Regulatory Affairs Associate Resume Samples

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M Tremblay

Makenna

Tremblay

7328 Blaise Stravenue

Chicago

+1 (555) 687 0422

7328 Blaise Stravenue

Chicago

Phone

p +1 (555) 687 0422

Experience Experience

Houston, TX

Regulatory Affairs Associate

Houston, TX

Leuschke LLC

Houston, TX

Regulatory Affairs Associate

Providing Regulatory advice and support to internal and external customers from development through full life cycle management
Be willing to work with a Lean team and wear multiple hats to create smart strategies for regulatory submissions and an expanding Quality Management System
Provide regulatory leadership for new product development and change management activities
Coordinate/manage the review and approval process of senior management of the company for all regulatory submissions on company development compounds
Participates in activities to create and improve regulatory processes and systems
Establishes confidence in one’s regulatory abilities and develops long-term trusting relationships
Provide technical customer assistance

Phoenix, AZ

Senior Regulatory Affairs Associate

Phoenix, AZ

Lubowitz-Hessel

Phoenix, AZ

Senior Regulatory Affairs Associate

Prepare and execute regulatory strategies/plans. Provide ongoing support to product development teams for regulatory issues/questions
At the direction of the Manager, Regulatory Affairs, perform training on regulatory-related matters with Acclarent personnel
Assisting with the development and implementation of global GSK regulatory strategy
Assist with label development and review for compliance before release
Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes
Assist in SOP development and review
Provide project management oversight (tracking, planning, timelines) for regulatory (MOH) submissions

present

Philadelphia, PA

Regulatory Affairs Associate Director

Philadelphia, PA

Yost and Sons

present

Philadelphia, PA

Regulatory Affairs Associate Director

present

Directs and oversees the work of regulatory professionals, including training, mentoring, and ensuring professional development
Serves as a departmental knowledge resource, counseling, advising, and training on all/most facets of departmental function
Responsibility for establishing prioritization of departmental tasks and projects
Provides guidance to members of the ARC regarding the current regulatory environment and regulatory considerations that may impact business activities
Establishes and/or approves Zimmer Biomet RA policy and procedures and ensures compliance with them; may include training RA team or cross-functional groups
Regulatory strategies, policies, cross-functional projects, and interdepartmental decision-making
Act as liaison for temporary/contract workers

Education Education

Bachelor’s Degree in Pharmacy

Michigan State University

Bachelor’s Degree in Pharmacy

Skills Skills

Strong software troubleshooting skills highly desirable
Pays close attention to detail, strong organizational skills, and ability to prioritize multiple projects
Strong verbal and written communication skills, Good computer skills with knowledge of Microsoft Office
Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects
Strong attention to detail
Experience in the medical device or related industry with demonstrated knowledge of scientific principles (e.g., R&D, Quality)
Good computer skills with knowledge of Microsoft Office
Demonstrates advanced knowledge and understanding of applicable regulations
Ability to enable and drive change
Displays good interpersonal skills and ability to deal effectively with a variety of personnel

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15 Regulatory Affairs Associate resume templates

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Regulatory Affairs Associate Resume Examples & Samples

2+ years of professional experience in Pharmaceutical industry
Exceptional writing and IT skills required
Advanced proficiency in Microsoft Word, PowerPoint, Outlook and Excel
2+ years of experience in Regulatory Affairs
Master's Degree in Regulatory Affairs

Senior Regulatory Affairs Associate Resume Examples & Samples

Bachelor’s Degree, preferably in a Life Science field
Minimum of 3-5 years
Pharmaceutical industry, laboratory, or clinical research experience
Intermediate proficiency in Microsoft Office Suite
Commitment to quality of all assigned projects
Excellent written and oral skills
Commitment to the regulatory affairs profession
Regulatory affairs experience

Clinical Regulatory Affairs Associate Resume Examples & Samples

Develop and oversee all promotional and contest initiatives of station
Directly supervise employees in the Promotions Department including but not limited to hiring, training, disciplining and appraising performance of employees
Write, create and produce on-air promotional
Plan and develop station promotions
Supervise stations contests including originating or adapting ideas, arranging prizes and listener events
Maintain accurate records of contestants, and ensure contests are conducted in accordance with FCC regulations and law
Represent station at community events and promotions
Coordinate activities of other departments involved in production of promotions and remotes
Maintain stations prize closet, inventory of station premiums and inventory and control of station banners
Prepare affidavits for clients attesting to the promotional announcements aired for a particular campaign
Coordinate all prizes and winners and make sure prizes are available for front desk distribution
Handle all release forms to insure 1099’s are in order for distribution
College degree in Communications or Marketing preferred but not required
Minimum two years’ experience in broadcast marketing, public relations or related field
Knowledge of all FCC rules and regulations related to broadcast marketing
Ability to work under tight deadlines
Ability to work well with others
Ability to handle stress and related pressures
Valid driver’s license and dependable transportation
Ability to frequently lift and/or move in excess of 50 pounds

