new products
Review and analyze technical data generated by Research and Development, Marketing/Sales, Clinical Research, Quality Assurance and other related departments
Evaluate changes in regulatory environment and standard. Conduct gap analysis and implementation plans to assure compliance to latest requirements

Associate Regulatory Affairs Manager Resume Examples & Samples

Tertiary qualifications in a science/health related field (additional qualifications such as a PhD or Masters in a related field would be highly regarded)
Extremely strong ethical values, working in a manner that aligns with the J&J Credo; and
A demonstrated ability to lead from the front, connect with key internal and external stakeholders, shape outcomes and deliver results

Regulatory Affairs Manager Cmc-regional Cluster Resume Examples & Samples

Partner with R&D, QA, Operations, Business Units and others to develop regulatory strategies for submissions and product related activities
Identify the required documentation for CMC submissions and negotiate the delivery of approved technical source data and documents in accordance with project timelines
Write high-quality CMC documents during development and product registration, contribute to CMC regulatory strategies, assure technical congruency and regulatory compliance by meeting agreed submission deadlines
Under direction of supervisor, interact with regulatory agencies as needed to respond to questions
Preparation, review, submission, approval and maintenance of CMC sections for regulatory filings (CTA’s, MAA’s, variations, renewals, etc.)
Review post-approval changes (change controls) and assess the regulatory impact on affected registrations. Develop regulatory strategies and coordinate filings (e.g. NDA supplements, Variations, Responses to Questions), as appropriate
Work collaboratively with global CMC colleagues and, as required, provide leadership to and supervision of CMC support colleagues
Work with R&D leaders to refine/develop processes relating to regulatory submissions and regulatory aspects of product development and maintenance
Train and educate colleagues with respect to regulatory requirements
Assess compliance of product (formulations, manufacturing processes, packaging, specifications, etc.) with filings and propose CMC mitigation strategies
Keep knowledge up to date with regard to quality guidelines and technical trends
Represent company in industry organizations, seminars, workshops, etc
Minimum B.S. Chemistry, Pharmacy or related scientific field
Working knowledge of regulatory requirements, particularly for EU and other EMEA countries, for various drug dosage forms including solids, semi-solids, solutions, sterile products, etc. Experience of requirements for other global regions is also beneficial
Comprehensive experience in preparation and maintenance of CMC sections for Health Authority filings (Modules 2 and 3, CTD, e-CTD); experience with global dossiers. Other relevant industry experience desirable
Awareness of consumer product categories (e.g., drugs, cosmetics, devices)
Experience with documents needed to support local, regional and global filing requirements
Technical/science-based background (QA, manufacturing, laboratory, plant, etc.)
Strong knowledge of GMP and regulatory compliance
Good interpersonal and written skills

Regulatory Affairs Manager Resume Examples & Samples

Active Substance Master File, Drug Master File, Certificate of Suitability (CEP) Submissions: Coordination and preparation for new submissions, regular updates, variations, renewals
Customer communication (prior and after submission of regulatory filings and/or filing updates filing)
Collaboration with customers to develop and align regulatory filing strategies and implementation plans
Sunrise project: Regulatory actions, e.g. customer communication, filing renewals, filing transfers, filing withdrawals
Coordination and preparation of responses to deficiency letters or authority requests
Coordination and preparation of responses of customer requests related to filings and or other regulatory/technical questions or questionnaires
Preparation and submission of Open Parts, Letter of Access, TSE Statement, Kosher/Halal Statement, Allergens Statement, Melamin free Statement, Latex free Statement, etc.)
Regulatory assessments of Change Requests and development of regulatory implementation plan
Regulatory assessment of major Non Conformances
Regulatory consultation for Quality Assurance, Production, Quality Control, Sales, Purchasing
Preparation of FDA-GDUFA (Generic Drug User Fee Amendments) applications
Regulatory support for inspections and audits
Ensure regulatory filing compliance and continued lifecycle management
Partner with Global Regulatory groups to coordinate and ensure submission of filings for US and/or other countries and/or regulatory activities for Janssen Supply Chain (JSC) products manufactured in Schaffhausen
Partner with Production, Chemical and Analytical Development, Quality Control, Quality Assurance and other departments as needed

Associate Regulatory Affairs Manager Resume Examples & Samples

Organizes and prepares registration documentation and related filings to regulatory agencies under planned approval timeline
Coordinate with internal cross-functionally team, third party manufacturers and designated distributors to ensure the compliance checks for any changes and variation which may be occurred for OTC drugs under J&J Thailand and to ensure on-time delivery of registration documents to the request of health agencies or export country customers
Review labeling and advertising claims for compliance to local regulations
Proceed the approval of drug advertisement approval
Determine and update regulatory requirements and relevant government regulations. Stay current on regulatory developments and trends in the industry that could affect J&J Consumer product line
Representing and networking with external parties such as associations and update the regulatory trends and new regulations that may impact the business
Learning, understanding and implementing company SOPs and Best Practices for ensuring compliance according to regulatory and quality policy of the company
Update registration information and registration status in company database
Execute the submission of FDA reports according to FDA requirements
Verify and approve for raw materials and finished product release approval
Bachelor’s Degree in Pharmacy
Minimum 1-2 years’ experience in drug registration approval with Thai FDA
Knowledge of FDA regulations and standards
Core competencies required for this role
Good interpersonal and effective communication skills
Analytical, attention to detail and problem-solving skills
Good command in spoken and written EnglishRegulatory Affairs

Regulatory Affairs Manager Resume Examples & Samples

Management of the RA Department
Obtain and maintain marketing authorizations – define and implement the registration for new products and maintenance of products on the market
Participate and contribute to the country business discussions
Ensure fast introduction of new products and line extensions, including new indications
Maintain and support communications with Health Authorities and third parties
Ensure regulatory compliance
Streamline regulatory activities with other business partners
Influence the regulatory environment

Regulatory Affairs Manager Resume Examples & Samples

Appropriate Regulatory Affairs experience with minimum of 6-10 years spent within a pharmaceutical or consumer health or personal care company
An extensive knowledge of pharmaceutical and/or consumer products technology
Full command of English language. Knowing any Asia language or having working experience in Asia Countries is a plus
Ability to communicate clearly verbally and in writing.Regulatory Affairs

Regulatory Affairs Manager Resume Examples & Samples

Independently authors, develops, complies, reviews, maintains and files high-quality excipient and API Common Technical Document (CTD) and Drug Master Files (DMF’s) with regulators (FDA, EMA etc.). Completes Annual Reports and other required FDA filings to ensure high-quality submissions and expeditious approvals from FDA. Reviews country specific regulatory requirements to support marketing strategy. Applies for FDA “Certificate of Pharmaceutical Product - CPP” – sales/customer support
Monitor regulatory developments in pharma area, and work with plants to roll out new FDA and IPEC requirements
Work with sites and R&I to support implementation of appropriate pharma API and excipient GMP’s at Novecare sites and during product development
Prepare excipient information packs to support customer regulatory information requirements. Responds to customer Excipient and API regulatory requests
Apply for, maintain, and renew US state registrations for fertilizer products and new bio-stimulant offerings
Support fertilizer and biostimulant registration work in Canada
Participate in EPA FIFRA Trade name database submission work and organic materials (OMRI) submissions, maintaining high quality information
Assesses changes and their impact to the business based on an advanced understanding of regulatory guidelines and applicable federal laws
Assists in the formulating sound strategies in support of submission goals
Represents regulatory affairs in project team meetings and provides regulatory guidance and perspective to team members in determining appropriate actions in order to meet scheduling timelines and/or in resolving technical issues
Minimum of a Bachelor’s Degree in chemistry or Chemical Engineering. Master’s degree preferred
Minimum of 5 years in the pharmaceutical industry with 3-4 of those years in regulatory affairs
Demonstrates in-depth knowledge and understanding of FDA guidelines with proven ability to successfully apply these to work output
Performs duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA
Strong critical and logical thinker with ability to analyze problems and recommend solutions
Effectively communicates regulatory requirements and strategies as they affect regulatory submissions to internal and external partners
Exercises sound judgment. Demonstrates an advanced ability to make appropriate decisions on regulatory activities and work outputs
Effectively prioritizes competing tasks in a fast-paced and dynamic environment
Highly motivated, results driven with unyielding predisposition to detail, accuracy and clarity
LI-EP1

Regulatory Affairs Manager Resume Examples & Samples

Bachelor’s degree in Government Relations, Political Science, or a related field
Minimum of three (3) years’ experience in and knowledge of regulatory affairs
Knowledge of federal legislative and executive branch procedures and policies
Knowledge of relevant health issues
Prior experience writing regulatory comment letters
Ability to identify issues and opportunities in the legislative environment that will help further the mission of the American Heart Association
Excellent writing and oral communication skills and the ability to think analytically
Ability to operate with minimum supervision, take initiative, and produce results
Master’s degree in Public Policy, Pubic Administration, Political Science or related field desirable
Experience working within a federal agency such as CMS or HHS

Scientific & Regulatory Affairs Manager Resume Examples & Samples

Minimum Bachelor Degree preferably degree in Pharmacy / Chemistry / Biology / Toxicology or Professional degree in Pharmacy (Pharmacist)
Minimum 9 years of working experience in Scientific Affairs / Regulatory Affairs / Business Development of Cosmetic / FMCG /Pharmaceutical
Good verbal and written communication skills (EN & IND)
Rigorous and precise work
Team player with strong engagement skills
Project management skills with customer service orientation skills
Proactive, take initiative, analytical thinking, get results by convincing and perform thorough investigations
Computer skills (Microsoft Office), including database management

Regulatory Affairs Manager Resume Examples & Samples

Supporting all regulatory activities associated with the development, post-approval and life-cycle management for designated products within the Oncology portfolio
Providing regulatory content support for products by interacting with project teams, LOCs and regulatory agencies (as appropriate) and supporting submissions as appropriate
Providing guidance and support to product development teams on regulatory issues
Contributing to the definition and development of new processes, standards or operational plans in support of the organizational/ business strategies, with a direct impact on business unit/function overall results
Excellent relationship building skills with the ability to communicate at all levels
Knowledge of how Health Authorities operates and a good general knowledge of HA organizational structure and individual responsibilities in those structures
Passionate about doing what’s right

Regulatory Affairs Manager Resume Examples & Samples

Master with a technical or scientific background
Minimum 3 to 5 years experience in regulatory affairs within the Medical Device Industry, preferably Software
You have knowledge of medical device legislation EU ,US, AUS and CAN and corresponding guidelines
You have good knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820
You have good knowledge of software development requirements (IEC 62304 and IEC 62366) as well as standards for electrical products such as IEC 60601
You have experience in preparation for notified body audits and FDA inspections
You are highly organized and able to work under strict timelines
You have strong interpersonal skills and proactive working attitude in a international matrix organisation
Excellent communication skills in English (written/oral), further languages are an advantage

Regulatory Affairs Manager Implant Systems Resume Examples & Samples

Creation, review and/or approval of documents of the design control process
Review and approval of product related labeling and marketing material
Minimum 3 to 5 years experience in regulatory affairs within the Medical Device Industry
Experience with EU, US, AUS and CAN medical Device regulations
Experience in managing cross functional projects and teams
Good knowledge of medical device legislation EU ,US, AUS and CAN and corresponding guidelines
Good knowledge of product development processes in MD industry
Good knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820
Fluent in English (verbal & written), further languages are an advantage
Strong interpersonal skills and proactive working attitude in a international matrix organization

Regulatory Affairs Manager Resume Examples & Samples

Developing and executing regulatory strategies for assigned projects while focusing on the main markets, i.e. EU, US, CAN and AUS. This will include the creation, review and/or approval of documents of the design control process, development of the technical file and summary of technical documentation
The incumbent will be responsible for CE marking and supporting the US submission and monitoring submission timelines and timely responses to requests by notified bodies or competent authorities. It also includes constant development/ improvement of product development and RA processes
Monitoring of legislative environment in main markets, i.e. EU, US, CAN and AUS and define and maintain an overview of the regulatory requirements and changes in the areas if applicable
Assessing, approval and release of communication material (IFU, leaflets, brochures)
Train and assist other departments to ensure continued compliance and timely market release
Development and execution of regulatory strategies for assigned development projects
Support of product development in cross functional teams
Accountable for regulatory compliance
Support international product registration
Assessment, approval and regulatory implementation of change requests
Support SAP based reporting systems
Monitoring legislative environment in relevant markets
Minimum 3-5 years experience in regulatory affairs within the Medical Device Industry
Bachelors Degree (BS); Masters Degree (MS) is an advantage
Strong knowledge of medical device legislation US, EU, AUS and CAN and corresponding guidelines
Strong knowledge of quality system requirements specifcially ISO 13485 and FDA’s 21 CFR Part 820
Documented working knowledge of product development processes in medical device industry
Experience in preparation for and participation in notified body audits and FDA inspections

Senior Regulatory Affairs Manager International Resume Examples & Samples

Interact with the RA teams in country
Demonstrate the ability to develop a variety of solutions to regulatory challenges
Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
Ensure schedules and performance requirements are met. Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities
Requires a minimum of ten years’ experience in Regulatory Affairs. Medical device experience in other areas, may be considered
Experience in supporting and maintaining international product approvals required
Demonstrated competence in determination of appropriate global regulatory requirements for new products or product changes
Demonstrated competence in project management skills
Experience in review and approval of promotional materials is a plus

Senior Regulatory Affairs Manager Resume Examples & Samples

5+ years’ Regulatory experience and 3+ years' people management experience.in a medical device environment
3+ year experience interfacing with regulatory agencies
Working knowledge of global medical device regulations, including submissions
Demonstrated writing/technical writing skills

Regulatory Affairs Manager Resume Examples & Samples

Experience at formulating successful regulatory strategies that meet aggressive preparation and approval timelines, while maintaining the highest level of quality and compliance
Demonstrated advanced software skills including Microsoft Word, excel, database (i.e. RAD/Documentum) and Adobe software skills
Ability to be flexible with changing priorities
Submission-related word processing skills
Ability to travel approximately 20%
1+ year experience interfacing with regulatory agencies

Regulatory Affairs Manager Resume Examples & Samples

Bachelor's degree required. Scientific or engineering field preferred
5+ years of medical device regulatory affairs experience
Must have authored 510(k) submissions
Must have knowledge of U.S. FDA regulations and standards
3+ years experience interacting with FDA and/or other regulatory agencies
Experience with devices containing software is strongly preferred
Must work well in team environments
Must demonstrate leadership skills in team setting
Proven analytical abilities
Solid understanding of manufacturing and change control, and an awareness of regulatory trends

Senior Regulatory Affairs Manager Resume Examples & Samples

Leadership capability
Highly motivated and results-oriented leader
Proven expertise in all aspects of Regulatory Affairs; Strategy Planning, Submission Prep, All Phases of FDA Device Law/Regulations, Global Regulatory Requirements/Procedures, Project Management, Negotiations, Medtronic Product/Design/ Development Systems
Proficiency in FDA compliance
Excellent written and verbal communication, technical writing, and editing skills
Excellent Project-management skills and experience

Regulatory Affairs Manager Latin Resume Examples & Samples

Knowledge and experience in Latin America registrations or one or more essential regulatory areas and marketing approvals; change assessment; advertising and promotional labeling; and quality systems
Knowledge of, and ability to interpret, applicable in-country regulations
General understanding of project management processes
Excellent written and verbal communication skills and computer literacy
Orientation to teamwork, problem solving ability, customer focus, and a commitment to quality

Regulatory Affairs Manager Resume Examples & Samples

Degree educated or equivalent
Scientific, Engineering or Law background preferable (but not essential)
Minimum 3 years experience in Medical Device Regulatory Affairs
Knowledge of the Medical Devices Directive and associated local laws
Knowledge of Quality Management System Standards preferred e.g. ISO9001, ISO13485
Experience of interaction with Competent Authorities / Notified Bodies
At least one Scandinavian language, preferably Swedish or Danish
Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems
Excellent attention to detail and high degree of accuracy when analysing and compiling documentation / data
Able to handle multiple projects and exercise good judgment in prioritising tasks
Able to work to strict deadlines and under pressure
Ability to network, negotiate and influence
Teamwork capability
Ability to positively contribute in supporting and developing a pan European Professional Team

Regulatory Affairs Manager Regulatory Lead Resume Examples & Samples

Based in the assigned region with interaction primarily on the GRT
A regional group leader
Executing the approved regional strategy for assigned programs
Advising the GRT on regional considerations in developing strategy
Knowledge of national legislation and regulations relating to medicinal products
Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals

Senior Regulatory Affairs Manager, Latin Resume Examples & Samples

Independently manages complex technical documents for preparation, review and submission to Latin American regulatory agencies. Prepares market authorizations and responses to questions from regulatory agencies in collaboration with other companies such as contract manufacturers/organizations, other Astellas subsidiaries, and Astellas Japan. Prepares and/or reviews summary tables of data from research and manufacturing reports, without direct supervision
Develops approach for new assignments having less-defined regulatory frameworks with management oversight
Regularly interacts with senior management in Regulatory Affairs and APLA/AFB within areas of responsibility
Member of important Astellas project teams/task forces requiring the interpretation of regulations/guidelines in areas pertaining to international submissions, with emphasis on CMC. Is considered a regulatory expert by the project teams/task forces and is accountable for recommending regulatory strategy
Independently determines the best ways to present information in assigned regulatory submissions to optimize their reviewability by the Health Authority. Evaluates, reviews and provides feedback on the CMC submissions from Japan
Actively seeks out knowledge of overall corporate strategy and other general factors that affect the regulatory positions taken within the company, and with the Health Authority, and incorporates this knowledge in interactions with others, both within Astellas and with the Health Authority. Will also impact corporate strategy directly via participation on project teams, or via recommendations for his/her projects to supervisor
Assists with Astellas ongoing training of Regulatory Affairs staff. Recognized as a person to whom others within the organization can consult to obtain answers to complex questions regarding international regulations and guidelines
Works closely with other individuals/groups in Regulatory Affairs to influence others to ensure departmental consistency and identifies options for risk discussions
Interacts with international marketing staff to define the most appropriate regulatory strategies to utilize in international product registrations, both in original submissions and to support existing registrations
Bachelor's degree in life sciences
4-7 years previous pharmaceutical drug development experience; six years in Regulatory Affairs
A track record of success associated with regulatory submissions to regulatory health authorities
Demonstrated knowledge of CMC, including regulatory registration of drug substances or drug

Regulatory Affairs Manager Resume Examples & Samples

Product Responsibility; New Product registration and Maintenance
Leadership; Actively support the learnings and the on boarding of the new joiners’ in the RA team. Provide proper support, knowledge and share learnings to make sure that the team is aligned with all corporate RA requirements and values. Technically support the team with their products of responsibility. Strengthen the META (Middle East, Turkey and Africa) and local RA collaborative relationship in coordination with the head of RA. Assist and support the direct report in developing and executing his/her development plan based on individual development needs against the agreed set of competencies
Cross function collaboration and customer focus; Maintain effective communication with key stakeholders in the Marketing, Medical Affairs, Logistics, and Finance & Administration Department. Active participation in all cross functional platforms by providing input and support on regulatory issues. In countries where required Review and sign off on promotional materials and participation in IBP process. Approval of clinical trial materials
Compliance: Ensure legal and governance compliance measurements relevant per environment and in line with Boehringer Ingelheim's 7 compliance areas

Regulatory Affairs Manager for Emerging Markets Resume Examples & Samples

Being the interface & contact partner for EM Regional Operating Unit (R(OPU)) RA teams and functions within GRA and other cross functional stakeholders
Being an integral member of the RA sub team, responsible for a particular Prescription Medicines (PM) therapeutic area and/or group of EM countries, contributing to the delivery of robust regulatory strategies for the EM to enable timely submissions and approvals aligned with global development plans
Involved in Regulatory Intelligence information gathering & impact assessment for the EM (i.e. Non-ICH countries outside the International Conference of Harmonisation) in collaboration with R(OPU) RA teams to ensure this information is globally shared, evaluated and implemented as per existing procedures
Being an expert on EM requirements in general and for the assigned PM therapeutic areas (e.g. Oncology, Cardiovascular)
Participate in coaching and developing R(OPU) regulatory staff
In collaboration with the Regulatory Intelligence & Process, Training & Compliance team in the roll out of new important procedures and compliance measures as appropriate to EM R(OPU)s
Represent the EM Region/ allocated sub-region at relevant project meetings and Regional conferences held by Boehringer Ingelheim
Support GRA functions and R(OPU) on other specific regulatory projects and issues

Regulatory Affairs Manager Resume Examples & Samples

Effectively manage Regulatory Affairs activities on regulatory projects and/or clinical trials being undertaken by ICON
Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs but may be concerned with: Agrochemicals, Cosmetics, Foods, Medical Devices and Veterinary products. Works on a range of regulatory issues in which analysis of situations or data requires an in-depth evaluation of diverse factors
May work either alone or as part of a regulatory or cross-functional team depending on the size and nature of increasingly complex projects
If acting as Regulatory Project Lead, responsible for managing each project and for monitoring and reporting progress and is accountable for all matters relating to that project and for communication with the client
Represent the Regulatory Affairs Department in business development activities
Recognize, exemplify and adhere to ICON's values which centre on our commitment to People, Clients and Performance
Primary point of contact between ICON and the Client
Production of project status reports at agreed intervals
Control of all project related documentation either in paper or electronic form
Minimum five years Pharmaceutical/CRO experience including minimum 5-7 years Regulatory Affairs experience or equivalent
Demonstrable experience within regulatory affairs, including document preparation and/or writing, clinical trials, post-licensing activities and regulatory agency interaction
Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail

Senior Regulatory Affairs Manager Resume Examples & Samples

Support Global Regulatory Lead (GRL) to generate novel and timely approval pathways (including fast track, breakthrough and orphan designation) in keeping with the needs identified by the business and markets and in compliance with relevant UCB procedures and local country regulations
Lead the planning, preparation and delivery of both simple and complex submissions for development products from either a global and/or regional perspective
Contribute to the generation of product regulatory strategy documents for products in phase 1-3 clinical development
Preparing and assisting in the preparation of high quality US and international regulatory submissions [e.g., IND ( initial IND, briefing documents, annual reports and other maintenance submissions), IMPD, CTA, BLA/MAA]
Assume assigned responsibilities for routine and non-routine contact with health authorities including coordinating and managing health authority meetings (e.g. pre-IND)
Ensure that appropriate, up-to-date records are maintained for compliance
Provide input into Regulatory Strategy Plans, resourcing, and project budget

Regulatory Affairs Manager, Director Resume Examples & Samples

End-to-end regulatory exam management, including JFSA and BOJ Proactive open issue tracking (MRA/MRIAs) and issue escalation
Regulatory change management and reach-out
Manage annual roll-up of MUFG and BTMU by primary regulators
Communicate continuously with Tokyo HO stakeholders, including but not limited to BTMU Global Planning Division and MUFG Government and Regulatory Affairs Office
Manage and coordinate senior executive communications with regulators
Proven track record in regulatory relations
At least 10 years’ experience in diverse business roles – e.g., revenue generating roles, program management, audit/compliance, managing staff functions
Strong analytical skills and problem solving capabilities
Strong work ethic, ability to make decisions, and work under tight deadlines

Regulatory Affairs Manager Resume Examples & Samples

Establishing and maintaining cooperative relationship with area Competent Authorities and promoting Edwards values
Providing guidance and managing the cooperation with local consulta
Preparation and submission of registration files to national authorities and monitoring their progress
Maintaining licenses current by resubmitting at appropriate intervals
Communicating promptly national requirements to RA EMEA and EEMEA leadership
Establishment of licenses and permits for all products codes, before distribution
Cooperating with Clinical Affairs in obtaining regulatory approvals for clinical trials
Reporting of AE/SAE from Clinical trials to local Competent Authoritie
Approval of labeling and promotional materials
Play active role in relevant working groups of local industry association
Minimum of Bachelor’s degree is required – preferably in natural sciences
Minimum of 5 years of professional experience in Regulatory Affairs is required – subject matter expert at manager level
Experience in medical device industry is strongly preferred
Experience from similar role managing RA activities in EEMEA region is a plus
Solid understanding of European and regional (EEMEA) regulatory requirements & procedures to obtain market access is required
Strong communication skills are essential

Regulatory Affairs Manager Resume Examples & Samples

Provide the leadership and delivery of global regulatory strategies for Monsanto's products in collaboration with colleagues in the global Regulatory organization
Develop and track project management plans and coordinate regulatory studies to ensure that appropriate national and requirements are met
Coordinate studies and agency responses to support regulatory strategies around the world
Prepare regulatory submissions, respond to questions from regulatory authorities, and develop other related documents (e.g., white papers, position statements, etc.) to obtain regulatory approvals in key export and production countries
Collaborate with the business teams on the identification, implementation, and management of regulatory acceptance and stewardship issues
MS in Biology, Molecular Biology, Chemistry, Genetics or related field of study
Excellent written/oral communication and organization skills
Ability to organize data and information effectively
Ability to write clear and convincing documents
Ability to work with customers to meet timelines and needs
Effective negotiation and persuasion skills
Experience with the regulatory approval process for biotechnology products
Experience interacting with key global regulatory governing bodies/agencies

Regulatory Affairs Manager Resume Examples & Samples

Develop and implement regulatory strategies based on in-depth knowledge of applicable law
Draft and review final regulatory applications
Manage regulatory submissions from Time of applicationto authorisation
Coordinate preparation of regulatory applications (science & cross-functional liaison)
Collaborate internally to design efficacy/selectivity trials for the CP and SAS portfolio
Coordinate the write up of and review Biofiles
Track progress of relevant competitor’s products
Provide regulatory support throughout product life cycle
Stay up-to-date with the latest developments in science, relevant legislation and guidelines
Master degree or higher in relevant scientific discipline, preferably in agronomy
Strong agronomy background
In depth knowledge of and experience with Regulatory efficacy dossiers for CP
Established experience in positioning and supporting product uses and benefits
Profound understanding of European and country regulations (crop protection -biostimulants)
Excellent communicator (oral and written) in English; more languages are an asset
Eager to learn
Engagement, commitment and perseverance are crucial qualities

Regulatory Affairs Manager France Resume Examples & Samples

Build strong regulatory and technical expertise and dossier preparation that will allow the support/defense of Monsanto's entire product portfolio (Crop Protection, Seed, BioAg, Biotech products and Home & Garden consumer)
Work with the French commercial team to understand and help the business/marketing functions to plan/prioritize the development of new products/marketing claims, achieve timely launches and maintain FTO
Build strong regulatory affairs relationships and networking with key members of the regulatory competent authorities and authorities responsible for the implementation of the Sustainable Use Directive, Water Framework Directive etc
Master the complexity of the regulatory framework in Europe and the country specific legal provisions in France for the product portfolio
Represent Monsanto’s views and defend Monsanto’s interests in key industry association committees, such as UIPP and UPJ
Master degree or higher in relevant scientific discipline
Regulatory experience (5 years): profound understanding of European and French regulations
Engagement, commitment and perseverance
Work efficiently with members of a diverse cross functional team to foster team work
Excellent communicator (oral & written) in French and English
Sense of ownership and responsibilities for his/her dossiers/submissions
Strong detail orientation
Crop protection knowledge
Eager to learn and to develop
Successfully demonstrates to lead through influence
Excellent planner, organizer and initiative taker
Employ project management skills and bringing organization to processes

Regulatory Affairs Manager Resume Examples & Samples

Manage Regulatory Affairs drug product development projects through entire lifecycle – from initiation through commercialization
Review drug product labeling components for all applicable Regulatory applications
Compose, review, and submit to the FDA original INDs, NDAs, ANDAs, supplements, amendments, annual reports, and periodic adverse event reports in electronic CTD format
Review all chemistry, manufacturing, and controls (CMC) documentation related to submissions
Complete electronic publishing of Regulatory submissions for submission to the FDA and other Regulatory authorities
Serve as the Regulatory representative on cross-functional teams supporting products throughout the stages of development and commercialization
Ensure Regulatory and cross-functional project strategies and submission timelines are in alignment
Develop and track Regulatory project timelines that incorporate all submission requirements including CMC, clinical, and labeling functions
Communicate Regulatory requirements and expectations to various contract organizations, including travel for on-site meetings as necessary
Evaluate proposed changes to approved products for potential Regulatory impact and gather required data as needed to defend a Regulatory filing strategy
Contact FDA and other Regulatory authorities for review status updates for pending applications and supplements
Author and review departmental SOPs, as well as any additional SOPs that may impact Regulatory affairs
Monitor various websites and publications to gather Regulatory intelligence on proposed product pipeline projects and any associated information
Perform due diligence audits of applications proposed for transfer from external partners. Review all documentation submitted throughout the lifecycle of the application and request any additional information prior to authorization of the transfer
Perform timely compilation of materials for license renewals, updates and registrations
Maintain Regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
Review changes to existing products and SOPs to define the requirements for Regulatory submissions
Provide the Regulatory reviews of customer complaints and define the Regulatory reportability
Responsible for timely registration of the facility
Actively participate in evaluation of Regulatory compliance of document/product/process/test methods changes
Research Regulatory issues and disseminate Regulatory information to Production, QA, QC and R&D departments and senior management as required
BS in a health, science or related field with 7 or more years of applicable US Drug Regulatory Affairs experience; advanced degree preferred
US Regulatory Affairs Professional Society Certification (RAC) is desirable
Experience compiling and filing electronic CTD submissions in the US
Experience with Regulatory timeline development and document tracking
Knowledge of FDA and international regulation, guidance and standards applicable to company products
Demonstrated leadership, excellent organizational skills and ability to work on a number of projects with tight timelines
Communicates effectively with fellow employees, patients, contractors, and vendors
High degree of accuracy and attention to detail
Strong interpersonal skills and an ability to build effective and constructive relationships
Self-starter and ability to work independently
Maintains confidentiality and security

Regulatory Affairs Manager Resume Examples & Samples

Develop and implement strategy for regulatory submissions for marketed and pipeline products, both biotechnology and ‘small molecule’, including New Drug Submissions, Supplemental New Drug Submissions, Clinical Trial Applications, Notifiable Changes and Notifications
Review of promotional materials
Review of labeling and artwork
Participation on cross-functional teams, locally and with the Amgen regional and global organization
Participate in Regulatory Affairs department initiatives
Other Regulatory Affairs responsibilities as required

Regulatory Affairs Manager, Russia Resume Examples & Samples

Reviews and provides technical advice to prepare regulatory submissions
Provides regulatory consulting and strategic advice to internal and external clients to determine the most appropriate regulatory and product development strategy for their products
Provides project specific GRA strategy, technical expertise and co-ordination oversight for key client’s projects
Ensures quality performance for key/managed projects
Liaises with PPD globally to support global projects
Assists business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure
Contributes to development & implementation of Global/regional function/plans
Participates as required in project Launch Meetings, Review Meetings and Project Team meetings
Good knowledge of global / regional / national country requirements -Regulatory Affairs Procedures for Clinical Trial Authorization, licensing, lifecycle management

Regulatory Affairs Manager, Nordic Region Resume Examples & Samples

Good knowledge of Nordics Regulatory Affairs Procedures for Clinical Trial Authorization, licensing, lifecycle management
Expert knowledge of ICH and other global regulatory guidelines
In-depth knowledge in one of the specialist areas; preclinical, clinical, or CMC, etc
Ability to discipline and reward employees and perform timely, effective performance evaluations
Good judgement and decision-making skills
Knowledge of budgeting and forecasting

Regulatory Affairs Manager Resume Examples & Samples

Provides regulatory support for diagnostic product development and commercial diagnostic products
Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the US and internationally
Works with governmental regulatory agencies and other third party accrediting bodies
Provides recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance
Reviews validation reports for regulatory submission soundness
Reviews advertising and promotion to ensure compliance with product claims
Develops internal procedures and tools
Conducts informational or training sessions for stakeholders
Organizes and maintains hard copy and electronic department files
Assists with hosting inspections, as needed
Assists with conducting internal/external audits, as needed
Assists with resource planning and budgeting, as needed
May supervise the activities of others
Demonstrates commitment to the development, implementation and effectiveness of Epocal and Alere Quality Management System per ISO, FDA, and other regulatory agencies
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
University Degree (preferably BSc, BEng or BA) and/or an equivalent combination of education and experience acceptable to Epocal
Minimum of 8 years of experience in Regulatory Affairs, US and international, preferably within ISO 13485 registered product development and manufacturing environment
5 or more years in an IVD or medical device manufacturing environment – preferred
Strong knowledge of federal and international regulations, and quality systems in regulated manufacturing environment
Compliance Experience
Honesty and integrity
Process orientated, logical, analytical, meticulous and highly organized
Effective oral and written communications skills
Adaptable and willing to take on multiple new tasks and responsibilities simultaneously
Ability to work effectively within a team environment while satisfying individual responsibilities and objectives
Ability to meet rigorous deadlines without a rigidly defined process in place

Scientific Regulatory Affairs Manager Resume Examples & Samples

Lead the initiatives to invest in science relevant to support the knowledge on the safety of our products and ingredients as the perception on them
Actively participate in the Food and Beverage Industry Association ANFAB, in order to be updated on proposals of regulations, discussions with the Government and taking the pulse of the Industry and how we can work with them the best way on projects or tasks of common interest
Maintain excellent contacts with local governments, health and customs authorities concerned with the beverage and food industry
Proactively and systematically identify and mitigate ingredient and product risks as well as seek for regulatory approval for new and emerging ingredients
Assisting regulators by attending and serving on appropriate committees including those involved with supra national activities like the Codex Alimentarius Commission
Developing relationships with the academy, scientists and other suitable consultants and work to eliminate science related roadblocks to our business
Coordinating with the local Company representatives of the legal, marketing, financial, public affairs departments concerning matters that may impact on their activities

Regulatory Affairs Manager Nordics Resume Examples & Samples

Be responsible for implementation of the European regulatory processes in the Nordics
Lead registration efforts in the Nordics to obtain and maintain all product registrations in line with all business strategies and needs
National Biocide registrations and implementation of BPR plans for Nordics
Dangerous products declaration, national registration of products for drinking water applications, local Vigilance System for Medical Devices
Provide regulatory support to all internal (e.g. sales force, manufacturing) and external (e.g. customers) interfaces in the country
Ensure Ecolab values and needs are represented at country federation level
Provide Regulatory training within Nordics internal organization and certain external customers
Setting up and maintaining all necessary project and regulatory documentation in line with the relevant Quality Management procedures and local regulations
Degree in Environmental Sciences, Toxicology, Chemistry, or Biology or other technical field pertinent to the role is required
At least + 5 years of experience in implementation of regulations in business or regulatory advocacy
Strong leadership and interpersonal skills, and an ability to develop strong working relationships with a broad range of internal and external professionals
Ability to effectively communicate and influence others across functions
Ability to organize and lead project teams
SAP knowledge at user level is valued
Fluent in Danish and English. Swedish, Norwegian or Finnish is preferable but not a requirement

Regulatory Affairs Manager Resume Examples & Samples

Write and support the preparation of clinical and regulatory documents required to support client’s global drug development and registration activities
Serve as the primary medical writing representative on assigned product teams and closely collaborate with personnel from clinical, regulatory and scientific departments
Manage the writing, editing and reviewing of diverse regulatory and clinical document including protocols, informed consents, clinical data summaries clinical study reports (CSRs), and other medical/regulatory documents including regulatory summary documents
Manage the quality, accuracy and compliance to internal and external standards and the timely production of English language documents
Plan and oversee regulatory activities for drugs and biologics for clients
Provide regulatory assistance or serve as regulatory contact for FDA or other regulatory agency submissions
Manage the regulatory submission process and regulatory agency interactions
Plan, schedule and direct activities and programs through regulatory staff
Working with a project coordinator, ensure maintenance of each development program’s applications, documentation, per regulations
Ensure CRO and consultant deliverables and activities are prepared or conducted on time and of high quality. Review study reports and related documents for compliance with regulatory requirements and good scientific principles
Prepare planning, strategy, summary documents, etc. for use in communicating with Sponsors
Provide expertise and strategy, to multi-functional project teams as the regulatory leader
Ensures compliance with GCP, GMP, and regulatory guidelines
Initiative and independence to identify short and long-term project needs, formulate plans for satisfying those needs, and identifying resources to implement project plans
MS degree in biology, chemistry or related field with 9 or more years of experience or Ph.D with 6 or more years of experience in drug development activities. RAC certification a plus
Experience with FDA drug and biologics development and experience interacting productively with regulatory authorities
Experience with clinical trials, maintaining essential documents, reviewing/writing protocols and clinical study reports
Ability to lead and work as a member of multiple project teams, and negotiate and achieve consensus in diverse groups
Ability to prioritize and multi-task concurrent project demands

Regulatory Affairs Manager / Senior Manager Resume Examples & Samples

Develop and implement regulatory strategies pertaining to specific projects to expedite the development, filing, and regulatory approval for new and existing products
Manage directed regulatory projects
Represent Regulatory on assigned project teams, providing appropriate advice and support to ensure compliance with all regulatory requirements
Interact with regulatory authorities regarding assigned projects
Prepare and manage various submissions and correspondence to Regulatory authorities ensuring adherence to national and international regulations and standards (FDA, MDD, Health Canada, Latin America or Asia)
Work with Technical Communications to publish and submit regulatory documents
Regularly interact with management regarding regulatory matters
Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies
Review of labels, labeling, advertising and promotional materials for compliance with local and global regulations
BS or BA in life sciences or equivalent with 5 years’ experience in Regulatory Affairs in the medical device, pharmaceuticals and/or biotechnology industry. BLA and/or PMA submission to CBER experience highly desirable
Advanced knowledge and experience in interpretation of regulations and guidelines
Ability to demonstrate thorough knowledge of FDA requirements pertaining to submission of regulatory documents
Strong communication (oral and written); interpersonal and leadership skills
Knowledge of QSR, and GMP requirements
Excellent project management skills necessary to perform complex tasks independently and with the ability to adapt to changes easily
Ability to work independently, take initiative and complete tasks to deadlines
Good organizational skills, self directed, and attentive to detail

Regulatory Affairs Manager / Senior Manager Resume Examples & Samples

Prepare and manage various submissions and correspondence to Regulatory authorities ensuring adherence to national and international regulations and standards (FDA, Health Canada, MDD and Turkey)
May supervise and provide guidance to other personnel
BS or BA in life sciences or equivalent with 5 years’ experience in Regulatory Affairs in the medical device, pharmaceuticals and/or biotechnology industry
Experience working with a biological product is desirable
Strong problem solving skills and ability to deal with changing priorities

Regulatory Affairs Manager Resume Examples & Samples

Understand and communicate regulatory requirements for both products (Regulatory Planning) and Quality Systems appropriate to Linkage Biosciences current and future products
Coordinate and author documents and assemble all materials required for regulatory submissions, license renewals and annual registrations
Identify, contract, and work with Authorized Agents/Representatives to support market entry
Maintain and update regulatory affairs procedures and changes
Recommend changes for labeling, manufacturing and marketing and clinical protocol for regulatory compliance
Maintain positive engagements and interactions with multiple regulatory agencies
Represent regulatory issues on cross-functional project teams
Provide straightforward guidance on document requirements prior to and during product development to ensure predictable regulatory filing dates and approvals
Participate in external and internal audits. Act as a cross-functional team member within the quality system
Help monitor, maintain, and improve the quality system
Act as responsible person in post-market vigilance systems, reporting and recalls
BS/MS/PhD degree in Biology, Molecular Biology or equivalent
Minimum 5-year experience in a regulatory capacity with a Class II or higher complexity medical device. IVD experience with molecular diagnostic products a plus
RAPS Regulatory Affairs Certification or a Regulatory Affairs Certificate a plus
Must have experience communicating with EU/US Regulatory bodies. Experience with other foreign regulatory bodies is desirable
Must have working experience with application processes for 510ks and CE mark technical files
Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, and 21 CFR 820
Experience in software development and software quality as it relates to regulatory submissions a plus
Ability to work with a team
Prior laboratory or marketing experience is helpful to understand the products and use
Travel expected to be not more than 10-15 percent

Regulatory Affairs Manager Resume Examples & Samples

Timely regulatory submissions in accordance with corporate and local strategies Maintenance of marketing authorizations to guaranty access of the products to the market
Local Pharmacovigilance responsibility for VMP: register and assess pharmacovigilance cases in cooperation with Global PV
Ensure the consistent and timely supply and release of high quality products according to Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP) guidelines
Handle the complaint and recall processes for AH products
Establish and maintain contact with internal and external stakeholders

Regulatory Affairs Manager Resume Examples & Samples

Implement registration programs to secure market authorizations to enable North Africa sales of Ecolab products
Prepares, coordinates and secures necessary authorizations, registrations and/or documentation needed for regulatory compliance against Egypt/ North Africa regulations concerning Ecolab products
Coordinate registration processes between Ecolab facilities and Ecolab distributors
Pro-actively maintains knowledge of regulatory requirements imposed by government agencies in the MENA
Research and monitor Trade Compliance and import/ export regulations
Support global and regional trade compliance programs and processes (eg. classifications, tariff codes, restricted party screening)
Assess and promote compliance with existing laws and regulations pertaining to the position
Develop and provide detailed understanding of regulatory processes of key agencies in the region
Supports and processes product set-ups and maintenance for trade compliance, goods movement compliance
Complete complex assignments which require specific regulatory knowledge and handle compliance issues
Build relationships with government agencies and the businesses
Provide subject matter expertise in North Africa regulations related to Ecolab products
The primary geographic emphasis initially will be on Egypt/ North Africa and MENA for Trade
Be able to use different systems to extract company data and info
Support supervisor in developing strategies to comply with regulations
Support supervisor or other regulatory personnel with special projects
University degree in pharmacology, chemistry, toxicology, engineering or related life science degree
Over 7 years professional experience in the area of Regulatory Affairs, Trade Compliance, Product Safety Product Stewardship, Marketing authorizations. Regulatory experience with disinfectants and sanitizers (biocides) applications
Track record of exposure to relevant regulatory agencies and customs (Egypt, MENA)
Experience with governmental regulatory programs such as MOH, municipalities and other international regulations
Familiarity with regulatory requirements and standards governing trade compliance, import, distribution and sales in MEA
Must possess a high level of autonomy and be able to succeed under remote leadership
Demonstrated grasp of business and regulatory processes
Professional use of the English, Arabic and preferably in French both written and oral
Familiar with Hazard communication (MSDS, labels, GHS)
SAP enterprise software skills is a plus
Good with Microsoft application, Excel, word, Power point

Regulatory Affairs Manager Resume Examples & Samples

Provides regulatory and technical support to other departments
Shapes healthcare environment
Actively involved in Cross functional activities
Handles registration projects (CTA/NDA/BLA/other applications) for Onco new product and global R&D development and/or maintain established products according to the regulations and registration plan
Cooperates with headquarter and management to establishes registration plan and strategy
Provides guidance and advice to subordinates on regulatory affairs to ensure registration projects completed timely
Interact with HA officials, reviewers and experts and provide training
Develops internal policies and procedures
Support function departments on new product launch and compliances

Regulatory Affairs Manager Resume Examples & Samples

Collaborate with operations to review, analyze, and develop/oversee initial implementation project plans and / or corrective action plans to ensure compliance with new or existing laws and regulations and company, customer and accreditation requirements
Track and analyze all new regulatory requirements pertaining to public sector and commercial lines of business
Prepare summaries of analysis that include, as appropriate, relevant legislative history, comparisons to existing or proposed legislation in other jurisdictions and detailed descriptions of the operational requirements and affected departments
Consult and coordinate with new business / sales / product development to determine all regulations pertaining to any products being offered in the marketplace
Review benefit plans for compliance with state mandates
Lead a team
5+ years of experience in a health care regulatory environment
Experience dealing with insurance contracts and interpreting insurance statues and regulations
Strong ability to establish positive relationships across business groups internally
J.D
Experience dealing with commercial health insurance products - Individual and Group

Regulatory Affairs Manager Resume Examples & Samples

Conduct quality assurance of compliance documents
Provide input concerning material regulations into the relevant Forums in respect of allocated regulatory requirements
Attend to Regulatory queries related to Financial Crime matters
Share regulatory, technical product and transactional knowledge of the business across the Compliance function
Develop relevant compliance tools for allocated regulatory requirements and policies to assist business in the management of the associated compliance risk

Senior Regulatory Affairs Manager Resume Examples & Samples

Maintain a high level of product knowledge through familiarity with medical and scientific literature for all Abbott EPD products and the pipeline portfolio
Develops and maintains updated knowledge of applicable current global/regional Abbott EPD regulations and guidelines
Attendance of relevant external international and local regulatory/ /quality conferences to maintain subject matter knowledge

Regulatory Affairs Manager, Argentina Resume Examples & Samples

Work in collaboration with key LatAm functional areas (Commercial, Med affairs, Legal/Compliance, Finance, HR) ensuring that RA strategies are aligned with BMRN´s commercial objectives
Manage the planning and preparation of complex submissions including but not limited to the following: Marketing Application (including content development, assembly of the dossier, submission, through approval); post-marketing maintenance including partial change applications, clinical and nonclinical updates are prepared in accordance with Colombian regulations. Interface closely with U.S. and other global BioMarin offices to align strategies
Develop Argentina Regulatory filing strategies and identify risks and potential gating factors. Evaluate regulations/guidances and participate in industry trade organizations in order to advise BioMarin on the Argentinean Regulatory environment and changes that could affect BioMarin’s products or plans. Prepare regulatory intelligence reports to communicate any changes or updates on regulations to internal teams
Serve as primary liaison with the Regulatory authorities (e.g., ANMAT) and interface on behalf of BioMarin to negotiate as needed to support plans for new drug registrations and activities for existing product licenses.Assist in preparation for and execution of Agency meetings
Manage Argentina product licenses and lifecycle, including maintaining as current the administrative, clinical, CMC, and nonclinical sections
Work closely to the Argentinean Company chosen to represent BioMarin before ANMAT
Identify and manage local Argentinean regulatory consultants and contractors, and liaise with them as needed for projects
Actively participate in multi-functional global team environment, and clearly communicate RA activities to regional office and headquarters to ensure strategic alignment

Regulatory Affairs Manager Resume Examples & Samples

Development and execution of regulatory strategies for assigned development projects within the business unit implant systems
Technical or scientific background, university degree is an advantage
Experience in preparations for notified body audits and FDA inspections
Highly organized and able to work under strict time lines

Regulatory Affairs Manager Resume Examples & Samples

Provides support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements
Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations
Manages submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings
May review, interpret, and report Regulatory leadership on product specific regulatory issues that may have material impact on the business units, the corporation, or the customer. May work with Regulatory Affairs leadership to develop strategic and tactical responses to influence a reasonable regulatory environment
Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects
Interfaces with regulatory authorities on regulatory and technical matters, as appropriate
May provide consultative and training support to the business unit and core regulatory personnel related to premarket submissions, product labeling, and complex submissions issues

Regulatory Affairs Manager / Consultant Resume Examples & Samples

4+ years of relevant Regulatory Affairs experience in a Pharmaceutical, Biotechnology CRO, or related environment
Bachelor's Degree in a Scientific discipline
Demonstrated, hands-on experience facilitating and preparing Regulatory Submissions
In-depth knowledge of IND Regulations according to CFR (Title 21), FDA and ICH guidelines, including thorough knowledge of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) policies and procedures
Current knowledge of Global Regulatory standards, Registration requirements and approval policies and procedures
Demonstrated understanding of Clinical Trial Conduct, Data Acquisition, and Reporting
Understanding of the Quality Assurance (QA) function as it applies to regulatory documents including the ability to review and Quality Control documents intended for regulatory submissions
Knowledge of US and European Regulatory and Clinical Trial requirements
Experience and familiarity with Regulatory Intelligence Databases

Regulatory Affairs Manager Resume Examples & Samples

New Product Registrations – With minimum supervision, evaluate, prepare and submit drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve a favorable outcome
Maintenance of registered products – With minimum supervision, maintain registration of currently approved products
Product Information and Consumer Information – With minimum supervision, maintain product information and consumer information ensuring the correct use of the approved versions of these documents
Company Licenses and Pure Substance– Responsible for the maintenance and implementation of relevant importation and exportation licenses and the coordination of pure substance requests
Relationships within and outside the company - Develop and maintain good working relationships with other Novartis departments both locally and with Head Office and with health authority and industry bodies, such as the SFDA
Provide valuable regulatory advice as necessary
Assist Medical Information and Quality Assurance with product detail requests wherever feasible. Assist Training Manager with Product Information training requirements wherever feasible
Provide adequate training and guidance to all junior regulatory associates as requested by Regulatory Affairs Head

Apparel Regulatory Affairs Manager Resume Examples & Samples

Ensuring that regulatory requirements are met for Amazon Private Brands/Label Softlines products (EU focus) and support other functions such as Retail, Transportation, Customer Service, and Legal
Work cross-functionally and manage compliance training and awareness raising programs in retail, operations and sales teams
Develop best-in-class processes and systems, and drive continual improvement
Knowledge of product compliance processes and the interplay with global supply chains
Collaboration, Influencing, Negotiation, Determination and Resiliency
Bachelor’s degree required with a scientific focus
7-10 years of experience with import/export consumer product safety compliance program management and in-laboratory experience
Strong experience with global regulatory requirements such as: EN 71, CPSIA, FTC, CCPSA, , RSL, REACH, NOM-004, NMX, JIS, China CIQ / GB, etc
A mix of compliance and project management experience
Knowledge and experience with regulatory compliance for apparel & home textiles: clothing, children's, sleepwear, bedding, sheets, men's, women's, private label
Must be able to think creatively and possess strong analytical and problem solving skills
Previous experience in a consumer apparel/home textiles company, e-commerce environment or other fast-paced, technology driven businesses a strong plus
Good problem solving skills: acts decisively, promptly and confidently. Not afraid to contradict others and proactively offering solutions
Strong problem solving, initiative and follow-through skills
Strong presentation/ training delivery experience
Key Competencies: A-Z process ownership; deals well with ambiguity, function well and able to clearly define processes in loosely structured situations; comfortable with following up actions from others

Regulatory Affairs Manager, Singapore Resume Examples & Samples

Monitors and evaluates changes and proposed changes to health authority and regulatory requirements and industry standards and provide regulatory intelligence to SEA and Global regulatory partners
Deploy new or updated requirements via the Quality Management System
Responsible for providing country input into regional/ global regulatory strategy for new processes, projects and etc
Build constructive relationships with the local health authority
Collaborate and engage cross sectors Regulatory Affairs team in RA council meeting
Established and maintain SOPs on regulatory affairs departmental work processes
Act as auditee/ SME for regulatory issues in internal and external audits
Work closely with commercial team to ensure timely launch of new products
Have oversight departmental database to ensure proper tracking system is in place
Manage departmental budget and resource allocation
Manage and develop direct reports

Regulatory Affairs Manager, Japac Resume Examples & Samples

Primary interface with local health authorities via RA personnel in the affiliates
Provides leadership and support to RA personnel in the affiliates. Assesses scientific data for registration purposes against JAPAC national and regional regulatory/clinical requirements, identifying gaps and developing mitigation strategies to address gaps. Ensure effective presentation of data, complete and timely responses (including CTAs)
Implements Area Regulatory Strategic Tactical Plan for assigned projects for countries in JAPAC region in conjunction with the Global Regulatory Lead and other RA sub-team colleagues as appropriate
Represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team (GRPT) to ensure those are met
Represents the JAPAC regulatory function at sub-teams or client group meetings (i.e. commercial R&D, CMC, etc.) to present regulatory requirements or provide strategic input for the registration of products
Actively supports R&D and affiliate regulatory and clinical operations teams in securing timely approval of registrational clinical trials
Actively participates in the development of training programs and other area regulatory initiatives for JAPAC affiliates
Ensure regulatory compliance for the assigned compounds/products. Implement remediation plan to address identified gaps, if any
The incumbent is responsible to provide support to RA personnel in the affiliates to support the registration of the products in the assigned therapeutic area in a timely manner
The incumbent acts as the representative for RA on the Strategic Brand Teams for the Area
The incumbent is accountable for representing RA to the area commercial organization and ensuring that commercial priorities are communicated and integrated into the global regulatory strategies
The incumbent is expected to communicate changes in regulatory requirements that may impact the data requirements or timelines for gaining and/or maintaining marketing authorization applications
The incumbent is responsible to ensure regulatory compliance for the assigned compounds/products
The incumbent works on assigned work processes in order to achieve the program objectives established by senior management
BS degree in pharmacy, pharmacology, biology or related subject
Minimum 5 years’ experience in Regulatory. At least 3 years’ experience in JAPAC regulatory in new drug applications for NCEs, clinical drug development and clinical trial applications
Have in-depth knowledge of the regulatory requirements of the countries within the JAPAC region
Clinical drug development experience in Oncology compounds will be an advantage
Proven interpersonal skills