Regulatory Affairs Associate Resume Examples & Samples

2-3 years industry experience in the pharmaceutical or biotechnology industry
Proven ability to manage critical projects with a minimum of supervision
Prior experience compiling filings for FDA submissions is required with the ability to successfully manage projects to deadlines
Prior experience in a product development role
Proficient with computer and standard software programs
Strong interpersonal and communication (written and verbal) skills
Demonstrated good judgment
Capable of working with an interdisciplinary team

Senior Regulatory Affairs Associate Resume Examples & Samples

BA/BS in a scientific, healthcare or related field or equivalent experience. Advanced degree preferred, but not required
At least 1-3 years of relevant regulatory affairs and drug development experience or equivalent biopharmaceutical experience with a strong emphasis on regulatory affairs and drug development
Knowledge of US FDA regulations and guidelines on drug development and the approval process for NDA/BLAs as well as postmarketing supplements
Strong written/verbal communication skills
Well organized with attention to detail

Regulatory Affairs Associate Resume Examples & Samples

2 to 3 years of experience
Regulatory Affairs or related coursework
Proofreading abilities
Working knowledge and experience with 21 CFR, US FDA guidance, ICH guidelines
Strong computer skills in order to learn new programs as quickly as possible
Experience in MS Word, Excel, Outlook and Adobe Acrobat
Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment
Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects
Excellent written and verbal communication skills and interpersonal skills
Ability to communicate effectively and collaboratively as part of a team in a respectful manner
Ability to interface with professionals domestically and abroad
Ability to work independently, self-starter
Good problem solving skills and analytical ability

Regulatory Affairs Associate Resume Examples & Samples

Preparation and submission of regulatory documents for new marketing authorisation applications, variations and renewals
Regulatory manufacturing compliance activities including review of change controls, maintenance of compliance documentation and notices of regulatory approval
Review and approval of product artworks
Review and approval of raw material / finished product / packaging material specifications and other controlled documents for compliance with the Marketing Authorisations
Support to the Regulatory Affairs department, including archiving of regulatory dossiers and correspondence
Maintenance of tracking databases in relation to the status of ongoing regulatory activities
Extensive experience working in a pharmaceutical regulated environment
Over 2 years' experience in a similar role with a major focus in Regulatory affairs

Regulatory Affairs Associate Resume Examples & Samples

Maintain an ellent understanding of global medical device
Communicates country/region specific regulatory requirements to the regulatory specialists/ managers
Advise all functional units across engineering, marketing, operations and quality of the requirements in each target market
Ensure the outputs from the individual functional units meet the applicable regulatory requirements
Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as required
Maintain registration information including license numbers, expiration dates and more, including re-registrations
Communication of the clinical requirements for regulatory registrations for the product and working as part of a cross functional team to ensure that they are adequately addressed
Co-ordinate multiple projects at one time and provides regular reports to regulatory management and others as required
Prepare and submit regulatory documents for new marketing authorisation applications, variations and renewals
Review and approval of product artworks, raw material / finished product / packaging material specifications and other controlled documents for compliance with the Marketing Authorisations
Extensive experience working in a medical device regulated environment
Third level Qualification in Science/Engineering
5 years experience in a regulated industry in a similar role
Good communication and inter-personal skills
Proven problem-solving skills and self-motivated

Commercial Regulatory Affairs Associate Resume Examples & Samples

Bachelor’s Degree with pharmaceutical industry work experience
Process orientation and management skills
Excellent project management skills including meeting facilitation, organization and time management
Microsoft Office, including Excel, Word and PowerPoint proficiency

Regulatory Affairs Associate Resume Examples & Samples

Lead risk management and design control process from a regulatory perspective
Ensure company operations are fully compliant with product licences and are updated accordance with the relevant guideline and directives
Compilation of global regulatory submissions
Co-ordination of the licenses for controlled substance and others documentation
Conduct internal and external quality audits
Keep up to date with industry related regulatory legislation and trends