Crop Protection Regulatory Affairs Manager Resume Examples & Samples

Developing and implementing regulatory crop protection strategies for Africa
Project management for all crop protection in Africa, including preparing and managing regulatory submissions for new registrations and renewals, coordinating responses to questions from regulatory authorities and developing other related documents (e.g., white papers, position statements, etc.) to obtain regulatory approvals
Providing expertise to address crop protection inquiries from internal and from external distributors/ registration holders
Performing regulatory assessments
Providing regulatory advice, coordination and training of country Regulatory Affairs Managers
Represent Monsanto on relevant local or regional industry crop protection associations to affect policy creation to maintain and increase our freedom to operate
Ensure regulatory compliance for all crop protection aspects in Africa. Liaising with key internal and external stakeholders both for the region and globally to facilitate Monsanto’s business operates in compliance to local, regional and international laws
Issues management and incident response reporting for crop protection in Africa
Life sciences degree in Plant Breeding, Plant Sciences OR degree in Chemistry, Biology, Genetics or related field. Or 5 years of related experience
Extensive experience with the regulatory approval process for Pesticide or Biotechnology products

Biotechnology Regulatory Affairs Manager Resume Examples & Samples

BS with 7+ years relevant experience or MS or Ph.D. in Molecular Biology, Crop Science, Genetics, Plant Breeding, Plant Pathology, Biochemistry, Protein Chemistry, Toxicology or related scientific discipline
3+ years relevant experience in the agricultural, biotechnology, pharmaceutical or related scientific based industry
Excellent written/oral communication and organization skills are required
Effective negotiation and persuasive skills
Employ project management skills
Ability to successfully interact with a wide diversity of people and government agencies
Successfully demonstrates the ability to lead through influence
Experience and/or an understanding of regulatory processes for biotechnology products and interactions with key global regulatory governing bodies/agencies

Regulatory Affairs Manager Resume Examples & Samples

Acts as a Lead Regulatory Professional on any type of writing or technical project, with limited guidance from senior staff using experience and initiative to generate new and unusual document types to meet customer requirements
Provides strategic regulatory and/or technical consultancy on a variety of projects and provides senior review and guidance for most documents prepared by junior colleagues
May act as a Project Manager for a stand-alone project, with full project management responsibility
May prepare a single service regulatory or technical proposal for senior review and/or propose budgets for less routine projects, out of scope activities and potential budget efficiencies. Deliver business development presentations to customers with confidence and detailed knowledge, as directed
Independently meet with customers face to face to discuss project status. Identifies creative solutions to challenges that are acceptable to Quintiles and customers, thereby consistently receiving positive customer feedback
Ensures compliance with regulatory processes, ensuring readiness for internal or external project audits
May design training materials and deliver training externally and internally
May represent region or site on a regulatory, technical or cross functional Initiative
Performs other tasks or assignments, as delegated by Regulatory management
Degree in life science-related discipline or professional equivalent plus at least 6 years relevant experience* including 4 years regulatory experience or high school diploma plus 10 years relevant experience* including 6 years regulatory experience (*or combination of education, training and experience)

Regulatory Affairs Manager Resume Examples & Samples

The candidate needs to have rich experience with ANDA compliation, ANDA filing, Regulatory responses, FDA guidelines etc.Primarily responsible for ensuring ANDA or OTC monograph are compliance with 21 CFR and applicable FDA guidance's
Provide support in formulating and implementing regulatory strategies for the development of Oral solids generic products and regulatory activities in line with US FDA and ICH guidelines
Work very closely with all relevant departments at the time of product initiations, R&D phase, execution and after initiation of stability to ensure timely availability of all documents for filing the ANDAs
Prepares full responses to triggered FDA labeling deficiency letters for commercially marketed products or listed drug updates via a supplement or amendment
Responsible for GDUFA self-identification, establishment registration and fee payment for all the facilities
Compile, review, and submit DMF annual updates, amendments, letters of authorization, and customer notifications
5 to 7 years of pharmaceutical regulatory affairs experience is Mandatory
Strong knowledge of ANDA Submission experience along with experetise and using several softwares like ECTD, PHARMA READY, etc., for ANDA Filings like
Expertise with Microsoft Office Suite, Electronic Document Management Systems
Proven ability to work independently and need to manage 5-8 people team
Capable of interacting with technical groups and understand complex issues pertaining to CMC, packaging, and testing
Position is located at New Jersey and candidate should be working onsite everyday

Senior Regulatory Affairs Manager Resume Examples & Samples

MS in life sciences or related field and 8+ years’ experience in food- or biotechnology regulatory affairs or PhD with 5+ years relevant experience
Knowledge of regulatory requirements to gain approval of enzyme products in main markets in Asia Pacific. General knowledge of scientific methods in R&D and Quality
Proven track record of successful submissions and influence of regulations/regulators in one or more relevant areas (food, feed, chemicals)
Successfully impacted product introduction and product compliance by providing regulatory guidance and/or successfully influenced decisions at plants to implement change
Demonstrated strong influence on the success of future products and processes, and forming influence on the department (can be in non-technical/scientific manner)
Successfully analyzed problems that require an in-depth understanding of the organization
Consistent proactive & interpreting attitude towards clients’ issues and track record of being a strong team player
Excellent skills in influencing and supporting others
Abstract conceptualization, problem solving, and critical thinking skills
Ability to stay focused working in independent working environment
Excellent communication skills in English (verbally, in writing, and in presentations), and preferably one regional language. Competency in computer/software tools needed for job

Regulatory Affairs Manager Resume Examples & Samples

Develop strategy and networks to enable regulatory solutions to support both product and technology innovation delivery
Champion advocacy, compliance & sales activity across the DuPont N&H businesses
Approve marketing materials
MS in life sciences or related field and 10+ years’ experience in food and/or dietary supplements regulations or PhD with 8+ years relevant experience
Understands commercial drivers and is comfortable in planning and managing resources within budget constraints (finding cost effective solutions)
Knowledge of regulatory requirements and ability to comply and lower barriers to trade through interpretation of regulations and ability to influence
Proven track record of successful submissions and influence of regulations/regulators in food, food ingredients, dietary supplements and related pharmaceutical standards
Ability to deal with ambiguity and communicate recommendations on options to solve business problems clearly
Honesty in defining gaps and failures, and find solutions to improve and/or find solutions to achieve business goals. Successfully analysed problems that require an in-depth understanding of the organization is a plus
Consistent proactive and problem solving mindset putting internal and external customer’s priorities at the core. Having track record of being a strong team player is a must
Ability to function in multidisciplinary and virtual environment
Flexibility to accommodate occasional after hours work as global needs require
Excellent communication skills in English (verbally, in writing, and in presentations), competency in English and command a working knowledge of another Asian language is an advantage

Regulatory Affairs Manager Resume Examples & Samples

PhD. (or MSc. + experience) in life sciences (Veterinary Medicines , Pharmacy or Biology)
Knowledge of research, production and/or control of veterinary products is an advantage
As a senior you’ll have at least 4 years of experience in the licensing of drugs (preferably for veterinary medicinal products)
Flexible and persistent personality
Fluent in English in speaking and writing and preferably a thorough command of a second European language
Team player and able to work I with specialized teams
Able to analyze complex situations and find adequate solutions
Hands-on manager being able to cope with temporary stress and deadlines

Regulatory Affairs Manager Resume Examples & Samples

Contribute to the development of the Regional RA CMC strategy
Execute the preparation of CMC components of CTA and NDA filings for all Amgen products in collaboration with the RRL and RA CMC JAPAC Regional lead
Organize and prepare CMC investigational product amendments and post-market supplements in collaboration with RA CMC Global Lead
Ensure appropriate compliance with archiving/tracking and monitor metrics from tracking systems including IMR
Oversee all regulatory obligations in relation to the region under responsibility, work with the team and cross functionally to ensure any necessary alignment to these obligations
Conduct contingency regulatory planning/risk assessment for regional development and regulatory interaction strategies
Degree in Life Science
Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
Regulatory CMC experience. CMC-specific regulatory knowledge & experience
Strong & effective oral and written communication skills
Proven ability to communicate effectively with different management levels
Microsoft Outlook/ Word/ Excel/Power Point/Project
Language: ability to speak and read one or more of the following language preferred: Mandarin, Japanese, Korean, Taiwanese

Regulatory Affairs Manager Resume Examples & Samples

Bachelor's degree or higher in a Science or Engineering discipline from an accredited institution
Minimum of three (3) years regulatory experience
Bachelor's degree or higher in Biology, Chemistry, Chemical Engineering or related discipline from an accredited institution
Minimum of five (5) years regulatory experience
Understanding of quality systems requirements for medical device, drug/device combination products and HCT/Ps
Detailed oriented, ability to navigate matrix environment

Regulatory Affairs Manager Resume Examples & Samples

Bachelor's degree or higher in Biology, Chemistry or Chemical Engineering from an accredited university
Minimum of three (3) years regulatory experience working with drug products
Minimum of five (5) years regulatory experience working with drug products
Understanding of quality systems requirements for drugs and drug/device combination products
Previous experience with inhalation or trans dermal products

Regulatory Affairs Manager Haarlem Resume Examples & Samples

For assigned products, ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities and – as applicable – to the EMA
Ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations
For assigned products ensures timely, accurate and compliant labeling translations and artwork preparation
For assigned products and tasks, stays updated on late MSD pipeline filings, relevant EU and local regulations and guidelines and to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans, as necessary
Collects relevant public available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed
For assigned products and tasks, works alongside the BD, locally, regionally and globally, to support business initiatives in sub region
Maintains a positive relationship with internal and external regulatory contacts. GRSPS on sub-regional, regional and global level, Manufacturing Division, EUPV and WPS are the main contact points within the company. External contacts are regulatory authorities, as well as other key players in the regulatory environment
By discretion of Regulatory Affairs Management and due to organization and work load, all listed activities need not to be performed
7 years’ experience in a Registration Department or equivalent, which should include dealing directly with regulatory Agencies
Familiarity with local and EU legislation procedures and guidelines governing pharmaceutical products
Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills
The incumbent should possess a meticulous attention to detail, and be flexible enough to successfully handle conflicting time pressures and a large volume of work
A mature and disciplined approach to work is essential as is the ability to coordinate the work of others
The incumbent should be able to demonstrate diplomacy and assertive skills in dealing with internal and external parties
The incumbent must demonstrate proficiency in local and English language as well as PC use with regard to word-processing, spreadsheets, database application, and internet

Regulatory Affairs Manager Resume Examples & Samples

Provide direction and control of nuclear regulatory affairs activities to ensure business strategy is implemented and Regulatory lines to take are followed
Management of the strategic relationships with ‘nuclear’ regulators. Monitoring the effectiveness of regulatory relationships, establishing and reviewing goals and objectives. This will include the development management arrangements and KPIs to support the management of the quality, efficiency and effectiveness of regulatory interaction
Ensure that programmes of work with the regulators are developed, maintained coordinated and coherent, including programme management of all regulatory cornerstones and associated topic streams
Ensure that intelligence is gathered and Regulatory Lines to take are maintained in close association with the corporate affairs team
Ensure Regulatory lines to take and issues are communicated across all cornerstones and topic streams to ensure effective escalation within the Level 1, 2, 3 and 4 structure
Ensure effective reporting on progress on regulatory interactions, advice and assessment, assisting the business in identifying and managing areas that require remedy and improvement
Ensure regulatory obligations and formal commitments are effectively managed
Develop a close working relationship with the Hitachi-GE GDA team to ensure that the transition of regulatory interactions from GDA to site specific licensing and permitting is efficient and effective
Significant experience and knowledge of the UK nuclear industry and its regulators including UK regulatory requirements
Strong planning, prioritisation and delivery skills including effective reporting skills
Experience of developing, implementing and overseeing processes and procedures
Good understanding of site licensee organisation requirements and safety case production, preferably in the UK
Demonstrates high levels of personal impact and proven ability to influence positive business outcomes

Associate Regulatory Affairs Manager Resume Examples & Samples

Coordinates the RA activities for direct reports
Manages RA responsibilities and functional goals which may consist of FDA and CR.Bard required filings and new information dissemination
Involved with the coordination and management of technical file audits, FDA audits, and internal audits
Demonstrated communication and technical writing skills
Knowledge of US labeling requirements including promotional materials, and experience in decision making associated with product labeling and promotional materials
Experience working in a multi-level corporate environment typical of large corporations
High analytical evaluation skills
Good managerial/supervisory skills

Regulatory Affairs Manager Resume Examples & Samples

Regulatory Management: With respect to each research project, the work to be accomplished will be delineated by the processes and procedures defined by the University of Chicago's IRB and other regulatory agencies including the FDA, as well as study sponsor requirements
Industrial, Institutional and Federal Interface: Liaison between the Principal Investigator and external sponsor and funding source representatives to provide required regulatory documents and coordinate responses to the Institutional Review Committee (IRB) and external agencies (including NCI and the FDA)
Education: The RAM will refine existing training procedures and develop additional training for the clinical research staff across departments
Quality Assurance/Quality Control: The RAM will implement quality control procedures for review and preparation of accurate regulatory documents for submission to the Institutional Review Board (IRB), the Clinical Trials Review Committee (CTRC), NCI, FDA, and other external sponsors

Regulatory Affairs Manager Resume Examples & Samples

Mentor and develop staff of regulatory professionals and assign regulatory affairs representatives to serve as US and/or global team and sub-team regulatory leaders as needed
Responsible for understanding regulations for international, federal, state and local regulatory and compliance agencies
Serve as advisor on regulatory issues for both marketed and pipeline products; actively collaborate with management and cross functional colleagues
Responsible for filing all appropriate registrations and license to meet international, federal and state requirements
Provide expert regulatory affairs review, input, opportunity and risk assessment into confidential, strategic and often complex due diligence initiatives
Provide input into draft FDA Guidance and policies, working closely with the global head of Regulatory Policy and Intelligence, EU RA and global government affairs staff
Identify and escalate any unresolved regulatory affairs compliance concerns to the VP, Regulatory Affairs Americas and/or the SVP, Global Regulatory Affairs
Designated Representative for the medical device distributor license
Ensure exemplary behavior, ethics and transparency within the company and with regulatory agencies
Responsible for maintenance of all product filings and files and assists in regulatory and compliance audits
Responsible for understanding US FDA and international regulations
Develop regulatory filings (510(k), PMA, IND, BLA) for our products
Maintain periodic registrations and licenses (local, state, and federal)
Assist in communications with regulatory bodies
Responsible for handling, investigating and reporting adverse events for products manufactured or distributed by company
Review and approve change orders, deviations, and corrective actions for product changes and/or, modifications related to manufacturability and/or, material modifications to ensure compliance
Assist department and act as Audit Leader for internal and supplier audits
Provide department support during FDA, Notified body, and other external or internal audits
Provide department support during any product recall or market withdrawal
Create, maintain and support Regulatory Affairs processes and procedures
Comply with all company policies, procedures, and SOPs
Perform other duties, including travel, as assigned by Supervisor
Strong knowledge of device/product development and regulatory policy; excellent scientific and business judgment
Experience providing strategic regulatory advice for the global development of products through all stages of development including pre-approval and marketed compounds
Ability to manage complex issues and coordinate multiple projects simultaneously
Ability to build team relationships and collaborate in a global team environment at all levels of the organization
Adept at change management
Strong interpersonal, communication and leadership skills
Proven track record practicing sound judgment as it relates to risk assessment
Highly conversant and knowledgeable of new and emerging regulations and guidance. Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information

Regulatory Affairs Manager Resume Examples & Samples

Identify and specify the regulatory provisions of Latin America and Canada to provide the concerned structures with solutions
Plan for necessary resources; recruit, and development of direct reports
Establish registration schedules consistent with the business strategy, in close collaboration with the subsidiaries
Manage (Pre) registration, renewals and changes for in vitro diagnostic medical devices (Reagents & Instruments)
Define, improve, update and implement regulatory procedures, mainly those related to obtaining and renewing approvals from the concerned countries
Provide feedback on the effectiveness of the regulatory processes (strategy, applications review with questions/answers, issues and problem resolution) and contribute to improvement plans
Bachelor degree in Science or Engineering
Minimum of five years’ experience in regulatory affairs, ideally in the field of medical devices IVDs/MDs (reagents and instruments)
Working knowledge of regulatory requirements, guidance documents and processes (local/regional)
Some prior management experience preferred
Preferred but not required: Fluent in Spanish or Portuguese, both written and spoken
Can demonstrate rigor, organization and responsiveness
Excellent communication, organizational and problem solving skills required
Selected individual will be able to manage to organizational priorities and deadlines while being dynamic to adjust to the changing regulatory environment
Can work in an International environment
Mentor and share experience
Analysis of moderate complexity issue and problem solving
Influence, challenge and negotiate

Regulatory Affairs Manager Resume Examples & Samples

Prepare, submit, and manage regulatory clearance applications required for product market approvals in the US and Canada
Prepare, submit, and manage European Design Dossier/Technical Files in compliance with the requirements of the Medical Device Directive and the Accuray Quality Management System
Function as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams
Assist research personnel, application specialist, risk management specialist, to ensure clinical research and clinical evaluation are performed in accordance with necessary regulatory requirements
Participate as subject matter expert in internal and external quality system and design dossier audits
Gather and prepare materials to enable Medical Device Reports, Vigilance, Adverse Events, Recall, etc. decision making processes
Collate and prepare materials, reports, and follow-up actions with regulatory agencies regarding recall activity
Co-ordinate international reporting with regional representatives
May prepare documentation and reports after interpretation of federal, state, and/or international regulations for submission to other units of the company, customers, governmental regulatory agencies, etc
Bachelor's degree in business, engineering, or a physical science discipline
Minimum of 7 years of experience in regulatory and/or quality assurance in a medical device development and manufacturing environment
Solid working knowledge of the global regulations and standards applicable to medical device market clearance
Proven track record clearing medical devices to market in the US, Canada, and Europe
Proficiency in working through third parties to obtain market clearance in other countries
Excellent verbal and written communication skills; strong attention to detail
Strong interpersonal skills and cross-cultural competency to enable building of trusting relationships across functions and geographies
Ability to travel domestically and internationally up to 10% of time

Environmental Regulatory Affairs Manager Resume Examples & Samples

In-depth knowledge of environmental control principles
A broad understanding of PPG business requirements, regulatory environmental requirements, and the ability to assess critical issues and make decisions accordingly
The ability to influence Senior Management or Regulatory Officials

Regulatory Affairs Manager Resume Examples & Samples

Prepare, assemble and submit regulatory submissions, such as CE Mark Technical Files, Summary Technical Documents, Device Design Dossiers and other international regulatory submissions in various countries within European, Middle Eastern and African (EMEA) regions
Provide input for regulatory requirements and regulatory strategies in interdepartmental meetings on product development to ensure timely submission and approval. Determine regulatory filing strategies and submission types. Participate in medical device product development teams and develop overall regulatory strategy that delivers on project costs, timeline and FDA approval. Ensure that project work proceeds according to agreed deadlines and maintain status records
Responsible for performing all duties in compliance with ISO13485, Medical Device Directive 93/42/EEC (and all applicable amendments), Personal Protective Equipment (PPE) Directive 89/686/EEC, FDA's Quality Systems Regulations, GMP's, Canadian Medical Device Regulations; and other international regulatory requirements. The manager will also compile and/or review all regulatory agency submission materials to ensure timeliness, accuracy, completeness, and compliance with regulatory standards
Responsible for regulatory related design and development activities, including providing input on materials, testing, validations, and other outputs to demonstrate compliance with regulatory requirements
Participate in root cause analysis, corrective and preventive actions for product and process issues, including internal and external audits, as necessary
Maintain regulatory affairs documents and systems including the Regulatory Product Submissions and Regulatory Tracking database
Evaluate changes to controlled documents for impact on submissions and filing requirements, including providing a technical review of and approval for proposed changes and supporting documentation. Make recommendations for regulatory and compliance operating procedures and may be responsible for creating and reviewing SOPs as needed
Provide input on and review of protocols and reports for: design verification and validation for material, process and facilities changes, assay/method validation, shelf life, clinical and non-clinical studies, material qualification and safety testing in support of product submissions and marketing collateral
Determine governmental regulations affecting Company processes and assure the processes are complete and accurate to ensure company compliance. Formulate and implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
Act as liaison for Company with regulatory agencies, as well as with other internal functional departments for new product submission strategy. Participate in regulatory agency inspections such as Pre-Approval Inspections, Quality System Inspections, and cGMP inspections
Review technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry
Bachelor’s Degree in a scientific discipline or a related field required. Advanced degree is preferred
Regulatory Affairs Certification (International)
5-8 years of experience in managing Regulatory Affairs for medical devices is required
Proven experience with preparation of regulatory submissions, such as CE Mark Technical Files, Summary Technical Documents, Device Design Dossiers and other international regulatory submissions in various countries within European, Middle Eastern and African (EMEA) regions
Demonstrated track record of successful regulatory approvals for medical devices and/or combination products in the EMEA markets
Proven experience with new product development, design controls, quality system
Demonstrated track record of successful negotiations with Global regulatory agencies with respect to product submissions and regulatory strategies
Knowledge of FDA's Quality Systems Regulations, GMP's, ISO13485, Medical Device Directive 93/42/EEC (and all applicable amendments); European PPE Directive 89/686/EEC, ISO regulations/standards, including ISO 13485, 10993, 14971
Expertise in technical and operational aspects of regulatory affairs, combined with scientific understanding and strong project management
Expertise in Microsoft Office applications is required, specifically Microsoft Word, Excel, Outlook, Project, PowerPoint, and SharePoint

Regulatory Affairs Manager Resume Examples & Samples

Perform Regulatory & Customer impact assessment for Change Controls and new products
Defines a regulatory strategy for a less burdersome approach for expedited approvals and streamlined maintenance of the licenses
Creating and coordinating the content of Regulatory Files for changes and new products
Defines the reports and studies that will be required in these submissions. Will work with R&D, Clinical Affairs,TD, MS, Production, Engineerig and QA to get these documents in an understandable and shared approach
Coordinate the regulatory Technical File and provide the required documents for NASSRA to submit to Regaulatory entities
Create the documentation needed for customers in coordination with the Grifols Alliance Responsible that will deliver to the customer
Defines the Labeling content
Together with The Technical Director and the Medical Affairs groups perform Risk Analysis for MDR or BPDRs. Write and submit the MD and BPDRs
Co-Review together with NASSRA for advertising and promotional labeling
Serve as regulatory subject matter expert for design control, development and compliance projects and define implementation of new IVD regulatory a non-IVD regulatory guidances
Solve problems and make decisions in a cross-functional team setting
Manage partner and critical vendor relationships as appropriate to ensure compliant submissions
Assist in preparing budgets and timelines for Trials and Registration activities
Participate on multidisciplinary teams focusing on continuous improvement and management initiatives
Demonstrate strong verbal and written communication skills
Assume a lead role in the completion and coordination of submissions with NASSRA
Organize and prioritize work assignments
Work independently and closely with colleagues of various responsibilities and educational levels throughout the company
Initiate appropriate actions when individual decisions impact other aspects of the business
Review, approve, and track workflows and change controls
At least 10 years experience in a Biological regulated industry (i.e. GMP) with 3 years in RA
Experience in manufacturing or QA of biological products,
Experience with developing and obtaining regulatory approvals for biological products, biomedical hardware and software
Experience with IND, BLA submissions and updates/amendments to established licenses (PAS, CBE301) as well as working/communicating with health authorities (FDA, EU IVD, ISO)
Knowledge of US FDA and global registration requirements for biological products, IVDs and medical devices
Knowledge of US FDA Quality Systems regulations, ISO 9001, EN ISO 13485, and the EU IVD Directive
Must be able to think abstractly about data and be able to work with

Regulatory Affairs Manager Resume Examples & Samples

Essential Requirements
IEC 61010 Testing
Technical Files
In-depth knowledge and hands-on experience in developing and executing multinational global regulatory strategies in complex IVD system product development teams throughout product lifecycles
Developed, submitted and successfully obtained clearances for at least five FDA 510(k) submissions
Developed, submitted and successfully obtained approvals for at least five MDD or IVDD technical files
IVD Molecular Diagnostic submission experience a big plus
ISO 13485: 2003 or 2016 Medical Device Quality Management System Requirements
ISO 14971: 2012 Risk Management
FDA 21 CFR part 820 Quality System Regulations
IEC 62304 Medical Device Software – Software Life Cycle Processes
Medical Device Directive (MDD) or Vitro Diagnostic Directive (IVDD)
Experience managing at least 5 direct regulatory affairs reports a big plus
Resolution of FDA Class I Recalls a big plus
Resolution of FDA Warning Letter a big plus
Bachelor’s degree or higher in a related engineering and/or technical discipline. Master's Degree preferred
6+ years experience or equivalent combination of education and experience working in an FDA QSR and ISO 13485 regulated environment for a medical device manufacturer
Regulatory Affairs Certified (RAC) preferred

Global Regulatory Affairs Manager Resume Examples & Samples

Responsible for the compilation of relevant high quality documentation for submissions according to agreed schedules while taking into account regional specific requirements, as agreed with GRA-Regions
Supports the GRA-Regions in performing regulatory procedures as new license applications, renewals, change applications, PSUR/DSUR submissions and international Scientific Advice meetings
Provides regulatory support for CSL’s established products lifecycle plans; is responsible for the evaluation of change requests regarding global filing requirements in agreement with GRA-Regions and contributes to business case applications for new license applications as well as to the development and implementation of global regulatory strategies
Acts as the subject matter expert: e.g. interprets existing or new regulatory requirements as they relate to company products and projects and evaluates draft guidelines and writes impact assessments
Supports QA for Health Authority inspections
Provides technical guidance, organization and prioritization of the work of product scientists and/or specialists, as applicable
BS/BA/Masters Natural Science and preferably a degree in Regulatory Affairs
Excellent communication, project management, planning, problem solving and presentation skills
Flexibility to work in a global regulatory cross cultural work environment and to work independently as well as in a team
Demonstrated ability to develop constructive and effective relationships with peers and management

Global Regulatory Affairs Manager Resume Examples & Samples

Manage the global regulatory strategy for key compounds
Minimum MS degree (Ph.D. preferred) preferably in a regulatory science or related discipline (chemistry, toxicology, eco-toxicology, biochemistry or environmental science)
Experience in a regulatory – related role in chemical, pharma or plant protection industry (5+ years) with a global focus and demonstrated ability to apply scientific knowledge to regulatory related solutions
Basic knowledge of crop protection industry: technical, commercial, farming techniques, crop specific issues, etc. is preferred
Experience dealing with regulatory authorities and policymakers
Proven track record of successes in strategic thinking, operational excellence, communication and networking to drive results
Familiarity with risk assessment
Strong written and verbal communication skills, including the ability to synthesize data and develop recommendations
Ability to effectively monitor industry and regulatory activities and assess impact on key compounds
Strong problem-solving ability
Sound judgment, planning, project management and organizational skills

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Regulatory Affairs Manager Resume Examples & Samples

Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements
Manage submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings
May review, interpret, and report to the head of Regulatory Affairs on product specific regulatory issues that may have material impact on the business units, the corporation, or the customer. May work with the head of Regulatory Affairs to develop strategic and tactical responses to influence a reasonable regulatory environment
Responsible for adherence to departmental budget(s)
Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects
Interface with regulatory authorities on regulatory and technical matters, as appropriate
Manage the creation and review of Standard Operating Procedures and policy guidelines for the regulatory affairs department
Provide regulatory support on project teams
May serve as Functional Lead on Lifecycle or project team(s)
May perform other duties as required or assigned

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Regulatory Affairs Manager Resume Examples & Samples

Ensure that the Organization is in compliance with required Medical Device and IVD regulations; Develop regulatory strategies for NPIs and product registration maps
Site regulatory support – develop regulatory procedures, corporate and external audits, authority inspections, labels and docs review and approval; complaint investigation, regulatory knowledge sharing with the staff; AO import permits and goods customs clearance support. Build rapport with regulatory agencies and notified bodies as required, to perform effective and fast approvals for product registrations
Work closely with NPI Team to provide regulatory guidance for new product launch and registering them in various markets
Be responsible for product registrations and regulatory inspections/3rd party audits; act as a site regulatory lead by supporting QMS and ASEAN business
Monitor the regulatory development and trends in the region and report impact to the organization
Provide regulatory training to site staff, FSE/FAS, including QSR, local regulations, etc
Review labeling and promotional materials for regulatory compliance
Build rapport with regulatory authorities, RA counterparts within LT and external partners; Monitor the regulatory development and trends in the region and report impact to the organization
Ensure the business compliance with regional / global regulations / requirements; including FDA, HSA , CE IVD and advise management to take key business decisions keeping in view of local regulations and impact to the organization; participate in management reviews
Post market surveillance, reporting adverse events/recalls to the Authority; review labeling and promotional materials for regulatory compliance
Provide regulatory strategies/ registration support for registering Food Safety instruments, Animal Health (Veterinary diagnostics) within SEA region LSG SEA RA organizational leader

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Regulatory Affairs Manager Resume Examples & Samples

Overall responsibility for a specific client product with an expectation to build long term knowledge and become the product champion
Key member of client’s regulatory submissions management unit, working with the Programme Director and Manager to ensure client receives regular reports/updates as necessary
Lead a team of Regulatory Specialists to deliver global post-approval submissions
Liaise with internal/external stakeholders and experts to deliver quality submissions and ensure adherence to submission/approval work plan
Ensure Regulatory Submission Specialists have prescribed details to manage compilation of dossiers
LI-SH1

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Senior Regulatory Affairs Manager Resume Examples & Samples

To ensure that China proactively influences the Chinese regulatory environment, develops effective regulatory strategies and operational plans for new product registrations that meet business goals in an effective, timely and compliant manner
Develop and strengthen relationships with Chinese Regulatory agencies –CFDA, CDE, CFDI, NIFDC, Ch.P. etc
Drive the implementation of regulatory strategy and plans aligned with business goals in China
Partner with GEHC stakeholders to provide proactive regulatory advice and expertise on a global basis for core imaging products
Ensure effective dialogue between China RA and wider GEHC to ensure clarity of understanding and determine the most effective path to optimal regulatory approval
Ensure effective Regulatory Intelligence gathering, interpretation and dissemination to Global RA and R&D Colleagues to inform current and future China regulatory strategy and consequent impact on R&D support required
Be a core project team member on any R&D program developing new diagnostic products for China; work closely with the other core team members of project team
To ensure consistent and quality regulatory practices and compliance for core imaging products in China and that all Regulatory Affairs activities reflect both local commercial and global business priorities
Advanced degree in a Science discipline
Minimum 10 years’ experience in Regulatory Affairs within the pharmaceutical industry with minimum of 3 years new products registration experience. A considerable amount of this experience should have been gained in a senior role in the area relevant to their position
Demonstrated experience designing and implementing regulatory product strategy, interfacing with local and/or corresponding international regulatory bodies, including negotiation of pharmaceutical product approvals & lifecycle maintenance, resolution of issues and influencing/lobbying directly and through other external groups (e.g. trade associations)
Demonstrated understanding of the healthcare environment and knowledge of current competitive, commercial or political situations and their impact on regulatory strategies in China would be highly desirable
Demonstrated experience operating in a highly regulated environment. Proven application of analytical skills in a regulatory environment
Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English & Chinese, tailoring communication methods to customer’s requirements
Ability to influence at all levels of the company
Ability to work independently as required using sound judgment
Demonstrated ability to form, lead and manage cross-functional, cross-business teams
Demonstrated project management skills and the ability to prioritize, plan & evaluate deliverables to established strategic goals
Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research
Must be willing to travel as needed for key activities

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Regulatory Affairs Manager Resume Examples & Samples

Participates in the development policies and procedures to achieve specific goals
Works in a cross-functional team environment and a flexible team-oriented perspective
Prepare, assemble and submit regulatory submissions, such as Summary Technical Documents, Device Design Dossiers and other international regulatory submissions in various countries within the Latin American region
Provide input for regulatory requirements and regulatory strategies in interdepartmental meetings on product development to ensure timely submissions and approval. Determine product classifications, regulatory filing strategies and submission types. Participate in medical device product development teams and develop overall regulatory strategy that delivers on project costs, timeline and regulatory bodies approval (ANVISA, COFEPRIS, INVIMA, etc.) Ensure that project work proceeds according to agreed deadlines and maintain status records
Responsible for performing all duties in compliance with ISO13485, EU Directives FDA's Quality Systems Regulations and GMP's; and other applicable international regulatory requirements. The manager will also compile and/or review all regulatory agency submission materials to ensure timeliness, accuracy, completeness, and compliance with regulatory standards
Act as liaison for Company with regulatory agencies, as well as with other internal functional departments for new product submission strategy. Participate in regulatory agency inspections such as Pre-Approval Inspections, Quality System Inspections, and cGMP inspections, as necessary
Bachelor’s Degree in a scientific discipline or a related field is required. Advanced degree is preferred
Must be Bilingual - Spanish
5-8 years of experience in managing Regulatory Affairs for medical devices is required. High level of understanding of Drug, Biologics and Combination products regulations is a plus
Proven experience with preparation of regulatory submissions and demonstrated track record of successful regulatory approvals for medical devices and/or combination products in Latin American region is required
Proven experience with new product development, design controls, quality management system
Knowledge of FDA's Quality Systems Regulations, GMP's, ISO13485 and other ISO regulations/standards, including 10993, 14971 is necessary
Regulatory Affairs Certification (International) is preferred
Expertise in Microsoft Office applications is required, specifically Microsoft Word, Excel, Outlook, Project, PowerPoint

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Senior Regulatory Affairs Manager Resume Examples & Samples

Handles registration projects (CTA/NDA/BLA/other applications) for new product and global R&D development and/or maintain established products according to the regulations and registration plan
Actively involved in establishment and revision of regulations, guidelines and national drug standards
Handles crises related to regulatory affairs
A university degree major in chemistry, pharmaceutics, biology or a related life-science discipline. A master degree or above is preferable
At least 5 years of regulatory affair experience including 2 year in managerial role in a multinational pharmaceutical company
Strong lobby capability and excellent communication skill; excellent leadership with team spirit; high learning ability and willing to work under stress and face challenges
Fluent English in verbal and written; good computer skill.Regulatory Affairs

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Regulatory Affairs Manager Resume Examples & Samples

Represent regulatory on cross functional project teams, making regulatory decisions as required
Insure all consumer brands packaging is in compliance with federal, state and local regulations. This involves daily interactions with marketing, graphic design, sourcing and outside design agencies to insure that all existing, new and revised packaging graphics and placements are in compliance with labeling regulations. This can include writing label copy and will include proofing artwork. This interaction is required from the beginning of the design process to review of final art work prior to package production
Support commercialization process and ensure timely execution of regulatory related tasks– including co-packer and self-manufactured product label copy review, maintenance of Checklists, Consumer Brands Style Guide and SOPs
Facilitate content management for regulatory systems (Genesis, Repositrak, Smart Label), ensuring accurate information and process are maintained in the systems
Formal course work or seminars on Food Regulations
College degree a plus
Minimum 3 years of documents and data management
Strong personnel and project management skills
Management background is critical to this position as the incumbent will be required to manage all daily activities associated with this role
The incumbent will be required to work with product development on formulation requirements, marketing and graphics design personnel on package graphics
The incumbent must be able to think both strategically and tactically and have experience in project management, multi-tasking, meeting tight deadlines and shifting work focus based on shifting business and technical priorities
Excellent computer skills and experience with online specification systems. Strong communication skills both oral and written

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Senior Regulatory Affairs Manager Resume Examples & Samples

Demonstrated practical experience working directly with regulatory agencies, preferably including both FDA and European notified bodies
Experience working on global regulatory submissions for combination products
Good working knowledge of clinical trial design and data analysis
Demonstrated knowledge of global medical device regulations & overall regulatory environment
Track-record of improving regulatory or cross-functional business systems and processes
Demonstrated supervisory and interpersonal skills

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Regulatory Affairs Manager Resume Examples & Samples

Coordination, Evaluation, preparation & submission of regulatory documents
Regulatory Intelligence and updating changes in the local regulations. Assess the impact on business operations
Good management of databases and their regular update
Maintenance and regulatory compliance of the GSK portfolio, including the updating of packaging items
Crisis management and product incident
Promotional Material review and approval

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Regulatory Affairs Manager Resume Examples & Samples

Determining effective regulatory pathways for a variety of products types
Participate in cross-functional teams to implement the regulatory strategies for the timely support of project team goals
Ensure that product development projects and changes to existing products are conducted in compliance with the appropriate regulations
Prepare Pre- IDE, 510(k), CE Mark Technical File and other related regulatory filings- US and International. Provide leadership and ensure the timely and accurate filing of regulatory documentation
Interface with FDA, Notified Bodies, and other international regulatory agencies regarding regulatory submission strategy and approval reviews
Collaborate with R&D and MASA to determine and execute pre-clinical test plans in support of regulatory submissions,
Maintain current knowledge of competitive technologies in addition to medical and technical developments related to the company's products

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Senior Regulatory Affairs Manager Resume Examples & Samples

Scan the external environment and work with external associations & global regulatory bodies, proactively adapt regulatory strategies, and influence change within areas of responsibility
Identify global regulatory trends & their implications for GE Healthcare, taking into consideration the impact on business decisions
Analyze & communicate proposed, new or changing requirements and standards, & lead teams to develop strategies, programs and processes to meet business objectives and ensure compliance with regulatory requirements
Communicate with regulatory authorities within areas of responsibility
Evaluate performance metrics to identify program weaknesses & drive improvements in procedures or oversight
Educate, train, advise & coach company professionals to ensure compliance with RA requirements
Work across GEHC to ensure a consistent approach to regulations is adopted throughout the business within areas of responsibility
Lead & support continuous improvement activities with regard to areas of responsibility
Recruit, mentor, coach and train direct and indirect reports on activities within area of responsibility
Bachelor’s Degree & minimum of 10 years experience in the medical device or pharmaceutical industry or medical product regulatory agencies; OR minimum of 14 years progressive regulatory affairs experience in medical device or pharmaceutical industry or medical product regulatory agencies, including knowledge & experience applying drug or device laws & regulations for product registration, adverse event reporting, & recalls
At least 2 years leadership experience, including training and coaching of team members
Demonstrated ability to lead cross-functional, cross-business teams
Demonstrated knowledge of regulatory issues and experience interfacing with local & internationals regulatory bodies, such as FDA, European competent authorities & notified bodies, Health Canada, SFDA, KFDA, MHLW, etc
Ability to prioritize, plan, delegate and evaluate deliverables to established strategic goals
Demonstrated experience operating in a highly regulated environment; Proven application of analytical skills in a regulatory environment
Strong problem solving and negotiation skills with the ability to develop and implement complex influencing and negotiating strategies that demonstrate political awareness
Ability to work well independently and in a team setting
Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements
Ability to influence and make recommendations at all levels of the company
Experience using spreadsheet and presentation software
Must be willing to travel up to 15% of time
Advanced degree in scientific, technology or legal disciplines
Regulatory Affairs Certification (RAPS)
Knowledge of Quality Management Systems
Experience working across cultures/countries/sites
Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment
Demonstrated ability to drive change, challenge the status quo and champion new activities, stimulating others to change and manage implementation effectively
Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies

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Regulatory Affairs Manager Resume Examples & Samples

Scientific Degree and demonstrated experience in a similar role
Regulatory principles
Knowledge of and experience in regional regulatory environment
Communication skills - both oral and written
Ability to anticipate and prevent potential issues
Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
MSc/PhD in Life Sciences
Experience interacting with regulatory agencies
Cultural awareness and sensitivity to achieve results across both regional country and International borders

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Regulatory Affairs Manager Resume Examples & Samples

Receive and archive all ‘CMC, PT & Update’ that are dispatched by Regulatory team in Hyderabad
Prepare and submit the ‘CMC, PT & Update’ that are relevant to assigned countries
Ensure speedy approvals from Health Authorities in assigned countries
Ensure implementation of the CMC/PT and updates with no supply interruption in close collaboration with the supply chain manager for the assigned country (ies)
Coordinate with maintenance group - Team Leader to ensure correct and speedy implementation / correct consignments
Ensure new/renewal of registration of manufacturing site as per new and mature products registration plan in the assigned countries
Ensure speedy submissions and approvals of manufacturing site registration in the assigned countries in order to shorten time of product registration
Update local archives for manufacturing site new/renewal of registrations
Ensure implementation with no supply issues in close collaboration with the supply chain manager of the assigned country
Coordinate any pricing impact for the ST with finance/ and MA managers in the assigned country ( ies)
Provide necessary supports to the responsible parties of the acquired products and establish proper strategy of submission/approval of the transfer
Provide necessary maintenances (CMC/PT/Renewals) to the transferred products products until the transfer process is completed in coordination with the internal and external stakeholders
Coordinate properly with the supply chain, commercial team to ensure proper implementation of the ytransfer with no supply issues
Developing and maintaining Healthy professional relationships with MOHs in assigned countries
Design and implement Health Authority management plan
Effective identification and communication of regulatory changes and emerging opportunities in assigned countries
Ensure transparency in Health Authority communication and interaction
Ensure participation at relevant local trade association

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Regulatory Affairs Manager Resume Examples & Samples

LI-ST1
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience
1 year of leadership responsibility
English language as well as local language where applicable
Familiar with computers and their applications, e.g. Word, Excel, PowerPoint
Good organizational and planning skills
Good knowledge of global / regional / national country requirements / Regulatory Affairs Procedures for Clinical Trial Authorization, licensing, lifecycle management
Ability to act as liaison with other departments where necessary (i.e. Project Management, Clinical Supplies, QA, Clinical Management, Data Management, Biostatistics, etc)
Mental skills required in areas of: numeracy, language, analytical, investigative, verbal & written communication, customer contact, attention to detail, multiple project handling, reading and interpretation of data

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Regulatory Affairs Manager Resume Examples & Samples

Ensure products within scope (inc medicines, devices, cosmetics and foods) can be placed on the market with optimal yet compliant claims, advertising and promotion in line with commercial plans
Ensure products are maintained and meet internal and external compliance requirements
Be a productive part of defined local regulatory team, including being a proactive partner to other stakeholders, eg, area regulatory team, marketing/sales within local commercial business, supply chain and quality etc. Lead a team of regulatory professionals if required
Ensure products within scope (inc medicines, devices, cosmetics and foods) are maintained with optimal yet compliant claims, advertising and promotion in line with commercial plans and relevant technical updates in collaboration with Area marketing and relevant teams
Engage with the external regulatory environment within defined area of responsibility and act as a responsible voice of GSK CH with local regulators, trade associations and other key external regulatory bodies
Work together with regulatory colleagues and other stakeholders to proactively look for opportunities and solutions to challenges, including leading implementation of improvement initiatives
Provide input into regulatory strategies and process improvement/compliance activities within defined areas of scope
Lead preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market
Analyse regulatory issues and communicate effectively with key stakeholders, including global colleagues. Lead development of strategies and plans to mitigate, so that we can deliver products backed by science that are robust and aligned with business needs
Actively contribute to high performing teams, including looking for ways to improve performance. May lead direct reports or cross-functional teams within local market
Build relationships with key stakeholders and represent GSK in a responsible manner according to company values, in order to communicate GSK CH policies and strategies and negotiate outcomes
Manage compliance within defined portfolio/activity streams in line with GSK CH expections - support key processes and ways of working (eg, in relation to GSK CMC, quality, product labeling requirements as well as local MoH regulations). Propose solutions to identified issues and implement
Collaborative working together with other functions ( eg, marketing, supply chain) to deliver agreed NPD and value engineering projects
Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated
Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business
Maintain required regulatory compliance databases, systems and processes. Train other compnay stakeholders as required to build knowledge and compliant utilisation
Maintain high level of knowledge on the science of products within defined portfolio
The role is accountable for the preparation and delivery of regulatory activities and outcomes across a range of areas, including sign off and execution of all regulatory interfaces in the market. This includes Ministries of Health (filings and meetings), Trade Associations, Advertising review bodies etc.. All product classifications are in scope, whether known (drugs, cosmetics, devices, foods) or potentially new (e.g. digital apps, biocides, botanicals, biologics)
The position reports to the local regulatory lead ( or potentially to an area lead ), and is also accountable to support local commercial teams as a partner to deliver projects and strategies. The role may also lead locally based regulatory staff
The role needs to be keep up to date with relevant science and regulations within defined portfolio in order to effectively deliver NPD and support base business

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Regulatory Affairs Manager Resume Examples & Samples

Ensure products within scope (inc medicines, complementary medicines, devices, cosmetics and foods) are compliant from an OPAL and regulatory tracking perspective and can be placed on the market with optimal yet compliant claims, advertising and promotion in line with commercial plans
Be a productive part of defined area regulatory team, including being a proactive partner to other stakeholders, eg, local regulatory team, marketing/sales within local commercial business, supply chain and quality etc
Develop, implement and manage GMS governance processes (including compliance, non-conformances and deviations)
Support GMS with investigating and evaluating the regulatory impact for all non-conformances and deviations
Liaise with GMS and other portfolio managers to ensure compliance and resolution of non-conformance
Support GMS with regulatory authority audits i.e. MCC, MHRA, other Africa regulatory authorities
Be the Regulatory champion with GMS ensuring capability building with the GMS Quality team to ensure alignment to the needs to regulatory guidelines and regulations
Support the GMS QMS for any regulatory requirements
Tracking of change controls involving regulatory input and closure. E2E process
Manage preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market
Develop and manage the Southern Africa Regulatory KPI’s and Dashboard
Ensure optimal Regulatory Compliance levels for Southern Africa
Communicate with key area stakeholders highlighting any regulatory issues, and develop plans to mitigate at concept stage by ensuring open and transparent communication with the markets so that we can deliver science that is robust and aligned with business needs
Build relationships with key stakeholders and represent GSK in an appropriate manner according to company values, in order to present GSK CH policies and strategies
Work together with other functions (e.g. marketing, supply chain, GMS) to deliver NPD and value engineering projects
Proactively manage the impact of regulatory changes on the business with the Area Director
Create/track metrics/dashboards (RFT dossiers/dispatch to file dates/approvals/launches) for the Southern Africa area
Maintain required regulatory compliance databases, systems and processes
Embed a framework in-place to measure and track Regulatory Affairs (RA) performance quality processes
Ensure Area visibility at all times of database systems’ content, ensure data maintenance activities are performed in line with high GMP standards, updates made accurately & in a timely manner (Responsible to Run regular checks on OPAL and report back to prime & secondary stakeholders adherence levels)Lead preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market
Champion the Labelling compliance initiatives in Southern Africa ensuring an E2E compliant process
Liaise with central Labeling on GLC approvals (i.e. a “heads up” to markets in advance of GDS dispatch)
Monitor CLDs (L1)
Ideally a minimum of 8-10 years experience in Regulatory Affairs, however this will vary between markets depending on availability of regulatory talent. Experience with working with manufacturing facility will be advantageous
The role is accountable for the preparation and delivery of regulatory activities and outcomes across a range of areas, including sign off and execution of all regulatory interfaces in the market. This includes Ministries of Health (filings and meetings), Trade Associations, Advertising review bodies etc.. Various product classifications are in scope, whether known (medicines, CAMS, foods) or potentially new (e.g. digital apps, biocides, botanicals, biologics)
The position reports to the Senior Regulatory Affairs Manager local regulatory lead ( or potentially to an area lead ), and is also accountable to support local commercial teams as a partner to deliver projects and strategies. The role may also lead locally based regulatory staff

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Regulatory Affairs Manager Resume Examples & Samples

Previous experience in regulatory affairs
Higher education (pharma, biological, chemical)
Attentive to details, independent
Proactive, result-oriented
English (strong Intermediate and higher)Regulatory Affairs

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Regulatory Affairs Manager Resume Examples & Samples

Oversee and review the preparation of M2 and 3 CMC components of filings
Accountable for management of regional CMC filings from marketing authorisation to post-approval supplements, renewals and responses to questions across assigned products and countries
Gathering, consolidating and analysing regulatory intelligence for Intercontinental region and support its application to product-specific activities
Provides guidance for regulatory assessments of change control requests
Provide regional/country, product & regulatory expertise and clarification on regional CMC RA requirements
In-depth experience of pharmaceutical/biotechnology or medical device industry
Strong record of related experience within Regulatory Affairs (min 5 years)
Strong communication skills - oral and written Organizational skills
Ability to develop solutions to technical and organizational issues in order to improve performance and productivity
Strong computer skills, including word processing, database document repository and project management software
Strong team player with a commitment to customer service
Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect
Time and project management skills
Drive for results
CMC- specific regulatory knowledge & experience within biotechnology
Direct experience with EU and EM market applications – MAAs or variations
Good understanding and direct experience of ex US filings
Creation and execution of regional regulatory strategies – MAAs or variations
Management of intelligence
Expanding knowledge of related disciplinary areas
Understands the core business process and purpose of the functional area in Amgen’s commercialization process
Developing own project management techniques
Enhances own knowledge through understanding business trends and objectives
Current knowledge and application of CMC hot topics and knowledge of EU/EM legislation and guidance for biotechnology products
BS (MS or higher preferred) life sciences, engineering or related field

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Regulatory Affairs Manager Resume Examples & Samples

Write and submit – ANDA submissions (initial, amendments, supplements, annual reports); drug master files (initial, amendments, annual reports); plant/site master files; licenses, permits, and registrations to meet FDA, DEA, and FL DOH requirements, including Establishment and Drug Listing with FDA; other submissions as required
Serve as Regulatory Subject Matter Expert to guide Catalent sites on chemistry related issues, including but not limited to the CMC requirements for US INDs, US ANDAs, and US NDAs throughout the product lifecycle; contracts; production; and validation. Use expertise to help sites navigate requirements for world-wide product registrations. Address CMC regulatory issues both within Catalent, and with Catalent customers. Review chemistry-related documentation for consistency, logic and anticipate possible problems. Assist other sites in navigating regulatory websites to locate regulatory information
Assist customers and other Catalent sites in preparing accurate submissions and responses to the FDA and foreign regulatory authorities as these pertain to the chemistry and manufacture of soft gelatin capsules
Work with Validation, Quality Control, Quality Assurance, Research and Development and other departments to ensure quality-starting materials, products, manufacturing validation and product chemical stability
Prepare standard operating procedures (SOPs) for CMC/regulatory procedures pertaining to Marketing Authorizations, and support thereof; DEA requirements; and FL DOH requirements
Work with the Federal Drug Enforcement Administration (DEA) to insure that Catalent is complying with regulations for scheduled and listed drugs
Provide oversight and guidance to the site regarding all DEA matters pertaining to controlled substances and Listed Chemical registrations; quotas; security of and access to DEA storage areas; inventories and inventory reports required by DEA, including initial inventories, biennial inventories, YERS reporting, ARCOS reporting; import and export permits and declarations
3 years experience preparing strategic plans for Regulatory Affairs
5 years experience applying US Federal Regulations to New Drug Applications, Abbreviated New Drug Applications and OTC products, including preparing and submitting such applications throughout the product lifecycle (initial; amendments; supplements, especially experience with post-approval submission requirements, annual reports). Experience with electronic filings, especially e-CTD format, a plus
5 years experience in preparing and submitting both plant/site and drug master files, including working and communicating directly with regulatory agencies
5 years experience in preparing and submitting drug annual reports, drug listing submissions, and labeling submissions per the Code of Federal Regulations, including working and communicating directly with regulatory agencies
5 years experience with pharmaceutical good manufacturing practices
5 years experience working with international regulatory requirements, including but not limited to regulations for the EU, Canada, TGA, PIC/S, etc
3 years experience in facilitating post-marketing safety reports is desirable
3 years experience in working with fulfilling requirements associated with controlled substances and listed chemicals