Senior Regulatory Affairs Associate Resume Examples & Samples

6+ years of relevant work experience; 6+ months of prior experience managing interns and/or external consultants
Bachelor's Degree in a Natural Sciences-related field
Solid knowledge of Regulatory Agency organizations
Solid negotiating and influencing skills
Experience with FDA registered products such as medical devices and OTC drugs
Prior experience working in the Pharmaceutical, CPG, and/or Healthcare industry
Bilingual (English and Spanish)

Regulatory Affairs Associate Resume Examples & Samples

Bachelor's Degree in chemistry, biology or other related scientific discipline
2-3+ years in the pharmaceutical industry, with at least 1-2 years of Regulatory experience supporting US FDA pharmaceutical products
Proficiency in eCTD Publishing Software
Good understanding of regulatory requirements for ANDAs and 505b(2) applications
Good knowledge of FDA guidelines, ICH and related guidelines
Demonstrates a basic understanding of pharmaceutical drug development
Proficiency in Microsoft office and XML programs
Previous R&D (analytical or formulation) experience
505b(2) experience

Regulatory Affairs Associate Resume Examples & Samples

Provide regulatory leadership for new product development and change management activities
Compile, prepare regulatory documents (summary technical documents, essential requirements checklists, 510(k)’s, Biologic License Applications, European Union-EU design dossiers)
Develop product registration strategies that enable accelerated product development through knowledge of Food and Drug Administration (FDA) regulations, EU Directives, International Organization for Standardization (ISO) standards, etc
Provide support on special regulatory assignments relating to the development of internal procedures, training, interpretation of existing and new international regulations
Plan and execute global product registrations on time
Review product design, label, manufacturing location or other changes for impact on product registrations
Review product labeling and claims for compliance to applicable regulations
Assure regulatory compliance in all activities
Bachelor’s degree or higher in a Science or Engineering discipline from an accredited institution
Minimum of three (3) years of experience Regulatory Affairs related to combination products, biological products and/or medical devices
Bachelor’s degree or higher in Pharmacy, Engineering, Biological Sciences, Chemistry or related discipline from an accredited institution
Minimum of five (5) years of regulatory experience interacting with FDA and/or other regulatory bodies worldwide
Demonstrated technical/scientific skills, excellent technical communication skills (oral and written), effective interpersonal and organizational skills and the ability to meet deadlines
Demonstrated history of accomplishments and contributions to business in previous assignment in support of regulated products
Proven project leadership and excellent communication skills
Knowledge of or experience with tissue and/or biologic regulations
Regulatory Affairs Professionals Society (RAPS) Regulatory Affairs Certification (RAC) certification
Bilingual (English and Spanish or Chinese-Mandarin) a plus

Regulatory Affairs Associate Resume Examples & Samples

The Regulatory Affairs Associate will be a member of the local regulatory affairs department within Johnson & Johnson Medical, with responsibility for regulatory aspects of the assigned product portfolio/s
Preparation of submissions to the local health authority for new products and variations to existing products in line with Marketing launch plans, with guidance from senior regulatory colleagues as necessary
Build constructive relationships with the local health authority by compiling and submitting high quality submissions and providing prompt responses to questions
Maintain an awareness of new legislation, policies and guidelines impacting the assigned product portfolio
Contribute to continuous review and improvement of processes within the Country Regulatory Affairs (PA) department to ensure consistent, efficient and effective practices across the team
Participate in discussion groups for the industry association, as required
Contribute to PA Team meetings to learn from colleagues, share experiences and best practice
Assist PA colleagues in supporting other product portfolios or PA activities, as required
Establish meetings with Marketing colleagues to share information about new products, line extensions and changes to currently approved products and review timelines for product approvals

Regulatory Affairs Associate Resume Examples & Samples

Blue Sheet inquiries: enter data into Firm’s system, research options, approve all inquiries via Electronic Blue Sheets Management System, maintain strict timeline for entry and approval of Blue Sheet inquiries, print and maintain daily Blue Sheet entry records for audit purposes and adhere to document retention schedule per industry guidelines
Assist with Self-Regulatory Organizations (SRO) examinations of Scottrade
Assist with regulatory inquiries
Create written reports to be reviewed by the Regulatory Supervisor
Knowledge of financial markets and brokerage industry
Excellent research/problem solving skills
Quick and accurate typing
Business writing skills
Ability to analyze documents
Ability to manage time and prioritize tasks
Intermediate level proficiency with Microsoft Word, PowerPoint, Excel, and Outlook
Foster company success through a professional appearance, being courteous to regulators, customers and all Scottrade associates and by having a positive attitude
High school diploma or equivalent combination of education and experience required. Bachelor’s Degree in Business or related field preferred
2+ years brokerage experience preferred. Online brokerage experience preferred
Operational experience at a securities firm preferred

International Regulatory Affairs Associate Resume Examples & Samples

Provide international regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents.)
Provide general support for international regulatory team and projects, as needed
Coordinate the generation and maintenance of product International Dossiers and all related supporting documentation for international product registrations
Supply International Dossiers and other related information (e.g. Certificate to Foreign Government, etc.) to Bard IBCs; help coordinate and respond to inquiries from Bard IBCs through use of various internal systems, in order to facilitate new product registration, design change notifications, license renewals, and international marketing tendering and reimbursement processes
Research and respond to regulatory questions received from other division functions and outside sources (i.e., distributors, customs issues, etc.)
Coordination, review, and submission of product labeling for marketing outside the United States
Manage key internal systems, databases, and records
Understand the company’s products, surgical techniques and the use of implants and other devices
Bachelor’s degree required, with an understanding of healthcare industry
Associate: Minimum 0-3 years of international regulatory experience with medical device registrations (including CE Design Dossiers, Technical Files, and International Dossiers) and knowledge of compliance to international harmonized standards and international regulations (such as US FDA, MDD, Japan, Canada, Australia, Latin America and Asia Pacific)
Specialist: Minimum 3 years of international regulatory experience with medical device registrations (including CE Design Dossiers, Technical Files, and International Dossiers) and knowledge of compliance to international harmonized standards and international regulations (such as US FDA, MDD, Japan, Canada, Australia, Latin America and Asia Pacific)
Experience working with international businesses or cultures
Good oral and written communication skills – ability to work on cross-functional teams
Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience
Self-motivated by working independently and having the ability to take ownership of his/her responsibilities, the capability to work under time pressure, and to organize diverse projects in a timely manner
Ability to interact proactively and provide counsel and expertise to internal and external customers
Working knowledge of electronic documentation and information systems
Ability to travel approximately 10% of time
Professional certification preferred
Determination of level will be based upon years of experience & demonstrated knowledge/skills

Senior Regulatory Affairs Associate Resume Examples & Samples

A Bachelor's Degree in Science or Engineering and any 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
Demonstrated ability to lead from the front, connect with key internal and external stakeholders, ability to shape outcomes and deliver results
Previous people management experience would be highly advantageous

Regulatory Affairs Associate Resume Examples & Samples

2-3 years experience with Batch realse process – Must
BA in nutrition and similar OR IL Pharmacist + QP - Advantage
Regulatory Experience from Nutrition Importer company – Advetage
Understanding Quality System, and Quality Assurance
Strong computer skills – Excel, Word Good knowledge of local food regulations and EU directive
Team-player, able to working effectively with others to accomplish organizational goals
Able to build relationships and gain trust
High-level of accuracy

Regulatory Affairs Associate Resume Examples & Samples

Prepare regulatory submissions to FDA and other agencies, with direction from the Senior Director, Regulatory Affairs
Coordinate/manage the review and approval process of senior management of the company for all regulatory submissions on company development compounds
Electronically archive and catalog all submissions to and communications with regulatory agencies
Maintain Avid entries in clinical trial registries including clinicaltrials.gov
Provide administrative support to projects of other departments in the company, such as Quality Assurance, Chemical Development and Manufacturing, and Operations/contract management, as required
Associate’s or Bachelor’s degree in a relevant discipline preferred
Strong working knowledge of Microsoft Office software, especially Excel or database
Demonstrated excellent communication skills
Good interpersonal skills and desire to work in a team environment
Enjoys a fast-paced and hard-working environment

Regulatory Affairs Associate Resume Examples & Samples

3+ years experience in regulatory affairs, preferably in a regulatory operations group that prepares eCTD-compliant electronic submissions
Knowledge of IT systems and electronic submission requirements and processes
Possess very strong PC computer skills
Strong conceptual and analytical thinking skills
Able to take a project from start to finish while working in a constantly changing environment
Positive attitude and ability to establish and maintain positive working relationships
Comfortable in a fast-paced fast small company environment with minimal direction and adjust workload based upon changing priorities
Strong multi-tasking capabilities