119

Regulatory Affairs Manager CNV Resume Examples & Samples

Directs and coordinates activities concerned with the submission and approval products to government regulatory agencies
Develop world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products
Provides guidance to project team members regarding regulatory and compliance issues by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities
Oversees the preparation and maintenance of regulatory submissions and files including but not limited to 510(k)'s, IDE/IDE Supplements, PMA/PMA Supplements, HDE/HDE Supplements, Annual Reports, Design Dossiers/Change Notifications, and Technical Files for a diverse range of neurovascular products, including Class III devices
Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new devices and regulatory support of marketed devices
Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters
Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals
Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations
This role leverages scientific and technical understanding of medical devices to serve as a resource and strategic partner for development and planning throughout the product lifecycle in applicable markets
Builds, sustains, and rewards a culture of innovative thinking, informed risk taking, intellectual curiosity, and the continual learning of scientific, technological, and Regulatory developments
Advises and challenges others, including cross functional business partners, to ensure the best business-level best decisions are consistently made within the organization and based on the Credo
Excellent written, verbal communication and presentation skills are required
Tactical and strategic regulatory and business knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class III devices (US and EU) is required
The ability to partner and influence key stakeholders on NPD and Lifecycle teams is required
Ability to work as a member of a team in a timeline-driven environment with limited supervision is required
The ability to cultivate external relationships with regulators in key markets (in partnership with Regions, Policy and EU Strategy leads) and internally collaborating with the R&D, Med Affairs, Clinical Affairs, GSM and other partners is required
The ability and experience to anticipate regulatory changes in key markets to maximize patient access to innovative technologies is highly desired

120

Regulatory Affairs Manager Resume Examples & Samples

Understanding of local regulatory activities and how they affect projects and processes
Ability to input effectively on multi functional teams
Regulatory knowledge for assigned country and/or region
Understanding of regulatory activities and their touch points

121

Regulatory Affairs Manager, Biotechnology Resume Examples & Samples

Ability to multitask and manage multiple deadlines competently
Ability to raise risks and propose mitigations
Ability to work independently with minimal management
Team player with excellent interpersonal and communication skills
Excellent prioritizing, organizational, and interpersonal skills

122

Seeds Regulatory Affairs Manager EU Resume Examples & Samples

Secure registration, in a timely manner per business strategy, for the vegetable variety pipeline
Champion implementation and maintenance of dedicated processes and tools to secure Operational Excellence in the activities dedicated to variety registration
Develop and maintain expertise on regulatory requirements related to seed movements and seed marketing especially in the areas of phyto-sanitary and seed labeling
Establish and maintain relations with relevant Official Examination Offices
If required, get engaged in experts group with the Dutch Seed Association or Dutch Examination Office (NAKT)
Contribute to Issues management and incident response when required
Education: Master degree, preferably in plant sciences or related experience
Work Experience: Relevant experience in the seed industry, plant variety registration, plant breeding, phyto-sanitary matter
Working level of Dutch & English language
Special Skills: Highly developed organizational skills; attention to procedure and detail; a proven ability to deliver results in a multi-disciplinary, team-based working environment; leadership
Knowledge: EU Seed rules and regulations, basic knowledge in plant biology

123

Regulatory Affairs Manager Americas Resume Examples & Samples

Minimum 7 years work experience in regulatory affairs for a chemical company
Experience with US TSCA
Strong analytical, organizational, reporting, presentation, and oral and written communication skills
Proven track record of managing high-performing teams, prioritizing, and meeting established deadlines
Experiencing managing successful cross-functional projects to completion

124

Regulatory Affairs Manager, Asia Resume Examples & Samples

Serving as an integral member of the International Global Stewardship team supporting product regulatory compliance for goods imported and/or sold in Asia
Ensuring compliance for a broad portfolio of household or consumer packaged goods
Acting as primary Regulatory Affairs representative for Asia, developing robust relationships with cross-functional teams (e.g., R&D, Legal, Quality, Supply Chain), regulatory experts, governmental agencies and relevant industry associations
Serving as an integral member of the Business Team advising and collaborating on all regulatory/compliance related matters within the region
Participating on Product Development teams providing overall regulatory guidance towards execution
Monitoring and communicating existing and changing regulations, as well as their impact to our business
Developing and implementing a variety of regulatory and/or compliance strategies to provide competitive advantage
Ensuring compliance with product and/or facility registrations, chemical reporting regulations
Reviewing product labels, Marketing Communications and product claims
Managing regulatory budget for Asia
Successful management of third parties
Extensive experience working with regulated products within FMCG/CPG global organisations, including chemical reporting
Demonstrated ability to effectively interface with regulators, cross-functional teams and regulatory colleagues
Strong analytical skills reviewing and implementing regulations
Experience working government agencies, industry associations and 3rd party service providers
Working knowledge of relevant regulations for the region, including REACh, GHS and others
Ability to effectively work within a remote-based team environment
Strong interpersonal and communication skills and an independent, self-starter
Strong leadership skills, well organized and able to handle a wide variety of tasks with ease
Strategic thinker with ability to translate into actionable plans
Resourceful and ability to develop Company positions and advocate
Creative problem solving and strong process orientation
Willingness to travel within the region
BS in Chemistry, Chemical Engineering, Food Science or equivalent
Fluent Mandarin speaker and strong English language skills essential
Cantonese speaker desirable

125

Regulatory Affairs Manager Resume Examples & Samples

Diploma or Degree in Banking or Finance
5 years of working experience in banking in the Compliance function
Good communication, interpersonal and relationship skills
Good numeracy skills and accuracy
Good personal organisation skills
Will be required to work flexibly across a range of processes and activities at a similar level
Good report writing skills
Analytical skills and manipulation of data

126

Regulatory & Regulatory Affairs Manager Resume Examples & Samples

To govern the product registrations and the regulatory affairs area to ensure that the company has the appropriate regulatory approvals required to operate and deliver it’s business objectives
To work closely with external relationships with key players in order to maximise their support
To manage and lead all Regulatory work in Crop Protection and Seed product registrations and the Regulatory team
To anticipate proactively local regulatory issues to ensure delivery of Commercial Unit and EAME business objectives
To take responsibility for regulatory related standards and compliance
To work closely with the relevant internal and external stakeholders to ensure about the implementation of the regulatory and stewardship strategy on national level
5 to 10 years of experience, ideally with a PhD in Life Sciences, experience in the crop protection regulatory area with the knowledge of national regulation and understand the impact of European Union legislation
Good knowledge of local Agrochemical market and CP, Seed products
Understanding crop programs and general agricultural technical background
Good relationships with key official bodies
High level of computer literacy
Advanced English (written and spoken)
Excellent local language skills are critical
Analytical and strategic thinking with planning and implementation ability

127

Regulatory Affairs Manager, Malaysia Resume Examples & Samples

Bachelor’s Degree in Pharmacy and must be a licensed pharmacist holder
Strong communication skills – both oral and written
Experience in regulatory documentation required to support regulatory submissions

128

Regulatory Affairs Manager, Launch Resume Examples & Samples

Launch preparation
Identify and implement appropriate Nordic regulatory strategies
RA Business Partnering
Expert on regulatory requirements
Ensure timely launches in close cooperation with Launch management, QA and Supply Chain
Close collaboration with Regulatory Competence Center EU for planning of new submissions/variations
Prepare and ensure timely submission of national texts for new submissions/variations
Provide pro-active business partnering
Provide regulatory strategies
Text management in accordance with current guidelines including preparation, proof reading and release for print
Negotiation with business partners/regulatory authorities
Keeping updated on EU and national legislation in each of the Nordic countries
MSc in Pharmacy or Master’s degree in life sciences
3-5 years of professional expertise within regulatory affairs
Extensive knowledge of national and EU regulatory guidelines and legislation
Fluent in English. Languages skills within one or more Nordic country languages are an advantage

129

Regulatory Affairs Manager Resume Examples & Samples

Ensure that teams are adequately resourced, motivated and skilled to support the Regulatory function
Make sure that RA team knows and applies global processes & systems
Provide clear standard/expectations for performances and offers support through knowledge sharing and cooperation

130

Regulatory Affairs Manager Resume Examples & Samples

Preparation of regulatory submissions, maintenance of registered products and providing input to regulatory strategies, and compliance to major international regulatory standards
Interface and coordinate with CFDA during inspection or other government agency audits as required
Interpret existing and/or new regulatory requirements as they relate to company products and procedures
Assure all marketing, sales and other materials (e.g. labels) and practices are in conformance with regulatory requirements
Monitor regulatory activities for the region and implement strategies for regulatory efficacies
Liaise with regulatory bodies, internal QA, Operations, commercial and distributors to understand market trends and regulatory compliance dynamics
Managing compliance of products in accordance with existing regulations and guidelines
Other works assigned by AP QA/RA Director

131

Regulatory Affairs Manager Resume Examples & Samples

Responsible for managing and implementing EU regulatory strategies in support of assigned projects and sub-teams for centrally approved orphan medicinal products and products currently in clinical development
Working closing with the regulatory sub-team and cross-functional stakeholders
For products in development, primary responsibilities will involve planning, preparation and submission support for EU clinical trial applications, scientific advice procedures, orphan designation requests, and Pediatric Investigation Plans (PIPs)
For marketed products, responsibilities will involve planning, preparation and submission of MAA variations, Renewal documents, post-marketing commitment submissions, PSURs and other ad hoc activities in support of maintaining the marketing authorizations
B.S. and 6+ years of Regulatory work experience
Experience preparing, submitting, and working closely with EMA

132

Regulatory Affairs Manager Resume Examples & Samples

1) Education level required
Degree in a Life Science program
Master or Post graduation degree
2) Years of Experience
Minimum of 8 years of medical device, diagnostic or related industry experience
2 years of direct management experience
3) Required knowledge
Solid knowledge of regulatory requirements in Wave 3 markets in LATAM: Peru, Ecuador, Uruguay Central America and Venezuela
4) Required skills
Ability to articulate country requirements to multiple audiences and to translate regulations into clear data requirements to support registrations
Highly skilled in establishing partnerships with regional colleagues in a highly matrix environment
Demonstrated strong leadership, organizational, and planning skills with the ability to work cross-functionally with a diverse work force and customer base
A strong results-orientation and sense of urgency whilst demonstrating proficiency and success in prioritizing and handling multiple projects simultaneously
Must be able to communicate clearly, succinctly and effectively over the phone and in writing in English
Maintain the highest levels of professionalism, ethics and compliance at all times
Diligently participate in our compliance program-related activities as denoted by the supervisor or our Chief Compliance Officer
5) Required Experience
Multi country experience desirable
Relationship building, negotiation and a proven track record of strategic thinking
Working on industry working groups or cross J&J experience
6) Language: Fluency in English and Spanish is required
7) Certifications: RAC and MBA desirable
8) Travel percentage: 25% of International travels
9) Location of the role: Preferred Peru, but possible location in other LATAM countryRegulatory Affairs

133

Regulatory Affairs Manager Resume Examples & Samples

Serves as the primary resource for business segment(s) regarding global chemical regulatory requirements including hazard communication requirements, regulatory requirements, and responding to customer inquiries
Monitors global chemical control regulations and assesses impact on company products to assure compliance
Maintains expert knowledge of product regulations and requirements through extensive reading and consultation with both internal and external experts and regulators. Interacts with others to share scientific knowledge / interpretation and provide technical advice and consultation to ensure compliance with applicable requirements
Develops and implements methods of communicating and updating Cabot employees regarding product laws and regulations. Develops and delivers training as needed to ensure understanding of regulations
Provides input on communications related to product regulatory issues to customers, suppliers, distributors and regulatory agencies when needed
Works with business functions to integrate product compliance during all phases of product development and commercialization
Monitors and manages emerging issues in the areas of product safety and chemical regulation
Represents company interests in trade groups as assigned
Supports efforts to implement and maintain the Responsible Care® Management System in line with the requirements of the RC14001® technical specification, as applicable to the site/region

134

Regulatory Affairs Manager Resume Examples & Samples

Must have 5 years experience working in a Regulatory Environment preparing submissions for complex devices or other product categories and a successful track record
Must have 1-2 years direct management experience
Experience in working on industry working groups or cross J&J experience
A Bachelor’s Degree in Engineering, Pharmacy or other life science: Can be a person with related experience and/or training or equivalent combination of education and experience. Advanced Degree preferred. Bi-lingual: English – Portuguese
Advanced computer skillsRegulatory Affairs

135

Regulatory Affairs Manager, Device Team Resume Examples & Samples

1) Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
2) Represent or lead the RA function on assigned cross-functional project teams 3) Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
4) Establish appropriate communication within RA and other functions primarily at project level
5) Perform gap analysis and propose solutions
6) Develop and document sound regulatory decisions and justifications
7) Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
8) May provide direct supervision of individuals
9) May review promotional material or SOPs for compliance with local and global regulations
1) Sound basis of Regulatory knowledge
2) Scientific Knowledge
3) Ability to manage complex projects and timelines in a matrix team environment
4) Strong oral and written communication and presentation skills
5) Demonstrated interpersonal skills including strong negotiation skills
6) Ability to independently identify compliance risks and escalate when necessary
7) Ability to lead and coach others
8) Bachelors degree or country equivalent in related scientific discipline; Higher degree/PhD will be an advantage
9) Minimum of 5 years regulatory experience in RA with experience in PMA/IDE submissions and direct FDA interactions, including managing people or projects

136

Regulatory Affairs Manager Resume Examples & Samples

Responsible for developing a global product regulatory strategy for surgical devices
Liaise with global regulatory counterparts to ensure regional requirements are incorporated into product strategy development
Develop a product regulatory timeline aligned to Bausch & Lomb's product development, with key regulatory milestone, and activities for agency filing
Coordinate with the team on the development of product labels
Coordinate with key partners and regional counterparts to ensure timely and accurate submissions to Regulatory authorities
Liaise with Bausch & Lomb country-specific surgical Regulatory Affairs personnel for international submissions and registrations
Manage assigned personnel
Other job responsibilities as needed
8+ years relevant medical device industry and regulatory experience
Ophthalmic Surgical device regulatory experience highly preferred
Bachelor’s degree in science or health related field
Advanced degree preferred (PhD, MD, MS, Pharm, or equivalent)

137

Regulatory Affairs Manager Resume Examples & Samples

Support the delivery of the Assurance regulatory strategy, including its reputational positioning among regulators, policy-makers and investors
Monitor, analyse and report relevant emerging regulatory changes and/or developments to ensure the firm understands the changing environment in which EY UK operates
Able to build relationships and influence key internal and external stakeholders on topical industry issues
Contribute to the development of publications and White Papers working with the Director of Regulatory & Public Policy to deliver evidence-based materials for clients
Horizon scanning – keeping in touch with internal and external developments and networks to ensure new or emerging issues are picked up
Provide individual or collective support to the Regulatory Affairs Analysts, including coaching, mentoring and sharing experience
Leveraging the team’s collective knowledge, skills and expertise to produce credible, high quality outputs, including written and oral briefings
Proven ability to assess and analyse complex policy issues, making sound judgements/decisions with confidence with the flexibility to change priorities when required
Excellent written and oral communication skills, including the ability to

138

Regulatory Affairs Manager Resume Examples & Samples

Implementing Area & Affiliate regulatory strategies & deliverables for development compounds and marketed products
Interfacing with local Affiliates to manage submissions appropriately
Interface with Commercial to provide advice and guidance as appropriate
Proactively managing the labelling and other maintenance activities across the region
Managing CMC activities for assigned products across the region
Degree level education or equivalent - in a life sciences discipline
Previous experience in pharmaceutical Regulatory Affairs
Previous above country / regional experience - ideally in the EEMEA region
Experience working effectively across cultures and in a complex matrix environment
Proven experience of working effectively with commercial parts of the organisation
Strong planning, organising and project management skills
Confidently build relationships with stakeholders across regulatory affairs and functions of the business
Anticipate regulatory risks and proactively develop potential solutions
Take the initiative, are eager to learn and to deliver results
Are a good communicator, are tenacious and highly determined
Build relationships widely, make high quality decisions, are patient focused
Manage concepts through to reality, anticipate the future and seize opportunities

139

Regulatory Affairs Manager Resume Examples & Samples

1) Provide expertise in regulatory affairs leading to the successful regulatory registrations and approvals of Companion Diagnostic products in global markets
2) With Regulatory Sr. Management, develops regulatory strategies related to CDx product development
3) Provides regulatory assessments and plans for international product registrations and approvals
4)Interacts and collaborates with pharmaceutical partners in joint meetings
5)Ensures the accurate and timely preparation of regulatory submissions and reporting in accordance with Company goals, regulatory requirements and partnership contracts
6)Works across the Agilent organization to ensure alignment of regulatory processes, standards and compliance. Provide expertise and advice in obtaining CDx product registrations and approvals in the Pacific Asian market
7) Represents the Company in 3rd party meetings, especially the FDA, and regulatory associations
8) Stays abreast of global IVD regulations and guidances, especially those relevant to Companion Diagnostics

140

Regulatory Affairs Manager Resume Examples & Samples

Communication with the authority (Swissmedic) and the head office
Marketing Authorization Applications for new products
Orphan Drug Applications
Development of regulatory strategies for new products and the timely provision of documents for Swissmedic in collaboration with the Senior Regulatory Affairs Manager
Continuous maintenance of marketing authorizations for all medicinal products (Life-Cycle Management)
Preparation and submission of variations concerning the approved products (Quality-, Labelling changes,…)
Safety submissions, e.g. Periodic Safety Update Report (PSUR)
Provision of packaging material: revision, translation, proofreading and publication of professional and patient information
Continuous updating of the product information to be in line with the current CCDS
Ensure high quality professional communication when responding to medical inquiries
Set-up standardized answers for FAQ (frequently asked questions) or routine requests in collaboration with medical advisors and medical science liaisons
Support in creation and maintenance of promotional materials
Review of promotional materials and their monitoring for conformity and compliance with regulatory requirements
Pharmacist or life science degree
German (must), English (must), French good knowledge
MS-Office
LI-RL1-EUR

141

Scientific Regulatory Affairs Manager Resume Examples & Samples

Master’s degree in Food Science or Nutrition or related science background
Minimum of 8 - 10 years product compliance, commercialization and innovation in the food, beverage or pharmaceutical industry
Ability to work in multi-lingual environment
Work across multiple and distributed locations
Ability to travel @40% for this role

142

Regulatory Affairs Manager, Cardic Assays Resume Examples & Samples

Develop new regulatory policies; processes and SOPs and train key personnel on them
Evaluate regulatory risks of division policies; processes; procedures
Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
Assist in regulatory due diligence for potential and new acquisitions
Utilize technical regulatory skills to propose strategies on complex issues
Determine submission and approval requirements
Identify emerging issues
Monitor trade association positions for impact on company products
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
Recruit; develop and mentor regulatory professionals
Assess the acceptability of quality; preclinical and clinical documentation for submission filing
Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
Compile; prepare; review and submit regulatory submission to authorities
Monitor applications under regulatory review
Communicate application progress to internal stakeholders
Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities
Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies
Provide strategic input and technical guidance on regulatory requirements to development teams
Manage and execute preapproval compliance activities
Oversee processes involved with maintaining annual licenses; registrations; listings and patent information
Ensure compliance with product postmarketing approval requirements
Ensure external communications meet regulations
Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events
Actively contribute to the development and functioning of the crisis/issue management program
Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies
Report adverse events to regulatory agencies and internal stakeholders
2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 4-5 years’ of experience in a regulated industry (e.g., medical products, nutritionals)
2+ years of experience with IVD Cardiac assays

143

Regulatory Affairs Manager Resume Examples & Samples

A minimum B.Sc. in Biological or related sciences. Advanced degree preferred
A minimum of 5 years of Regulatory Affairs pharmaceutical or related experience is required
Strong working knowledge of the drug development process is required
Strong knowledge of Canadian drug laws, regulations, guidelines and policies, and the Health Authority organizational structure and processes for the review and approval of drug submissions is required
Understanding of the application of laws, regulations, guidances and policies to specific projects. Ability to interpret and understand Regulations in the context of the scientific and commercial environment
Strong scientific writing skills are required
Ability to interpret and summarize clinical data
Well-defined problem solving and analytical skills
This position is located in Toronto, Ontario and may require up to 5% travel

144

Regulatory Affairs Manager Resume Examples & Samples

Working closely with global and local colleagues to advise and agree on regulatory strategy, clinical development plans and data requirements
Critically evaluates data and arguments in order to eliminate deficiencies prior to construction and submission of MA applications within agreed timeframes, Where applicable organises and participates in MHRA scientific advice meetings with global teams to support product development programs
Monitors and influences assessment process to expedite and optimise the outcome of their submissions. Drive negotiations with MHRA to ensure best possible product labelling and delivery of their commitments and deadlines. Work closely with local brand teams to ensure launch readiness plans are in place in order to successfully launch products. Proactive management of artwork, RMP commitments and pre-vetting of advertising materials
Working with global and local stakeholders to ensure optimisation of MA submissions and their compliance with regulations and any other local requirements. Communication of any regulatory changes to the business as necessary
Works closely and swiftly with cross functional teams to address critical issues on batch recall, GCP serious breach or other batch release issues
Ensures submissions are made in accordance with accepted regulatory stand-ards within appropriate timeframes
Creation, submission and maintenance of official local drug information, in-cluding Patient Information Leaflets, SmPCs and packaging texts Customer Provides regulatory advice and support for divestment and in-licensing op-portunities
Provides regulatory advice to global and UK business on all aspects of devel-op
Life Science Degree or other relevant education
Several years of relevant experience of a broad range regulatory work in the ethical pharmaceutical industry

145

Regulatory Affairs Manager Resume Examples & Samples

Independently authors, develops, complies, reviews, maintains and submits high-quality excipient and API Common Technical Document (CTD) and Drug Master Files (DMF’s) with regulators (FDA, EMA etc.)
Completes Annual Reports and other required FDA filings to ensure high-quality submissions and expeditious approvals from FDA. Reviews country specific regulatory requirements to support marketing strategy. Applies for FDA “Certificate of Pharmaceutical Product - CPP” – sales/customer support. Support filings in Europe and Asia, e-CTD, IPEC
Monitors regulatory developments in the pharma area, and work with plants to roll out new FDA and IPEC requirements. Assesses changes and their impact to the business based on an advanced understanding of regulatory guidelines and applicable federal laws. Assists in the formulating sound strategies in support of submission goals
Works with plant /manufacturing sites and research teams to support implementation of appropriate pharma API and excipient GMP’s at Novecare sites and during product development
Prepares excipient information packages which support customer regulatory information requirements and responds to customer regulatory requests
May support the group by making application for, maintaining, and renewing US state and Canadian registrations for fertilizer products and new bio-stimulant offerings
Represents regulatory affairs in project team meetings and provides regulatory guidance and perspective to team members in determining appropriate actions necessary to meet scheduling timelines and/or in resolving technical issues
Minimum of a Bachelor’s Degree in chemistry, pharmaceutical, chemical engineering or related technical major. Master’s degree preferred
Minimum of 5 years in the pharmaceutical industry with 3-4 of those years in regulatory affairs. International regulatory experience desired
Demonstrates in-depth knowledge and understanding of FDA guidelines with proven ability to successfully apply these to work product
Dossier building writing experience,
Strong critical and logical thinker with ability to analyze problems and recommend actions
Effective interpersonal skills allowing for cross-functional team membership and communication,
Knowledge of drug substance import/export regulations desired,
Knowledge of e-CTD formats
Experience building effective relationships with the agency,
Demonstrated capability to stand firm on regulatory requirements while maintaining open perspective

146

Regulatory Affairs Manager, Europe Resume Examples & Samples

BSc life sciences or related field
In-depth experience of pharmaceutical/biotechnology industry
Broad experience of Regulatory Affairs and knowledge of regulatory principles
Knowledge of legislation and regulations relating to medicinal products
Ability to understand and communicate scientific/clinical information
Knowledge of drug development
Knowledge of and experience in regional regulatory environment in relevant product area and development stage
Working with policies, procedures and SOP’s

147

Regulatory Affairs Manager Resume Examples & Samples

Represent Stryker in interactions with external organizations including the FDA and other global health authorities, sponsors, and other organizations; serve as a primary Regulatory contact during all premarket activities and work with Stryker organizations to support the regulatory approval and commercialization efforts in global markets
Develop/approve and implement global regulatory strategies that ensure procedures and policies meet applicable regulations
Plan and manage key projects to ensure resources and support are provided as needed and report metrics to upper management
Provide expert review of FDA submissions, design dossiers, technical files, post market submissions, and other regulatory documents. This includes establishing and maintaining necessary written procedures, such as for submission review and approval, and review of the significance of device modifications to regulatory bodies such as the FDA, MHRA, PMDA, etc
Ensure new regulations or changes to existing regulations are communicated throughout the organization through company policies, procedures, and training
Direct liaison activities with regulatory agencies, preparation, and submission of regulatory documents, as well as management of the regulatory archive
Develop and interpret regulatory requirements from global markets, recommend to Regulatory Affairs and Quality Assurance (RAQA) Management specific activities and resources required to support and execute strategies to further the global growth of the business
Identify evolving regulatory trends including international trends that are relevant and ensure that appropriate action is initiated
Serve as an internal resource to address and resolve any questions or issues of a regulatory nature; provide oversight to RA team to ensure that regulatory decisions are sound and in support of the strategic goals
Work with the RA Management Team to ensure that systems and process are integrated with Stryker Corporate RAQA
Interface with key staff members in strategic planning, product development, operations, and customer service departments to meet scheduled submission dates
Participate in Notified Body and Health Authority inspections
Evaluate data generation carefully in line with scientific principles and company policies. Review and edit materials to meet regulatory requirements and company policy
Participate in joint ventures with other companies to develop and address all necessary considerations involved with reprocessing single-use medical devices
Oversee and/or approve the development of product labels and labeling, and ensure that processes and procedures for product labels and labeling are adequate to meet regulatory requirements
Provide team with ongoing developmental opportunities, supporting team building activities, and promoting a healthy work/life balance
Ensure that direct reports are achieving the business objectives and their professional development objectives
Participate in activities of the Association of Medical Device Reprocessors (AMDR) in reviewing and responding to FDA proposals for regulation of medical device reprocessing
Responsible for the review of collateral material process and works with legal and marketing to ensure collateral material that meets internal and external requirements
Respond to Customer/Sales representative questions and issues
Manage prioritization of team workload and address resource issues as they arise

148

Regulatory Affairs Manager Regional Regulatory Lead Resume Examples & Samples

Planning and managing regulatory submissions (e.g. clinical trial and marketing applications/variations) for
Products in compliance with global filing plans and local regulatory requirements
Ensuring that Amgen acquires and maintains all the licenses in order to support clinical trials for investigational and marketed products in the US

149

Regulatory Affairs Manager Resume Examples & Samples

Lead and maintain global product registration strategy and planning
Provide regulatory support, and leadership to project teams for regulatory issues and questions and ensure that regulatory requirements are addressed prior to submission for market clearance
Work closely with Marketing, Manufacturing, Quality Assurance, R&D, Medical Affairs and New Product Development teams to provide strategic regulatory guidance and review
Prepare core dossier/STED for U.S. and international submissions for products with significant changes
Support Baxter affiliates and distributors to prepare and maintain product submissions and licenses
Understand global regulatory requirements and establish and maintain good working relationships with regulatory agency personnel/Baxter in-country colleagues
Support market-released products by reviewing Engineering Change Orders, labeling, etc. to ensure compliance with regulatory requirements
Evaluate proposed product changes for regulatory impact and preparing necessary documentation
Provide value-added improvements to departmental standard procedures (SP) by authoring original or editing existing standard procedures
May supervise and train junior level regulatory affairs department employees
Demonstrate ability to manage multiple projects and priorities simultaneously
Experience with medical devices with specific experience in: Class I, II, and III medical devices (and/or pharmaceuticals), 510(k) applications and US device regulations and Global medical device regulations and submissions (EU, Canada, Australia, Asian countries, Latin American countries, and Middle Eastern countries)
Bachelors degree or country equivalent in related scientific discipline
Greater than 7 years of regulatory experience
Minimum of two to three years medical device industry experience
Regulatory Affairs Certification (RAC) (preferred)

150

Regulatory Affairs Manager Resume Examples & Samples

Prepare, assemble and submit regulatory submissions, 510(k) submissions and international regulatory submissions in various countries
Prepares regulatory strategies for medical devices products to determine regulatory pathways to market including FDA "Letter to File" rationales for devices. Provide input for regulatory requirements in interdepartmental meetings on product development to ensure timely submission and approval. Determine regulatory filing strategies and submission types. Participate in medical device product development teams and develop overall regulatory strategy that delivers on project costs, timeline and FDA approval. Ensure that project work proceeds according to agreed deadlines and maintain status records
Responsible for performing all duties in compliance with FDA's Quality Systems Regulations, GMP's, ISO13485; and other international regulatory requirements. The manager will also compile and/or review all regulatory agency submission materials to ensure timeliness, accuracy, completeness, and compliance with regulatory standards
Bachelor’s Degree in a scientific discipline or a related field required
Experience filing submissions for medical devices in the US and International markets, i.e. 510(k)s, Technical Files, Summary Technical Documents (STED)
Experience managing functional groups in the development of relevant data to complete a regulatory submission
Experience with submissions for software driven medical devices is preferred
Experience in the areas of drugs, biologics and combination products is preferred
Demonstrated communication and presentation skills
Demonstrated attention to detail and organizational skills
Regulatory Affairs Certification (US or International) is preferred

151

Quality Assurance & Regulatory Affairs Manager for Central Europe Resume Examples & Samples

Bachelor’s or Master Degree in Science
A minimum of eight 8 years, with direct responsibility for Quality Management Systems and related compliance to current Quality Systems Regulation and other relevant standards (e. g. ISO 9001)
Knowledge of QMS requirements applying to in vitro diagnostic products
Quality Engineering and /or Six Sigma Black Belt certification preferred

152

Chemistry Regulatory Affairs Manager Resume Examples & Samples

Lead and support the delivery of global regulatory submission strategies for Monsanto’s Biologicals platform in collaboration with colleagues in the Global Regulatory organization
Provide leadership and build effective relationships with key stakeholders, ensure effective communication, information flow, and effective issue resolution and facilitate collaborations across multiple teams
Provide input and guidance in regulatory studies to ensure that appropriate national and international data requirements are met
Lead preparation of regulatory submissions, monitor and coordinate responses to questions from regulatory authorities, and develop other related documents and processes (e.g., dossier templates, position statements, etc.) to obtain regulatory approvals to support product launches in key markets
Minimum of a Bachelor’s Degree in life sciences or a related field
Minimum of three or more years of relevant experience in the agricultural, chemistry, pharmaceutical, or related scientific-based industry
Prior experience guiding projects from inception to completion to meet changing business needs
Strong analytical skills and the ability to identify solutions to complex problems
Ability to successfully interact with a wide diversity of people and establish effective relationships and networks
Demonstrated leadership skills through people and/or project management
Ability to lead by influence across multiple stakeholders
PhD or Master’s Degree in life sciences or a related field
Understanding of regulatory processes for biotechnology and/or chemistry products
Track record of successful interactions with regulatory governing bodies/agencies
Experience working on cross-functional or matrix teams
Experience making strategic decisions in ambiguous scenarios
Prior experience working for a global organization

153

Regulatory Affairs Manager Resume Examples & Samples

Ensures regulatory requirements set forth in company NDAs and ANDAs are properly maintained, aware of upcoming with regulatory requirements and FDA expectations related to regulatory submissions
Compilation and submission of regulatory supplements to USFDA in both paper and electronic (eCTD) formats
Coordinate with Manufacturing, QA, contract service providers (e.g. manufacturers, laboratories, packagers, etc..) to compile documents for regulatory submissions to support the CMC sections of the registrations dossier
Prepare, submit, track, index, and archive paper and electronic submissions
Aware of regulatory requirements related to Tech Transfer
Ensure labeling content is developed according to regulatory requirements
Assisting in the coordination of label review and approval
Review and assess the regulatory impact of changes related to company products
Develop and/or update CMC Regulatory SOPs when necessary
Maintain Regulatory documentation files, databases, and logs

154

Regulatory Affairs Manager Resume Examples & Samples

Manage the Communications business Regulatory team. Hires, trains, supervises, motivates, and develops staff; manages schedules and workflow. Responsibility includes Communications business site located in Germany
Accountable for regulatory strategy, deliverables, and results to support new product development both domestically and internationally
Accountable for post market regulatory compliance including complaint handling, adverse event reporting, recall decisions, reporting, and execution
Lead external audits including direct interaction with FDA, ISO, and other external auditors. Serve as lead during corporate internal audits
Provide regulatory guidance to and interact with cross functional business partners including R&D, Marketing, Quality, Operations, Legal and Compliance
Stay abreast of regulatory standards/guidances and communicate relevant information within the business
Participate in due diligence and acquisition integration activities; provide RA oversight and leadership
Support Quality System activities including NC/CAPA, Internal Audit, and change control
Maintain facility registrations

155

Regulatory Affairs Manager Resume Examples & Samples

Leads the development and execution of an effective regulatory affairs strategy to ensure best possible relations with various regulatory agencies
Plans and supervises regulatory activities for assigned programs and establishes priorities for submissions based on departmental goals and objectives and establishes schedules and assigns work to staff
Ensures there is a process in place for regulatory database update and accuracy
Oversees the regulatory activities with OC & regional team to ensure timelines for product registration and key projects are met
Ensures timely and accurate communication with customers, anticipates franchise needs and incorporates them in the RA submission plan
Acts as the link between functional areas and franchises with the rest of the RA team in the country-region
1) Education level required: Bachelor’s Degree in Engineering, Pharmacy or other life science
2) Years of Experience: Must have 5 years experience working in a Regulatory Environment preparing submissions for complex devices or other product categories and a successful track record
3) Language: Fluent in English
4) IT Tools: Microsoft office (Advanced), Trackwise & SAP.5618170322

156

Regulatory Affairs Manager Resume Examples & Samples

Tertiary qualification, preferably with Medical qualifications
Knowledge of China Regulatory Environment and Processes, Testing Centers and SFDA
Proven record of regulatory submission and product registration completion under China's regulatory environment
Implementation of Quality System
Be sensitive & appreciate the differences between East & West business and cultural practices

157

Biotechnology Regulatory Affairs Manager Resume Examples & Samples

Lead a cross-functional Product Core Team in Regulatory and work closely with colleagues across Research & Development, as new products are advanced to the Regulatory organization, to develop and execute a robust assessment strategy that fully-characterizes and evaluates product safety, meets global regulatory requirements and ultimately enables commercialization for sale and distribution
Work in close coordination with many other functional areas within a matrix organization including Global Regulatory Affairs, Regulatory Sciences, Regulatory Policy and Scientific Affairs, Biotech, Breeding, Industry Affairs, Corporate Affairs, Commercial, Legal, Supply Chain and Stewardship
Work in a cross-functional capacity to build and implement approval strategies to obtain both U.S. and international regulatory approvals, use their scientific/technical background to provide input on regulatory technical strategies and reports, and prepare documents to support product registrations in the U.S. and other production and key export countries
Interact with regulatory agencies and licensee companies as needed
Minimum of a Bachelor’s degree in Molecular Biology, Crop Science, Genetics, Plant Breeding, Plant Pathology, Biochemistry, Protein Chemistry, Toxicology or related scientific discipline
Minimum of three or more years of relevant experience in the agricultural, biotechnology, Regulatory/Government/Industry Affairs, pharmaceutical or related scientific based industry
Strong written and oral communication and organization skills, with a proven ability to convey complex ideas in a clear, precise, and actionable manner
Ability to drive and manage projects cross-functionally and develop/execute strategic plans
PhD or Master’s Degree in Molecular Biology, Crop Science, Genetics, Plant Breeding, Plant Pathology, Biochemistry, Protein Chemistry, Toxicology or related scientific discipline
Five or more years of relevant experience in the agricultural, biotechnology, Regulatory/Government/Industry Affairs, pharmaceutical or related scientific based industry
Prior experience building strategic plans and leading projects cross functionally and globally
Experience working for a global organization

158

Regulatory Affairs Manager Resume Examples & Samples

Substantial experience of working within RA, research governance, quality assurance or PV & S
Able to demonstrate professional knowledge within RA and PV & S
Proven experience in developing new systems and processes
Experience of leading, line managing or supervising a team
Evidence of ability to undertake and deliver specific projects and supervise short term project teams
Experience of working in industry or a Postgraduate/Professional qualification
Experience of working in a trials environment

159

Regulatory Affairs Manager Resume Examples & Samples

A minimum of 3 years of Regulatory Affairs pharmaceutical OR related experience is required
Experience in the oncology therapeutic area is highly desirable
Understanding of the application of laws, regulations, guidances and policies to specific projects
Ability to interpret and understand Regulations in the context of the scientific and commercial environment
Excellent customer and market place focus
The position location is Toronto, Ontario and may require up to 5% travel

160

Regulatory Affairs Manager Resume Examples & Samples

Manages systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions
Responds to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to affiliates
Assists with the research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products. Interprets results of research
Assigns Regulatory Affairs (RA) professionals to serve on development project teams as core team members; communicates regulatory strategy for new products
Keeps all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of products
Supports, supervises, and participates (as necessary) in the development of package inserts, evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status
Writes, manages, and approves the development of package inserts
Reviews, evaluates, and approves promotion and advertising material for compliance with applicable regulations
Interprets and applies FDA regulations to business practices and provides regulatory input, advise, and guidance to the organization
Establishes Zimmer Biomet RA policies and procedures and ensures compliance with them
Provides training and guidance to entry-level associates, interns, specialists, and project managers
Communicates with Regulatory/Governmental agencies
Responsibility for oversight and prioritization of departmental tasks and projects
Directs and oversees the work of regulatory professionals, including training, mentoring and ensuring professional development
Miscellaneous responsibilities as assigned
Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory agencies, superiors, peers, and direct reports
Strong interpersonal, organizational, problem-solving and analytical skills; strong attention to detail
Ability to manage competing priorities; ability to manage projects of various sizes, constitutions, and management of personnel; versatility, flexibility, and willingness to work with changing priorities
Advanced knowledge of overall business environment, the orthopaedic industry and the marketplace; strong product knowledge
Mastery of relevant regulations, and ability to stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as applicable
Ability to function well as a member of the team and team leader, as well as build relationships between RA and other areas of the organization
Ability to identify and asses business risks to develop Regulatory strategy
Mastery anatomic knowledge
Ability to handle increasing levels of responsibility
Ability to build and lead a strong RA team; ability to lead and influence others
Ability to negotiate with regulatory agencies, management, and other groups as necessary
Advanced knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU as applicable
Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
Advanced degree strong preferred
6-8 years of experience in Regulatory Affairs, including preparation of submissions to the FDA/EU
A minimum of 3 years of experience in medical device, drugs, biologics, and/or combination products, preferred
Regulatory Affairs Certification (US or EU) preferred
A combination of education, experience, leadership, strategy and RA influence may be considered

161

States Regulatory Affairs Manager Resume Examples & Samples

Responsible for creating processes around a variety of registration types, ensuring tracking of the registrations, communicating approvals to stakeholders, and increasing efficiencies of the state submission process
Provide direction to the business with respect to state registration strategies for new and existing products ensuring that Monsanto’s products comply with the state regulations
Collaborate with the business teams, Government Affairs & Industry Affairs on the identification, implementation, and management of regulatory acceptance and stewardship issues
Maintain knowledge of changing regulatory policies and procedures to ensure compliance; assist in disseminating state regulations and guidelines with appropriate interpretation
Plan and execute state submissions that ensure timely approval of product registration in line with Marketing/Sales launch goals
Develop and write clear arguments and explanations for new product registration
Prepare applications to maintain/support existing state registrations for annual renewals and coordinate and resolve stop sale situations with marketing, legal and customer service
Facilitate chemical product labeling generation
Establish and build positive relationships and points of contact with state agencies and industry leaders to represent organizational interests and perspectives
Support Commercial Business and Supply Chain in the management of changes to existing commercial products
Work with the US States Regulatory Affairs team, Biotech/Chemistry/Seed Regulatory Affairs teams, Regulatory IT team, and TPS to develop state submission policies across variety of product types
Collaborate to ensure timely filings of product registrations, renewals, special assessments and reporting requirements
Minimum of a Bachelor’s Degree in the chemical, biological, agricultural, biotechnological, or related sciences
Ability to identify, respond and independently work through varying requirements and /or demands relating to internal/external customers, state regulators and state legislative changes that impact product portfolio
Ability to collaborate across multiple functions with proven ability to build and maintain strong networks and relationships, leverage external relationships to execute business strategies, and collaborate with people from other organizations to accomplish goals
Strong understanding of regulatory environment through direct experience or involvement with Regulatory matters
Demonstrated ability to communicate effectively (both written and oral) including strong interpersonal and analytical communications
Strong interpersonal and facilitation skills to deal effectively and tactfully with people at all levels of management, with the ability to secure action from staff and management in a matrix organization
Strong results orientation with the ability to think strategically while paying close attention to details
Strong track record of consistently meeting milestones and commitments
Ability to develop and implement an effective and efficient regulatory submission strategy
PhD or Master’s Degree in a scientific field or closely related discipline
Experience in chemistry and/or biotech products
Two or more years of experience dealing with regulated material, regulatory agencies and/or compliance
Prior experience working in a global and/or matrix environment
Demonstrated ability to identify, think through and plan long term processes that integrate future growth/changes
Knowledge and experience related to establishing and leveraging liaison relationships with regulatory agencies
Prior experience analyzing complex, multidisciplinary challenges involving chemistry and/or biotech regulatory and compliance issues
Prior experience initiating and implementing technical improvements to drive efficiency and productivity
Knowledge of required FIFRA label elements (signal words, precautionary language, personal protective equipment, and mandatory label language)

162

Regulatory Affairs Manager Resume Examples & Samples

Coordinates and prepares (i.e., plans, writes, and reviews) timely submissions (EU and US), including interfacing with other departments to obtain the necessary components and reports in accordance with regulatory agencies’ guidelines
Reviews submission-related documents from clinical, pre-clinical, research, development and manufacturing to ensure consistency with regulatory submissions and compliance with applicable regulations
Keeps abreast of current US and international regulatory practices, procedures and changes, as appropriate by project. Assesses impact of the changing regulatory environment to the project, and advises regulatory colleagues and project team members, as appropriate, regarding potential course(s) of action
Participates in and/or represents Regulatory Affairs on project teams
Maintains regulatory filings or records, including archive of EU or US submissions and FDA correspondences files
Actively participates in the development of regulatory strategies in conjunction with senior RA personnel
Regularly interacts with management regarding regulatory matters
May supervise or provide guidance to lower level staff
Perform other related duties as required
Bachelor’s degree or equivalent with 5 years’ experience in Regulatory Affairs in a biotechnology, pharmaceutical, or medical device company
Must be able to work in a fast paced environment with demonstrated ability to effectively manage multiple competing tasks and demands
Ability to drive projects to completion within deadlines
Ability to negotiate and influence others
Ability to manage projects
Strong communication skills (interpersonal, written, verbal, listening)
Demonstrated time management (timelines, schedules, task prioritization)
Detail and accuracy oriented

163

Regulatory Affairs Manager Resume Examples & Samples

Participate in internal meetings and present the Regulatory Affairs perspective to the product team while working with teams to manage priorities and meet submission filing dates
Establish global regulatory strategy with the Regulatory Project Leaders
Lead internal efforts pertaining to development, submission, and maintenance of worldwide regulatory filings and product labels
Assist in coordinating regulatory agency meetings and preparing meeting materials
Perform US and international regulatory research tasks and assist in the development of regulatory strategies
Develop and maintain current regulatory knowledge
Participate in Regulatory Affairs initiatives aimed at improving internal regulatory standards and systems
Ensures company strategy is written clearly and represented in Regulatory documents and submissions
Prepare and deliver polished presentations in team settings, with management and occasionally senior leadership
Serve as liaison and influence project team direction
Align cross-functional team members for maximum effectiveness
Master’s Degree, or equivalent, preferred
Minimum of 8-10 years Regulatory Affairs experience required
Prior experience with draft/approved product labeling, labeling processes and Company Core Data Sheet preferred
Applies appropriate industry policies and practices in preparing materials
Understands basic company systems, budgets, financial goals, metrics and competitive submissions
Coordinates and negotiates with agency authorities to ensure successful submission approvals
Provides input on global strategy in project teams
Monitors impact of changing regulations on submission strategies and advises internal stakeholders
Clear understanding of content and organization of regulatory submissions in eCTD format, as well as ICH and FDA Guidances
Experience with global regulatory submissions (INDs, CTAs, MAAs)
Experience with post-marketing/ promotional review and product labeling a plus
Attention to detail, organizational skills, and a demonstrated ability to prioritize multiple projects. Excellent written and verbal communication skills
Motivated, self-starter, able to work independently with minimal supervision

164

Regulatory Affairs Manager Resume Examples & Samples

Bachelor's degree or equivalent in Science or related discipline
Knowledge of regulatory requirements in Singapore
Understanding of operational process implication caused by product registration status changes is a plus

165

Assistant Regulatory Affairs Manager Resume Examples & Samples

Complete e-learning/training on RA and QA global and local SOPs
Ensure team compliance on quality and regulatory requirement internally and externally e.g. OPAL reporting, GMS
Provide/encourage training and people development to increase productivity and performance
Performance appraisal & objective setting
Monitor on compliance

166

Regulatory Affairs Manager, CMC Resume Examples & Samples

Develop and implement CMC regulatory strategies for investigational and marketed products
Provide regulatory expertise and leadership as member of CMC product development teams
Work closely with site Regulatory to support marketed products activities and maintenance of submissions
Proactively communicate and engage with RA project leaders, other RA functions, management, corporate partners and external experts
Act as point of contact with FDA for CMC regulatory matters for investigational products
Lead cross-functional resources to compose high quality, global CMC investigational and marketing dossiers
Ensure regulatory documents are comprehensive, complete and accurate
Maintains dialogue with regulatory agencies/personnel in support of Alkermes applications, including development of responses to Regulatory Agency CMC questions or requests for information
Monitor the development of new requirements, guidelines and trends through information gathering and participation in industry groups
Contribute to the development and implementation of RA best practices, quality systems and policies
Bachelor of Science (or equivalent degree) in a scientific discipline
Minimum of ten years CMC experience, including six years in Regulatory Affairs
Experience/background and training in all aspects of Regulatory Affairs including

167

Regulatory Affairs Manager Resume Examples & Samples

Educational background in Biology, Chemistry or Biochemistry
Regulated industry, GMP experience
Understanding of drug development or drug commercial process
Experience in the development, review and maintenance of global regulatory dossiers
Ability to review regulatory documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
Ability to communicate with corporate business functions and internal business partners
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
Successfully work within a team/partnership environment
Leadership and strong communication skills
Fundamental project management skills
Experienced in process improvement methodologies
Good analytical problem solving skills
Strong communication skills - oral and written (English and Spanish)

168

Senior Regulatory Affairs Manager Resume Examples & Samples

Responsible for Regulatory and Compliance support for projects within the Virology/Blood Screening Lifecycle teams
Responsible for the coordination and preparation of document packages for regulatory submissions
Recommends changes to labeling, manufacturing, marketing, and clinical and development protocols
Oversees the collection of documents, reports, records and data from Development, Clinical Affairs, Quality and Operations Department for inclusion in regulatory documents
Manages submissions for FDA product approval including 510k's, PMA's, IDE’s, IND's, BLA's as assigned
Reviews product labeling/advertising to ensure compliance with federal regulations
Prepares international registration dossiers (primarily those having to do with Quality, Operation or Compliance for use in international registration by Roche Diagnostics Affiliates
Works independently on diverse problems requiring significant analysis and evaluation of intangible variables; may refer to established precedents and policies
Represents Regulatory Affairs on project teams and is responsible for monitoring the activities associated with the project plan
Manages regulatory responsibilities associated with the development, support, and manufacturing of the Company’s medical device products (including compliance)
Reviews product labeling to ensure conformance with Regulatory requirements and/or approved product claims
Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects
Oversees the “agent in charge” for audits and serves as primary liaison with plant compliance officers to direct strategy and documentation requests during an audit

169

Regulatory Affairs Manager Resume Examples & Samples

Support submission of applications to EU competent authorities
Identification of the central Institutional Review Board (IRB), Ethics Committee (EC), and essential regulatory documents (CTA’s) required for multiple global projects
Development of Regulatory Document Management Plan, review of initial regulatory documents for site activation, and maintenance of internal CTMS for tracking study site status site initiation through study maintenance
Manage project scope, timelines and budgets while serving as key source of communication to senior management ensuring their awareness of project status
Work directly with Global Head of Regulatory Affairs, Director of Clinical Monitoring, EVP, Clinical Operations, Project Managers and Clinical Trial Managers in execution of multiple regulatory affairs projects
BSc in a health-related field with approximately 5 years of regulatory experience including 3 years in a management role
Pharmaceutical clinical research experience and electronic data management experience are required
Excellent demonstrated knowledge of issues affecting regulatory affairs for clinical trials is required. Excellent written and verbal communication skills are required
Documented continuing education in regulatory affairs or Regulatory Affairs Certification preferred

170

Senior Regulatory Affairs Manager Resume Examples & Samples

Regulatory Strategy
BS required with 5+ years of experience, MS with 3+ years of experience or Ph.D. with 2+ years of experience
Demonstrated ability to communicate regulatory requirements
Fluent in English, both written and oral
High-level verbal and written communication skills
Communicates cross-functionally and cross-company as well and presents and defends CMC management-approved regulatory strategy and opinion to corporate project teams
Demonstrates model behavior that understands what the priorities are and encourages others to drive for results

171

Regulatory Affairs Manager Resume Examples & Samples

Cover lifecycle maintenance for Mkted product and labeling
Involve into RA policy change via JnJ and industry platform
Develop people and build team with performance excellence
Own work related knowledge on CMC/ clinical/regulations
Lead or involve into crises related to RA
A master degree major in chemistry, pharmaceutics, biology or a related life-science discipline
Have good communication with HA
Fluent English in verbal and written; good computer skill, good presentation skill.1700156161W

172

Regulatory Affairs Manager Resume Examples & Samples

Conduct regulatory assessments of CMC change controls
Work with the GRT to provide CMC input to global regulatory strategy and submission plans
Provide input to pharmaceutical development, manufacturing site(s), and commercial packaging selection as decisions can have an impact on the filing strategy
Advanced degree required in a scientific or engineering discipline
5-10 years’ experience in a significant leadership position within the pharmaceutical industry
Experience in a Quality leadership role would be desirable but not essential
Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals
Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position
Proven success in managing in a global organization

173

Senior Regulatory Affairs Manager Resume Examples & Samples

Oversee the development and implementation of global regulatory strategy in conjunction with global RA staff
Manage FDA and notified body relationships directly and through the Coronary RA team
Ensure the timely and accurate filing of all regulatory documentation
Ensure compliance with Quality System Regulations and associated requirements
Manage systems and programs in support of corporate goals and objectives
Represent CRDN RA as a member of site, business, or corporate process improvement initiatives
Establish and maintain a professional relationship built on mutual respect with key physicians, consultants, vendors, co-workers, and regulatory agencies
Recruit, hire, train, manage, and develop regulatory affairs staff members
Actively promote team building and maintain positive morale within the department
Stay current with respect to competitive technologies and associated regulatory strategies
Regularly make presentations to senior staff members
Procure and oversee outside vendors and consultants as required

174

Regulatory Affairs Manager Resume Examples & Samples

Define regulatory strategies and timelines for regulatory submissions for the total product lifecycle for medical and non-medical software products
Collaborate with Product Development teams by providing regulatory strategy, timelines and deliverables; work closely with product development engineering, clinical, marketing and regulatory functions to assure appropriate requirements are defined for the specific device claims and target patient population
Manage preparation (developing submission content, management of document legalization/apostille, and creation of any other documents required for submissions) and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution clearances in accordance with regulatory strategic plan
Ensure timely, professional and proactive communications with internal customers to ensure transparency of the regulatory strategic plans, updates/changes and impact to projected submission approval timeframes, as well as external customers to ensure applications are submitted to local health authorities consistent with regulatory strategic plan
Communicate and interact directly with regulatory bodies and local health agencies such as FDA to ensure adequate and appropriate information is provided as well as driving submissions to approval as effectively as possible
Control and maintain regulatory records, including, but not limited to: submission documentation, tracking of part number approval per country, establishment registrations, import for export, etc
Identify, develop, implement and document process improvements to drive efficiency within the organization
Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including EU country specific regulations, LATAM country specific regulations, Health Canada regulations, FDA regulations and policies applying to medical devices including, 510(k)s, 21 CFR 820, 21 CFR 801, global registration, technical writing, etc

175

Regulatory Affairs Manager Resume Examples & Samples

Coordinates and prepares (i.e., plans, writes, and reviews) timely submissions, including interfacing with other departments to obtain the necessary components and reports in accordance with regulatory agencies’ guidelines
Maintains regulatory filings or records, including archive of submissions and FDA correspondences files
Assists with publishing or compilation of US, Canadian, EU and/or Latin America papers and/or eCTD submissions

176

Regulatory Affairs Manager Resume Examples & Samples

Manages and leads individual contributors
Monitoring, notification, and guidance to business lines on industry news and proposed or regulatory changes, including quarterly reporting to senior management
Oversight of regulatory inquiries, including monitoring, notification, tracking, and reporting
Serves as the primary contact for regulatory agencies, including corresponding and interacting with regulators on relevant issues
Serves as the primary contact for internal (enterprise) programs, including corresponding and interacting with senior US Bancorp Compliance and Risk Management employees
Representation of the firm at various regulatory agency meetings and events
Ensures timely and accurate reporting of required regulatory filings
Liaison with counsel and other stakeholders on regulatory matters to limit legal exposure such as enforcement sweeps
Gathers applicable documents and draft responses to routine regulatory inquiries and examinations. Tracks and pulls requested documents and coordinates efforts with departments/branch offices to gather information. Researches and drafts responses where necessary. Reviews information for trouble spotting prior to submission to regulatory agency
Advises on the development of new or revised policies and procedures for the firm by attending applicable meetings, giving input, performing research, producing written drafts, making changes and assisting with implementation and training, where applicable
Performs reviews as necessary to ensure compliance with regulations
Corresponds and interacts with other members of Compliance, home office and branch associates, including Financial Advisors, Supervisory Principals, and support staff on relevant issues
Corresponds and interacts with various business units throughout the Firm and its affiliates as needed to assist in development and implementation of policy and procedure changes resulting from regulatory reviews or examinations findings
Performs other duties as assigned by Chief Compliance Officer
Advanced knowledge of concepts, practices and procedures of securities industry compliance
Advanced knowledge of rules and regulations of the Securities Exchange Commission (SEC); Financial Industry Regulatory Authority (FINRA); and state securities regulatory agencies
Advanced knowledge of financial markets and products
Advanced knowledge of investment concepts, practices and procedures used in the securities industry
Experience investigating compliances issues and irregularities
Ability to make rule-based and analytical decisions
Identifying and applying appropriate compliance monitoring procedures and tests
Written and verbal communications skills sufficient to professionally address a wide and varied audience both internally and externally
Ability to prepare oral and/or written reports
Ability to operate standard office equipment and using required software applications
Experience working under pressure on multiple tasks concurrently, manage those delegated; and meet deadlines in a fast-paced work environment with frequent interruptions and changing priorities
Attention to detail while maintaining a big picture orientation
Ability to use appropriate interpersonal styles and communicate effectively and professionally, both orally and in writing, with all organizational levels to accomplish objectives
Ability to establish and communicate clear directions and priorities
Maintain current in laws, rules and regulations related to compliance in assigned functional area (s)
Ability to plan, assign, monitor, review, evaluate and lead the work of others; coach and mentor others
Experience managing all levels of associates, including technical, professional, clerical, administrative and supervisory associates
Ability to work independently as well as collaboratively within a team environment to resolve problem
Series 7, 9, 10, 24, 53, 63, 65/66 Licenses or the ability to obtain within one year of employment

177

Regulatory Affairs Manager Resume Examples & Samples

Drive and implement the glyphosate EU renewal process
Support and implement GTF activities on behalf of Monsanto
Coordinate the Article 43 renewal process for glyphosate based products
Draft and review final regulatory applications (glyphosate dossiers)
Manage regulatory glyphosate dossier submissions from Time of application to authorisation
Liase with cross-regional RAMs supporting glyphosate registrations
Provide regulatory support throughout life cycle of glyphosate products
Master degree or higher in relevant scientific discipline, preferably in agronomy,applied chemistry, plant sciences or environmental sciences
In depth knowledge of relevant EU regulations directives and dossier prescriptions

178

Regulatory Affairs Manager, Device Team Resume Examples & Samples

9) May review promotional material or SOP's for compliance with local and global regulations
8) Bachelor’s degree or country equivalent in engineering (Engineering degree in Electrical, Mechanical, Software, or Biomedical engineering) or related scientific discipline; Higher degree/PhD will be an advantage
9) Minimum of 5 years US regulatory experience in medical devices or related field, including managing people or projects and direct authoring of 510(k)s - direct exposure to FDA 510k submissions on electromechnical devices
10) FDA 510k experience on Class II Electromechanical Devices where candidate played lead role in execution of submission or has provided support to one in a significant way under direction from someone. Q-sub submissions/execution ideal

179

Regulatory Affairs Manager Resume Examples & Samples

Provide the regulatory and product safety support for the product portfolio in China
Ensure on-going regulatory and product safety compliance of Reckitt Benckiser existing product portfolio
Lead and co-ordinate the resolution of regulatory, medical and product safety issues affecting products in China
Provide regulatory affairs support and consultancy to internal and external customers in a business oriented way
Work closely with external partners, contractors and licensees to ensure that regulatory, safety and medical affairs issues are properly managed and resolved
Responsible for the regulatory activities for all healthcare products within China
Ensure the registration and regulatory compliance of Reckitt Benckiser’s marketed products with relevant national regulatory requirements to bring competitive advantage to our healthcare brands
Ensuring the compilation of national dossiers for submissions to authorities
Ensuring the amendment of registration dossiers as necessary for country-specific regulatory requirements and overseeing the submission of registration/variation applications and negotiating with governmental authorities to obtain rapid approvals
Developing national texts (e.g., PIL, SPC, packaging) including coordination of translations
Developing and maintaining a database of local regulatory requirements
Providing regulatory and product compliance expertise in the healthcare area of advertising, label claims and printed materials for existing and new products
Support the management of Pharmacovigilance activities for all healthcare products are carried out within China
Manage assigned specialist products
Keep abreast of the local and global regulatory environment and execute assigned regulatory activities
Work with Regional Regulatory Affairs Director to execute activities in China
Regular updates on latest regulatory affairs development in China and provide insights on compliance matters and healthcare related regulatory affairs
Interfacing with local government agencies and industry associations to assess the impact and implementation of required company compliance with all healthcare related regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of our products
Graduate level in life science, preferably in pharmacy
4-6 experience in regulatory affairs, preferably in MNC pharmaceutical or FMCG Company

180

Regulatory Affairs Manager Resume Examples & Samples

Excellent problem-solving skills, sound judgment and strong interpersonal, presentation and communication skills
Strong Leadership skills, as required
Strategic-thinker, goal- and team-orientated, able to handle difficult issues in a professional, assertive and proactive manner and history of developing cross-functional relationships with all levels of an organization
Practical, business-oriented approach to problem-solving, tempered by an appreciation of legal complexity and risk
Participates in process improvements across teams and organizations
Maintains knowledge of industry, and regulatory developments that affect the Company and informs management as appropriate
Works closely with all members of the team in managing general regulatory projects
Develops understanding of Company’s business operations and ongoing related Regulatory issues in order to proactively identify and mitigate these risks
Support the development, monitoring, and control of department policies and procedures
Develop strong business relationships with internal customers and with other departments
5-7 years’ experience in diagnostics, pharmaceuticals, medical devices or vaccines. Animal Health or veterinary medicine preferred

181

Regulatory Affairs Manager, Malaysia Resume Examples & Samples

Compile the relevant data packages to ensure registration and legal compliance
Support to SEA Sales requests regarding near to market projects, regulatory statements, MSDS, labels etc
Create and collaborate with a wide network of NZ Distributors in SEA to ensure the above
Law monitoring, interpretation and communication of law and regulations in SEA relevant to NZ enzymes business
Interaction with relevant authorities and trade associations to navigate the above

182

Regulatory Affairs Manager Resume Examples & Samples

Understanding of product/ process quality standards
Written and Verbal communication; local language knowledge, fluent in English
Technical system skills
Knowledge of regulations
Basic managerial skills
Strong interpersonal communication

183

Senior Regulatory Affairs Manager Resume Examples & Samples

Bachelor/Master of Science degree in a software, technical, or biomedical discipline
Minimum of 5 years of experience in medical device regulated environment
Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwide
Excellent working knowledge of medical device regulations, FDA law, MDD, other global laws and regulations
Experience in supporting international registrations (FDA) and clinical investigations (preference)
Knowledge of the CFDA requirements is preferred
Enthusiastic, self-motivated regulatory professional
Good communicator and team player who is able to work in a flexible and goal-oriented environment
Analytical / systematic / logical thinker
Helicopter view ensuring that the pieces of the puzzle fit content and process wise
Structured way of working; Problem solving and time management skills

184

Quality Assurance & Regulatory Affairs Manager Resume Examples & Samples

Local Manager - Technical and Vigilance Responsible for medical devices (MD) to the Competent Health Authorities (CA), leading quality, regulatory and surveillance activities, overseeing the SOP implementation to comply with global company policies and legislation in force
Consultant in National/European Legislation, keeping external/internal relations (CA, local external organizations, Professional Associations, and other departments), working closely to set the best Quality & Regulatory (Q&R) strategies
Contribute to the Q&R input into the commercial team for the implementation of special projects
Support to the EMEA Q&RA Director in the management of strategies under his/her responsibility and cross-functional projects
Management and coordination of Q&RA Technician’s activities
Implement and manage key Q&R projects either on an individual basis or as part of the EMEA Q&R Management Team, based on both short and long term business objectives and strategic imperatives, including cross-functional project teams
Ensure the effectiveness and efficiency of the processes in the Q&R Department
Monitor Q&R activities in accordance with reporting lines and assist the EMEA Q&R Director and the International teams with the management of projects as necessary to ensure compliance with authority and corporate requirements in the shortest timeframe
Establish, keep and make available to the Competent Authorities (CA) all documents
Supervise the legitimacy of the origin of the healthcare devices that are supplied, ensuring that they meet the requirements stipulated in regulations
New products distribution notifications, market launchings and/or initial use
Maintenance of the marketed products (labeling, DoC, CE mark, TDS), as appropriate
Supervise the messages intended for advertising and promotion of marketed products
Set up and maintain a local surveillance system to evaluate incidents related to the products distributed and have access to all means for notification to CA
Approve/manage the local Quality activities
Sign the standardized working procedures and take responsibility for knowledge and acceptance by the personnel involved ensuring the implementation and the compliance with the company quality policies
Supervise distribution activities, in compliance the standardized working procedures
Ensure the management of complaints, field actions (recalls), NC/CAPA, returns
Warehouse Quality Assurance (Repack, quality holds, waste management)
Bachelor's degree from an accredited college or university in a related field required
Certification or Licensure, preferably related to Health and Life sciences or Chemistry/Pharmacy graduate to honors level or equivalent
Managerial experience required
Must pass pre-employment processes

185

Regulatory Affairs Manager Resume Examples & Samples

1) Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
2) Represent or lead the RA function on assigned cross-functional project teams 3) Monitor applicable regulatory requirements; assure compliance with Baxter and external standards
4) Establish appropriate communication within RA and other functions primarily at project level
5) Perform gap analysis and propose solutions
6) Develop and document sound regulatory decisions and justifications
7) Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
8) May review SOP's for compliance with local and global regulations
1) Sound basis of Regulatory knowledge
2) Scientific Knowledge
4) Software and/or mechanical device knowledge
5) Strong oral and written communication and presentation skills
6) Demonstrated interpersonal skills including strong negotiation skills
7) Ability to independently identify compliance risks and escalate when necessary
8) Ability to lead and coach others
9) Bachelor's degree or country equivalent in related scientific discipline with a minimum of 5 years regulatory experience in RA or related field, including managing people or projects
10) Engineering degree or higher degree/PhD will be an advantage
Develop and execute Regulatory Strategies,
Influences change (internal and external),
Participate on Industry working groups,
Identify and make risk trade-off decisions,
Negotiation skills to ensure regulatory requirements are met, deliveries on complex projects and commitments,
Experience with hardware and software devices

186

Healthcare Accreditation & Regulatory Affairs Manager Resume Examples & Samples

Oversee the coordination of licensing, accreditation affairs, and related surveys/inspections
Maintain the organizational continuous survey readiness program, including auditing/monitoring and maintenance of designated accreditation software applications
Lead, coach, and mentor multidisplinary teams in the assessment and maintenance of regulatory and applicable clinical process accreditation standards for compliance readiness
Support ongoing communication of applicable local/state/federal clinical process/outcome regulations and specified accreditation program standards to employees and medical staff with emphasis on functional importance of compliance
Prepare and present information to a variety of audiences and committees regarding aspects of the organization's state of continuous readiness for applicable regulatory and accreditation program survey
Proficiency with various software packages
Excellent communication (written & verbal) and presentation skills, expert listening, and interpersonal skills
Strong interpersonal skill; ability to work effectively with personnel at all levels within the organization
Discerning assessment and appropriate decision making skills, including skills in priority setting and multi-tasking
Ability to excel in a team environment while operating with individual autonomy

187

Regulatory Affairs Manager Resume Examples & Samples

You have the responsibility for the preparation and submission of pre- and post-approval documentation for veterinary biologicals (vaccines) mainly in Europe - with major focus on quality section of the dossier, incl. detailed and critical summaries
You will participate in international project teams as RA core- or CMC subteam member and provide regulatory assessment according to current legislation and requirements
For new and authorized products you will develop and realize regulatory strategies
Furthermore, you prepare, co-ordinate and respond to the list of questions from authorities/affiliates and assure the consistency of the responses
You will liaise with EU competent authorities/R&D vaccine/external experts and maintain contact between and within OPUs/ licensees to assist with pre-and post-approval regulatory issues

188

Regulatory Affairs Manager Resume Examples & Samples

Actively participate in product registration projects on defined global markets
Compile and submit required documentation to obtain registration licenses
Communicate with internal and external partners and with regulatory authorities in specified countries
Participate in product development as regulatory expert
Participate in the vigilance process
Proactively provide regulatory requirements and communicate clear regulatory strategies for development projects
Review and approve product documentation
Contribute to improved routines and processes for the Global Regulatory Affairs team
University degree in natural or pharmaceutical science, knowledge in Immunology is of advantage
3+ years experience in global IVD product registration is a plus
Experience from US, Asian, East European and/or South American countries is a plus
Practical experience in Quality Management (esp. ISO 13485) is of advantage
Fluent in English and German, both spoken and written
Independent and well-structured approach of tasks
Excellent team working and communication skills
Positive attitude and service-minded

189

Category Regulatory Affairs Manager Resume Examples & Samples

Degree in a pharmaceutical or life sciences (or equivalent experience)
Experience with at least one of medical device, cosmetic or medicinal regulations, ideally within a Consumer Healthcare environment
Proven record of developing regulatory strategies
Aptitude for reviewing Consumer Focused Copy
Experience of working on similar or Consumer Healthcare related products
Awareness of regulatory processes in at least one geography
Demonstrated ability to work autonomously

190

Regulatory Affairs Manager Resume Examples & Samples

Manages systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the FDA regulatory submissions process. May author and publish electronic submissions
Manages the development of dossiers for registration of products in countries outside the US. Oversees the authorship and publication of electronic submissions
Assigns RA professionals to serve on development project teams as core team members; communicates regulatory strategy for new products
Communicates with Regulatory agencies
Directs and oversees the work of regulatory professionals, including training, mentoring and insuring professional development
Interprets and applies FDA regulations to business practices and provides regulatory input, advice and guidance to the organization
Responsible for interacting with governmental agencies
Strong writing and communication skills; ability to communicate effectively at multiple levels, including Regulatory agencies
Knowledge of medical device products and regulations and ability to interpret them
Ability to lead a team, influence others, and handle increasing levels of responsibility
Ability to build relationships with other areas of the organization (i.e. marketing, research)
Understands the overall business environment, the orthopedic industry, and the marketplace
Ability to identify and assess business risks to develop Regulatory strategy
Ability to manage/supervise employees
Bachelor’s Degree in life sciences, technical (engineering) or related field or non-US equivalent
Advanced degree strongly preferred
A minimum of 6 years of experience required in a Regulatory Affairs capacity
Experience in the areas of drugs, biologics, and combination products regulations is strongly preferred
A combination of education and experience may be considered

191

Regulatory Affairs Manager Resume Examples & Samples

Over 10 years experiences in Research & Development of pharmaceutical industry including at least 5 years experiences in regulatory affairs with experiences for conducting PMDA consultations and CTN submission of pharmaceuticals in Japan
Working in matrix environments including global teams as the One Team
Ability to work with middle degree of autonomy
Ability to understand scientific/clinical information
Manage a few projects in parallel
English conversation, read, and writing (TOEIC score ≥860)
Native level Japanese
Computers: Microsoft Outlook/ Word/ Excel/Power Point
Doctorate degree and 5 years of directly related experience
Background of biology

192

EU Regional Regulatory Affairs Manager Resume Examples & Samples

Serve as Regulatory Regional Manager EU, for one or more programs/projects and participate in global regulatory teams, as applicable
Develop and document regional regulatory strategies considering regional requirements, classification of changes, scheduling and priority setting
Contribute to the compilation of relevant high quality documentation for submissions in the region, including applications for new licenses, variations, license renewals, pediatric plans, orphan drug designations, product identifiers/names, and periodic reports according to agreed schedules while taking into account regional specific requirements. This comprises also related responses to questions on the submissions
Lead the preparation and contribute to briefing packages for Health Authority meetings
Responsible for the management of regulatory procedures like new license applications, renewal applications, variation applications, period reporting submissions, submissions required to fulfill regulatory post approval commitments and Scientific Advice meetings in the region
Act as a Subject Matter Expert on regional, regulatory procedures and Health Authority requirements
Develop and maintain effective working relationships with regional Health Authorities demonstrated by efficient communication and effective use of negotiation skills to achieve positive outcomes for CSL Behring
A degree in Life science (at least BSc) or Medical Science or Pharmacy, preferably with a post-graduate qualification. Degree e.g. in Drug Regulatory Affairs advantageous
At least 5 years of regulatory experience in a regulatory authority facing role, supported by additional pharmaceutical / industry experience
Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (relevant) regional Regulatory Authorities
Understanding of the scientific principles and technical requirements relevant to the development of a pharmaceutical product
Strategic and tactical thinking ability, complemented by a “hands on” operational approach and business planning orientation
Demonstrated ability to deal with rapid change, sound judgment and flexible approach to managing situations

193

Seeds Regulatory Affairs Manager Middle East & North Africa Resume Examples & Samples

Securing variety registration, in a timely manner according to business strategy, for both row crops and vegetable variety pipeline
Ensuring regulatory compliance concerning variety approvals in Monsanto's Row Crops and Vegetables divisions
Developing the company's variety registration strategy for the area and implement the EMEA and global processes in the region
Driving seed regulatory policy, anticipating changes in regulatory requirements and working towards workable seed regulation in the area
Representing Monsanto on relevant seed associations
Providing required support to the manufacturing and breeding organization to secure the company compliance
Issues management and incident response
Life sciences degree in plant breeding, plant sciences or related field
Relevant experience in the seed industry, plant variety registration, plant breeding, phytosanitary matter
Highly developed organizational skills; attention to procedure and detail; a proven ability to deliver results in a multi-disciplinary, team-based working environment; leadership
Agricultural and/or horticultural practice, seed variety or related regulations, product development, product management
Arabic language is a must. High standard of spoken and written English is also required

194

Regulatory Affairs Manager Resume Examples & Samples

Maintains registrations and licenses with federal, state, and international regulatory bodies, including ISO 13485 certification
Ensures company is in compliance with federal, state, and international regulations and ISO 13485 requirements
Acts as liaison with federal, state, and international regulatory agencies, Notified Body, and distributors during inspections and audits
Establishes, implements, and maintains the Quality Management System (QMS), and communicates requirements throughout the company
Holds management reviews and reports on the performance of the QMS to top management and Corporate Compliance, including need for improvements
Manages document, record, and change control processes, including document and part numbering and final approval of all documentation
Manages the internal audit and corrective/preventive action programs
Reviews design documentation, product labelling and IFU, and co-approves product release
Reviews and approves complaint investigations, non-conforming product reports, installations, receiving inspections, vendor evaluations
Establishes, implements, and maintains production work instructions
Assists with hardware validation
Conducts orientation training of new hires
Excellent time management and multitasking skills
Ability to understand federal, state, and international regulations and laws concerning medical devices
Ability to work with all departments within the organization
Knowledge of FDA QSR, ISO 13485:2003, MDD, and CMDCAS
Prior Quality Assurance experience desirable

195

Regulatory Affairs Manager, Usona Inst Resume Examples & Samples

Directs all regulatory processes requiring governmental approval by ensuring that all necessary applications are filed and maintained. Regulatory agencies include, but not limited to, the FDA, DEA, and state authorities
This position requires skills to lead communications with FDA and other regulatory agencies, and facilitate review and approval of submissions (including INDs and NDA)
Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standards
Track and follow through on required mandatory report submissions (e.g., initial IND application and annual reports, MedWatch reports)
Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
Proactively identify and address compliance issues
Communicate regulatory information to team members, partners, and other stakeholders and ensure that the information is interpreted and relayed correctly
Sit on designated working teams and provide regulatory input and guidance to project teams, including quality control practices
Direct and assist research staff with FDA audit readiness, lead internal and external audits as appropriate
Develop and maintain Usona Institute’s standard operating procedures related to regulatory policies and procedures
Stay current in the areas of regulatory compliance and ethics, attend conferences and meetings as needed
Serve as main contact with US Food and Drug Administration (FDA), DEA and other regulatory agencies when needed
Understand and comply with any other legal, ethical, and regulatory requirements applicable to our business
Bachelor’s degree required, preferably in health sciences field
A minimum of seven years of experience in the pharmaceutical industry (small molecule) or a related area
Experience with DEA-regulated substances and clinical trials
Requires strong scientific or clinical research background
Demonstrated knowledge of regulatory affairs, such as 21CFR210/211
Track record of preparing original INDs, NDAs, and amendments in compliance with applicable FDA regulations
Familiar with a variety of the field's concepts, practices, and procedures, including FDA guidance documents and ICH guidelines and GCP
Ability to manage complex projects and timelines
Experience with eCTD format and submissions process and procedures
Critical thinking/ problem-solving, writing, oral communication and organizing skills a must. Presentation skills a plus. Relies on experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected

196

Regulatory Affairs Manager Resume Examples & Samples

First contact point for the Competent Authorities and Notified Body on field safety notifications, field actions, post-market surveillance queries or issues escalated from vigilance cases
Responsible for notifying Competent Authorities of serious device incidents
Registering/notification of Class I medical devices before they are marketed
Maintain appropriate licenses and certifications as required to assure access to all markets for ICU Medical products
Consultant in National/European legislation, keeping internal/external relations, working closely with the US based Regulatory team
Maintenance of marketed product documentation such as CE, DoC, labeling, TDS
Advise on advertising and promotional materials of marketed products if required
Set up and maintain a local surveillance system to evaluate incidents related to the products distributed and have access to all means for notification to Competent Authority
Support the commercial team and customers on Regulatory related questions
Fluent Dutch and English (additional Italian, French and/or German is a plus)
Strong drive to learn and expand knowledge
A (Bio)science or (bio)technical/mechanical background
5+ years of relevant working experience within the Medical device field
Profound knowledge of the MDD 93/42/EEC, ISO 13485, ISO 14971, MEDDEV 2.12, GHTF guidance
Experience as European Authorized Representative (EUAR)

197

Regulatory Affairs Manager Resume Examples & Samples

Effectively negotiate with, influence and maintain effective relationships with key stakeholders (e.g. regulatory authorities, consultants, distributor and licensors)
2。Maintain active communications with key government officials in Taiwan and providing Asia Regional professional support in respect to policy changes
Keep abreast of regulatory trends and competitor activities
Provide appropriate regulatory advice and preparation and review of regulatory strategies
Prepare and ensure cost-effective and timely registrations of high quality regulatory submissions for product registrations and variations
Management of variations to the conditions of supply of currently approved products
Provide appropriate advice to lot release requirements in Taiwan
Prepare for new product launch (Budget preparation and resource planning)
Contribute to the development and implementation of marketing programs
Participate in organizational and individual staff training programmes
Experience in pharmaceutical or related industry
Knowledge and understanding of Regulatory Affairs
Previous exposure to regulations/QA/PV
Marketing project and/or risk management experience

198

Regulatory Affairs Manager Resume Examples & Samples

Manages activities concerned with the submission and approval of various medical device or other categories of products to government regulatory agencies
Represents J&J at local Associations, Health Authorities and external organizations
Drives connection with Originating Companies, with good relationships and market access in Wave 2 Countries (US Desks, Supply Chain Liaisons)
Supervises the work of RA Sr. Specialists, Specialists and Associates
Responsible for performance evaluations and development plans
Focal point with Originating Companies as Wave 2 country to define strategies to plan regulatory filings for product approvals
Establishes and prepares appropriate regulatory filings for rapid and timely product approvals. Responsible for planning and organizing the team’s regulatory activities, including resource allocation and prioritization of all processes
Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.Responsible for submission of complex change to existing product license (critical supplier change/significant design change, alters primary registration, triage)
Manages tracking for renewal schedules to guarantee respective submissions before expiration dates in a timely manner
Gives regulatory support for marketed products
Supports divestitures strategy execution
Plans and executes strategy for acquisitions
Dashboard and performance indicators management
Maintains current and in-depth knowledge of Country and Worldwide Regulatory authority programs, policies and other critically important regulatory information that may affect the company's products and customers
Act as the link between functional areas and franchises with the rest of the RA team in the country-region
Develops a collaborative environment with other company´s and commercial areas
Responsible for people´s management processes and results within the reporting working team
Manages outsourced capabilities/temps & contractors to manage peak demand
Prepares submission status reports for review at meetings and by management
Supports the RA Sr Manager in the country in external environment activities to proactively shape the environment
Communicate with department members, other J&J personnel, government agencies in a professional, decisive, & articulate manner
Liaison with local regulator and OC to answer questions regarding product submissions in a timely manner
Maintains an appropriate level of professional competence through participation in industry association & continuing education programs
Makes recommendations & provide guidance to marketing, package engineering & regulatory personnel regarding label content (mainly for Drugs and Biologics)
Manages labeling review for packaging “nationalization” according to health authority approved text
Manages the regulatory aspects of new product registration for designated products with minimal direction from management
Participates with management in communications with local regulators, trade associations, and OCs
Prepares and leads training for junior regulatory affairs personnel
Assists in the preparation and control of department budget
Conducts reviews with local marketing and status updates with other local partners
Identifies the need, communicates to Quality and prioritizes GMP inspections as needed
Solid Knowledge of International regulatory processes
Excellent analytical capability, communication skills essential
Demonstrated ability to manage, motivate, and develop a staff of regulatory professionals
Must be able to work in a timeline-driven environment
Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive
Problem Solving - sorting through ambiguity to design solution plans; creative and compliant solutions to day to day issues
Ability to apply system knowledge to offer practical solutions to minimize compliance risk, while balancing business needs
Diplomatic interfacing with all levels of management
Networking - establish & maintain appropriate contacts in regulatory community
Advanced computer skills3002170608

199

Regulatory Affairs Manager Asia Africa Biotech Team Resume Examples & Samples

Lead the submission strategy and dossier preparation for new and existing products within the Asia Africa Region for import, cultivation, and renewal approvals
Provide the leadership and delivery of global regulatory dossiers in Asia Africa for Monsanto's products in collaboration with colleagues in the global Regulatory organization
Lead coordination of data package strategy with country and global teams and ensure the submission dossiers meet the country data requirements
Work as liaison between Country RAMs and US RAMs to ensure Asia Africa data requirements are met
Interact closely with country teams to ensure proper translation of guidelines into regulatory dossiers
Work with Country regulatory teams to assist in developing responses to questions from regulatory authorities, and develop other related documents (e.g., white papers, position statements, etc.) to obtain regulatory approvals in key export countries
Establish and maintain regulatory databases for submissions and correspondences
Minimum of a Master’s degree in Molecular Biology, Crop Science, Genetics, Plant Breeding, Plant Pathology, Biochemistry, Protein Chemistry, Toxicology or related scientific discipline
Minimum of three or more years of relevant experience in the agricultural, biotechnology, Regulatory/Government/Industry Affairs, pharmaceutical or related scientific based industry
Demonstrated ability to lead by influence across multiple functions
Proven ability for multi-tasking with strong project management skills
Ability to organize data and information effectively
Ability to write clear and convincing documents
Ability to work with customers to meet timelines and needs
Effective negotiation and persuasive skills
Very strong results orientation, resilience and ability to stay calm under pressure
Excellent written/oral communication and organization skills

200

Regulatory Affairs Manager Resume Examples & Samples

Education: The contractor shall possess a Master’s degree in Engineering, Science, Business Management, Systems Management, or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience
Tradeoff: The contractor shall possess a Bachelor’s degree in Engineering, Science, Business Management Systems Management, or a related discipline, as well as twenty (20) years of general experience and fifteen (15) years of relevant experience
Desired: The contractor may possess a regulatory affairs certification
The contractor shall possess training and experience in/with clinical quality assurance (QA), QA analysis and advice for GLP, GCP, GMP, biopharmaceutical facilities and manufacturing processes (to include BSL3), medical countermeasures development and licensing well as knowledge of the DoD 5000 systems acquisition process
The contractor shall possess expert knowledge in the development of medical products and systems, and shall be capable of applying this knowledge as required

201

Regulatory Affairs Manager, Vietnam & Myanmar Resume Examples & Samples

MS in life sciences or related field and 8+ years’ experience in food science and technology, nutrition, biochemistry, regulatory affairs in the food industry or PhD with 5+ years relevant experience including industry experience. Experience working with diverse cultures is a plus
Makes sound commercial decisions based on a thorough understanding of the global business
Knowledge of regulatory requirements to gain approval in Vietnam for food ingredients and dietary supplements
Proven track record of successful submissions and influence of regulations/regulators in food ingredients and dietary supplements
Honesty in defining gaps and failures, and find solutions to improve and/or find solutions to achieve business goals. Successfully analysis problems that require an in-depth understanding of the organization is a plus
Demonstrate strong influence on the success of future products and processes, and present influence to overall business interest (can be in non-technical/scientific manner)
Excellent skills in influencing and supporting others as a team
Excellent communication skills in English (verbally, in writing, and in presentations) and competency in Vietnamese. Working knowledge of another Asian language is a plus

202

Senior Regulatory Affairs Manager Resume Examples & Samples

Independently map out filing and regulatory strategy
Interact with HA division level and above
Actively involve into establishment and revision of regulations, guidelines
>8 years of regulatory affair experience including 5 years in managerial role in a multinational pharmaceutical company
Strong lobby/negotiation capability and excellent communication skill; excellent leadership with team spirit; high learning ability and willing to work under high pressure
Fluent English in verbal and written; good computer skill, good presentation skill.1700176696W

203

International Regulatory Affairs Manager Resume Examples & Samples

Generate regulatory reports to communicate registration activities
Interact with departments to generate protocols and reports that require in-country testing data for registration purposes
Stays abreast of IVD regulations and guidances, especially those relevant to in vitro Diagnostics
Maintain a "focused urgency" as required
Provide support to Post-marketing activities

204

Regulatory Affairs Manager Resume Examples & Samples

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Significant experience which provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience
Solid Regulatory background in global clinical trials

205

Consumer Health Care Division Regulatory Affairs Manager Resume Examples & Samples

Closely follow type testing process in order to finish registration test timely
Closely monitoring the regulation and product standard direction
Good in English
Bachelor degree in engineer related area
At least 5 years experiences in RA function in Healthcare industry

206

Regulatory Affairs Manager Resume Examples & Samples

Assures ingredients, formulas and packaging materials are in full compliance with laws and regulations in countries where they are sold
Issues mandatory labelling for products and approves final artwork and text for product packaging to ensure it meets or exceeds regulatory requirements
Monitors regulatory activities in assigned markets, determines current and expected regulatory status of new ingredients, packaging materials and additives; researches interpretations regarding the safety and acceptability of products and ingredients, and assures that SRA databases are up to date and contain the best current information
Participates on project teams, anticipates regulatory issues and works with legal counsel, consultants, suppliers, and trade associations and external partners to clarify and resolve these issues
Assists with the preparation and submission of documentation to regulatory agencies and other external bodies required to respond to regulatory inquiries, substantiate and approve claims and to gain approval of new ingredients
Performs the evaluation of packaging materials for compliance
Performs other regulatory related assignments as needed, including participation on SRA regional project

207

Regulatory Affairs Manager Resume Examples & Samples

7-10 Years of Experience with Bachelor’s Degree
5-8 Years of Experience with Master’s Degree
Minimum 3 Years of Experience in medical device company or similar regulated industry
Previous Manager Experience
Previous Regulatory Affairs Specialist Experience including Pre-Submission, IDE, PMA and 510(k) Submissions, CE Mark and other countries. In addition, Review and Approval of Advertising and Promotion materials
Proficiency in FDA Regulations and other Notified Body Regulations
Medtronic Product Experience and Knowledge

208

Senior Regulatory Affairs Manager Resume Examples & Samples

Influence Corporate Regulatory Affairs to ensure the creation of pan-Medtronic tools necessary to enable RF compliance, such as RF GTINs
Work with CRHF R&D colleagues and direct reports to develop new limited process or best practices for RF (to match spectrum management authorities’ sparse requirements)
Project and manage a significant AOP budget for RF testing and certifications
Work with vendors worldwide to ensure in-country RF testing can occur as needed in every country that is requested by CRHF Marketing
Represent CRHF on Telecommunications Regulatory Sub Council (TRSC), leading the group in the area of process or best practices
Work with direct reports to develop successful RF regulatory strategies to ensure timely product approvals
Ensure that negotiations with spectrum management authorities (SMA) occur in a timely manner. This requires influencing the TRSC Advocacy team members and/or working with the authorities directly
Able to take on complex issues and tenaciously execute plan regardless of obstacles
Provide management and leadership to the RF Regulatory Affairs organization in such areas as personnel, objectives, projects and responsibilities. Contribute to the development and implementation of business unit strategic and operating plan
Provide work direction, training and regulatory advice to direct reports and other members of the regulatory department. Interview and hire staff as necessary. Review personnel decisions to ensure harmony with overall department goals
Review submissions of less experienced regulatory staff and coach as necessary to ensure continuing development of regulatory skills
Keep Senior Management informed of regulatory status of products and significant RF regulatory issues, and update them about new developments
Direct submission negotiations with SMAs as needed (depending on level of experience of Regulatory Affairs Specialist), including pre-submission identification of requirements and strategy and post-submission negotiations to ensure timely approval
Maintain proficiency on all countries regulatory requirements and develop and maintain rapport with SMA reviewers, group leaders and ancillary personnel
Ensure the support by regulatory staff of the international regulatory managers
Conduct annual performance reviews. Assist with setting of objectives and professional development of staff
Provide continuing regulatory education and dissemination of RF regulatory information to the development, marketing and clinical groups
Four-year degree, preferably in a medical or technical related field and five or more years project / personnel management experience, preferable in regulatory/quality system environment
Minimum 7 years experience in Regulatory Affairs for a medical device company
Minimum 5 years experience as a Manager
Submission related word processing skills
Experience at formulating successful regulatory strategies that meet aggressive preparation and approval timelines, while maintaining the highest level of quality
Knowledge in Radio Frequency
Proven expertise in all aspects of Regulatory Affairs; Strategy Planning, Submission Prep, All Phases of FDA Device Law/Regulations, WW Regulatory Requirements/Procedures, Project Management, Negotiations, Medtronic Product/Design/ Development Systems

209

Regulatory Affairs Manager Resume Examples & Samples

B.A./B.S. Degree medical or technical related field
5+ years medical device regulatory experience with a B.A./B.S
3+ years medical device regulatory experience with a Master’s degree
Knowledge US medical device regulations
Knowledge of EU medical device directives
Strong understanding of FDA standards
Management experience in regulatory/quality system environment
Proven leadership/credibility with Medtronic and Regulatory Agency personnel
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to use a computer, and communicate with peers and co-workers

210

Regulatory Affairs Manager Resume Examples & Samples

A bachelors degree in a related science or engineering discipline required. A related advanced degree is preferred
Extensive knowledge of global regulatory for class II and class III medical devices, including orthopedic devices required
Ability to operate effectively in a culturally diverse organizational structure, in addition to working independently with limited management oversight, is required
Experience working globally and with global teams
Multi-site experience, in a mid to large size company
PMA/IDE experience
Proven expertise in all aspects of Regulatory Affairs; Strategy Planning, Submission Prep, All Phases of FDA Device Law/Regulations, Global Regulatory Requirements/Procedures, Project Management, Negotiations, Product/Design/ Development Systems
Demonstrated advanced software skills including Microsoft Word, excel, database and Adobe software skills
Regulatory Affairs Certified (RAC)
Knowledge of statistics and statistical methods
Experience with orthopedic devices
Experience with disposable medical devices
Clinical knowledge of orthopedic devices

211

Regulatory Affairs Manager CMC Resume Examples & Samples

In your role you represent the department in international project teams and provide CMC regulatory advice regarding global regulatory requirements, CMC submission strategies and opportunities for seeking scientific advice from health authorities
You will guide project teams to prepare high quality global registrations documents and responses to health authority requests and ensure that timelines will be met
You will plan, define, review and compile global Module 3 documentation for Clinical Trial Applications and Marketing Authorisation Applications
Furthermore, you will review CMC documentation for in-licensing products
You represent the department in international project teams and provide regulatory advice regarding global CMC regulatory requirements, CMC submission strategies and opportunities for seeking scientific advice from health authorities
You plan, define, review and compile global Module 3 documentation for post approval CMC activities (e.g. CMC changes and renewals)

212

Regulatory Affairs Manager Resume Examples & Samples

A degree in a scientific discipline or equivalent is desirable
Minimum of 5 years’ experience in the pharmaceutical, medical device, biotechnology and/or cosmetic (recent) industries desired
Candidates should understand the essential framework of regulations and guidelines pertinent to their exposure areas

213

Regulatory Affairs Manager Resume Examples & Samples

Lead the preparation and submission of documentation to regulatory agencies and other external bodies required to respond to regulatory inquiries, product claims, import/exports, and general issues
Monitor FSMA and regulatory activities in assigned markets, determines current and expected regulatory action and works with teams to develop robust compliance plans
Research interpretations regarding the safety and acceptability of products and ingredients
Participate on project teams, anticipates regulatory issues and works with legal counsel, consultants, suppliers, and trade associations to clarify and resolve regulatory concerns
Develop business position statements on emerging social media issues and environmental, sustainability and/or food safety concerns
Designated interface with legal and regulators regarding recalls, licensing, food safety issues and concerns
Coordinate regulatory expectations and compliance activities between Reinhart Food Service, Suppliers, Customers and Trade partner groups as they relate to Reinhart’s products and QFS Systems
Work cross-functionally to provide domestic and selective international regulatory guidance
Support Corporate Standards and Food Safety and Quality Assurance teams in regard to specialized knowledge in relation to FSMA regulations, allergens, product claims, product labeling, etc
Assure that regulatory databases are up to date
Provide regulatory guidance regarding special situations (e.g. floods, fire, hurricane, power outages)
Work with locations to create strategies, policies and SOP’s that ensure regulatory requirements are met
Communicate cross-functionally on current and emerging regulatory issues and opportunities, outline potential impact on products and systems, and recommend mitigation activities, as required
Support product recalls and withdrawals, including during 24/7 night and weekends
Represent company in interactions with customers, suppliers, trade partners and sales support requests
Provide documentation support, regulatory guidance, and compliance reviews specific to new food product concepts and labeling
B.S. in Food Science, Nutrition or related field required
Minimum of 5 years of Regulatory Affairs experience in the food industry
Strong Regulatory knowledge of FSMA, FDA, USDA Regulations
Excellent collaboration, leadership and teamwork skills
Ability to succinctly decipher technical material and regulations into simple guidance
Strong interpersonal, organizational, verbal and email communication skills with professional demeanor
Ability to independently research regulatory issues and lead/influence/educate resolution or opportunity
Good knowledge of food product development and processes
Demonstrated ability to handle multiple project and timelines simultaneously
Detail oriented and highly self-motivated
Regulatory knowledge of food-related international regulations

214

Senior International Regulatory Affairs Manager Resume Examples & Samples

Manage a team of 3+ professionals
As required act as liaison with government
Requires familiarity with new product development systems; a working knowledge of all U.S. regulations that affect Class II and Class III devices; a strong working knowledge of global regulations; excellent writing and verbal communication skills; and strong problem-solving and analytical ability
Ability to work collaboratively in a fast moving highly matrixed organization

215

Device Regulatory Affairs Manager Resume Examples & Samples

Track, compile, and maintain full regulatory applications
Maintain timelines for full regulatory documents
Provide regulatory advice and guidance to ensure compliance with appropriate national/regional government regulations and requirements (including review of protocols, drug development plans, study reports, and marketing application components)
Interact with appropriate national/regional government regulatory agencies; and
Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges
Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges; and
Coordinate interactions and timelines with outside vendors regarding regulatory documents
Master’s degree or equivalent and 5 years regulatory affairs experience or Bachelor’s degree or equivalent and 7 years regulatory affairs experience
Demonstrate ability to independently track, compile, and maintain full regulatory applications to ensure compliance with governing regulations and guidance
Demonstrate ability to interact with appropriate national/regional government regulatory agencies; and
Demonstrate ability to write departmental Standard Operating Procedures

216

Emerging Market Regulatory Affairs Manager Resume Examples & Samples

As Regulatory Affairs Manager Emerging Markets, you are the interface and contact partner for the teams from Emerging Markets Regulatory Affairs (RA) and functions within Global RA and other cross-functional stakeholders
You are an integral member of the Regulatory Affairs sub team, responsible for a particular therapeutic area
With your expertise you contribute to the delivery of robust regulatory strategies for the Emerging Markets to enable timely submissions and approvals aligned with the global development plans
You are involved in Regulatory Intelligence information gathering related to Emerging Markets and the impact assessment to ensure this information is globally shared, evaluated and implemented as per existing procedures
As an expert on Emerging Markets requirements in general and for the assigned therapeutic areas you represent the Emerging Markets Region/allocated sub-region at relevant project meetings

217

Global Regulatory Affairs Manager Resume Examples & Samples

As a Team Member Regulatory Affairs (RA)/ EU sub-Team Member RA you will develop and implement sound regulatory strategies and provide regulatory advice to support assigned projects in development and in product maintenance optimization strategies
With your expertise you will initiate, guide, coordinate and conduct interaction with health authorities in cooperation with the RA functions in other countries
You define, provide guidance and input as well as review of key regulatory documents like protocols, clinical trials reports, CTA/IND, PIP applications, or core dossier elements
Furthermore, you prepare and manage applications including response phase for example MAAs/NDAs/BLAs, extensions, variations, CTAs, or PIPs

218

Senior Regulatory Affairs Manager Resume Examples & Samples

RAC Certification and/or a Masters in Biomedical Regulatory Affairs are also desirable
Minimum of 10 years’ experience in the pharmaceutical, medical device, biotechnology and/or cosmetic (recent) industries desired
Must have a basic grounding in GLP, GCP and GMP
Must have strong interpersonal and communications skills with strong English language ability
Must be articulate and able to communicate effectively with employees at all levels of the organization, as well as with key individuals outside the organization. These outside contacts may include Philips personnel from commercial organizations, dealers-distributors, and consultants

219

Regulatory Affairs Manager Resume Examples & Samples

Develops relationships with policy makers at key regulatory agencies
Works with peer institutions to develop coordinated strategies
Identify and track rule making situations that may have material significance to the bank
Work with internal constituents to develop plans to match business objectives
Represents Regions at Federal agencies, Congress, trade associates and public events
Advises Regions' executives and subject matter experts on the political landscape and strategic analysis of potential impact
Ability to foster effective relationships and networks with others

220

Regulatory Affairs Manager Resume Examples & Samples

Coordinate and submit on-going regulatory documents to institutional and external IRBs. Track and report annual IRB renewals, submission of annual reviews, modifications to existing protocols, Serious Adverse Events (SAEs) and protocol deviations to the appropriate SCCA group, IRB or sponsor
Ensures SCCA meets its regulatory obligation for the conduct of recombinant DNA research by administratively overseeing the SCCA Institutional Biosafety Committee (IBC) and any related requirements
Maintain and update all required regulatory documents including but not limited to FDA Form 1572 and/or 1571, protocol signature page, Investigator Brochure (IB), financial disclosure, laboratory accreditations , laboratory reference ranges, investigators’ and research staff CVs, medical licensures, and related forms per sponsor or federal requirements
Maintain study-specific regulatory files and location-profile filing system per FDA guidelines
Oversee submission and maintenance of safety documents including Investigational Drug Brochures, IND safety reports, and SAE reports
Independently assess prioritization of all regulatory affairs to include protocol submissions, clinical trial regulatory maintenance, regulatory document collection, submission of protocol violations, contact of Sponsors and IRBs to ensure timely IRB approvals in addition to other tasks. Maintain knowledge of all RI-led clinical trials to ensure regulatory compliance
Partners with the clinical research management to analyze clinical research protocols to assess regulatory requirements and anticipate/resolve any potential regulatory issues
Supervises and leads quality assurance efforts in regards to research regulatory compliance
In collaboration with RI medical and administrative leadership, may manage and track aspects of the study selection/feasibility process for all industry-sponsored trials
Works with clinical research leadership and research finance on contracts, budgets and billing as needed
Manages communication with pharmaceutical sponsors, cooperative research groups, the IRB, FDA, NIH, NCI, CTEP, and other regulatory bodies to facilitate approval of research projects
Organizes, prepares, and submits periodic and annual progress reports to the FDA/NCI/ NIH/CTEP/IRB and/or other agencies as required
Audits current data systems to assure integrity of the system (timeliness of data entry, accuracy, reliability, and validity of the clinical research data, adherence to regulatory requirements). Takes corrective action as needed
Coordinates the development of investigator-initiated protocols, including: preparing drafts, managing appropriate internal reviews, implementing revisions, and version control
Liaison for department-wide IT initiative to improve electronic data capture, clinical trial management, and regulatory/eIRB
Develops and regularly reviews regulatory policies and standard operating procedures (SOPs)
Provides leadership for regulatory staff, promotes professional growth and participation in shared decision making
Lead/participate in regulatory components of internal audits (including IRBs) and external audits (Sponsor/FDA) and will have responsibility for associated preparation, execution and corrective action tasks
Prepares and submits regulatory documentation including IND/IDE applications, annual reports, Serious Adverse Event reports, etc. to the appropriate regulatory agencies including the U.S. Food and Drug Administration (FDA)
Oversees the development of clinical trial consent forms in accordance with CFR and FDA guidelines, ensuring all appropriate “Elements of Informed Consent”. Translate complicated research protocol requirements into language easily understandable by research participants
Participate in reviewing and assessing new research projects and assist investigators and RI leadership with feasibility analysis from a regulatory perspective. Lead sponsor’s qualification visits with the principal investigator
Responsible for overseeing the conduct of quality assurance audits of RI trials and ensuring compliance with study protocols, program SOPs, policies, GCP and FDA regulations. The QA procedures include regulatory and clinical compliance reviews of trial activities such as source document verification against data capture systems, consent documentation compliance, and AE, SAE and concomitant medication review. Prepare audit reports and present process improvements to RI leadership and internal collaborators. Develop and implement process improvements via policy and procedure development and training programs
Lead RI SOP development and implementation by drafting, reviewing and maintaining SOPs, policies and procedures
Prepare interim reports and assist with analysis
Work in collaboration with other Research Integration Managers and staff to execute the research mission of SCCA and support the Associate Director and Director in all RI initiatives
Demonstrated leadership abilities through prior work experience. Multiple years of prior direct staff supervision including staff mentoring and performance management as well as daily operations oversight strongly preferred
Computer literate to include working knowledge of Microsoft Office Programs (Word, Excel, Access and PowerPoint), E-mail applications (i.e. Microsoft Outlook), and SharePoint. Experience with Clinical Trial Management Systems (CTMS) preferred
Requires experience with medical terminology
Knowledge of protocol and consent form development
Excellent knowledge of the regulations established by the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP), International Conference on Harmonization (ICH), and Good Clinical Practice (GCP) Guidelines
Experience working with Pharmaceutical Sponsors, Cooperative Groups, FDA, National Institutes of Health (NIH), National Cancer Institute (NCI), and Cancer Therapy Evaluation Program (CTEP) representatives
Demonstrated communication, leadership, and team building skills: evidence of this should include dealing well with people, effective problem solving, appropriately confronting issues, motivating others as individuals and as groups, planning, organizing and directing the activities of others
Demonstrated skill in working with minimal supervision. Effective written, verbal communication
Ability to manage change, promote positive interpersonal relations, and has a well-established understanding of the healthcare culture
Strong organizational, planning, budgeting and customer service skills
Must have excellent presentation, facilitation, and influencing skills
Self-starter with strong sense of ownership and ability to work autonomously while keeping leadership informed of progress and barriers to success
Excellent creative and conceptual thinking abilities
Ability to gather information from multiple sources in order to gain a thorough understanding of needs
Ability to handle multiple tasks, deadlines and requests in an unpredictable environment while utilizing appropriate time management skills
Ability to innovate, develop or adopt best practices and manage through change
Ability to successfully navigate in complex organizational structures to complete work

221

Regulatory Affairs Manager Resume Examples & Samples

Attention to detail and quality of documentation
Familiar with computers and their applications, e.g. Word, Excel, Power Point
Excellent negotiation skills
Expertise of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management
Analytical and investigative skills
Expertise in at least one of the specialty areas: preclinical, clinical or CMC, etc
Ability to act as liaison with other departments

222

Regulatory Affairs Manager Resume Examples & Samples

Lead and actively participate in product registration projects on defined global markets
Several years of experience in global IVD or medical device product registrations
Experience from Asian, East European and/or South American countries
Experienced of regulatory aspects regarding marketing material and other product labeling
Fluent Swedish and English, both spoken and written
A scientific (or similar) university degree

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