Regulatory Affairs Associate Resume Examples & Samples

Participate in project team meetings
Manage timelines
Prepare/QC format documents to ensure Submission Ready
Perform bookmarking/hypertext linking of Documents
Perform pre/post publishing QC
Coordinate, compile, publish documents to support all submissions, including literature search and references
Maintain Submission Log (serial numbers)
Provide reminder notification letters to contributors for annual and DSUR reporting requirements
Partner with CRO/Vendor in the compilation and build of submissions
Maintain submission tracking spreadsheet for all components
Post completed submissions into File-hold and archiving repository
Participate in study closeout of TMF
Assist in the upkeep and maintenance of document repository and filing
Participate in the developing of working practice/job aids/SOP
Thorough understanding of CFR compliance, eCTD and submission compilation Requirements (FDA, Health Canada & EMA, including post-approval commitments)
Assisted or directly involved in the publishing and filing of IND/CTA/NDA/MAA
Knowledge of SPL and eCTD compilation
Ability to work as a team member and independently when required
Ability to Multi-task, and work in a diverse and complex environment
Highly computer literate

Bilingual Regulatory Affairs Associate Manager Resume Examples & Samples

Responsibility for the management of product registration activities with Merial team and third part
Responsibility for the management of Pharmacovigilance program (capas, training for Merial emploees in CAMCAR, report to regional and global teams), in accordance with corporate policies of Regulatory Affairs and Pharmacovigilance and according to the particularities and legislation required by country
Manage the activities of Regulatory Affairs in order to obtain and keep licenses, renewal and changes in registers of products; action plan with business, monitoring the implementation of this plan
Responsibility for the RA risk assessment process to support LCM activities in compliance with the current legislation and policies and in agreement with business and R&D teams
To answer the demands of regulatory authorities, as well processes and activities of the department in accordance with current policies and legislation
Management of information and regulatory dossiers in order to ensure confidentiality, information protection and agility to provide information
To identify and to anticipate developments and changes in the regulatory affairs policies or in agencies organization (Regulatory Intelligence)
Organize and update status for the registration process
Develop and maintain proactive relations with the authorities responsible for regulatory affairs in the CAMCAR region as well as steakholders and influencers
Represent Merial in local Committees and local Union
Implement and monitoring commercial quality package and strategy as AQO in CAMCAR region according regional /global alignmet
Veterinary DVM
Regulatory Affairs, pharmaceutical Industry
Relationship with regulatory authorities, management of processes
Fluency in English and Spanish is mandatory
Setting team structure focused on services to business
Establish culture of PV, AQO and implement programs in Merial CAMCAR
Collaborative performance of BO, RA strategy
Maintain and intensify constructive political relationship with agencies and union

QA Regulatory Affairs Associate Resume Examples & Samples

Interacts closely with Quality Systems, Quality Assurance, Regulatory Affairs and other groups to provide guidance and to ensure timely processing and completion of Change Controls
Coordinates cross-functional department meetings to prioritize Change Controls based on risk and business need
Reviews communications between Regulatory Affairs and the Regulatory Agency and compare to open Change Controls
Responsible for verifying and entering closure requirements for all Change Controls which includes knowledge and understanding of various site system processes and documentation (Wisdom, TevaDoc, EAM-Datastream, Oracle, Global Insight)
Maintains a current list of overdue and pending Change Controls and follows-up as appropriate to ensure completion in a timely manner
Provides leadership, training and guidance as required to end users to support daily functions
Trouble shoots and provides support as needed to business users answering questions concerning workflow processing/activities
Supports other Quality Systems/Regulatory Compliance activities as needed, such as Change Control, Auditing and APR assistance
Uses data trends to work with Site and Regulatory Affairs personnel to facilitate process improvements and lean concepts
Participates in cross functional improvement and process monitoring teams to mitigate unfavorable trends
Provides guidance and direction for Regulatory impact at the site level
Contributes to a motivating work environment, where superior performance is defined, supported, rewarded and recognized
Participates in external and internal audits
Review Applicable Standard Operating Procedures and other cGMP documents for process accuracy
Working knowledge of TrackWise and Regulatory Filing Requirments highly desirable
Detail oriented team player with strong interpersonal skills
Demonstrated working knowledge of cGMP and applicable regulatory requirements

Regulatory Affairs Associate Resume Examples & Samples

Route review materials to assigned PARC team members within established timelines
Schedule and manage PARC meeting dates/times and issue PARC agendas in a timely manner
Assure that all required activities leading up to PARC meetings are successfully completed within established timelines
Assure that all PARC review team comments are addressed and understood by PARC participants
Document any final changes to the materials and any outcomes of PARC discussions and route materials for final disposition
Review and approve material proofs to ensure that all PARC requested changes have been properly incorporated
Prepare and manage submissions to the US Food and Drug Administration Office of Prescription Drug Promotion (FDA OPDP) within established timelines
Proactively work with the responsible functions to assure that materials are expired or renewed in accordance with established procedures and timelines
BA/BS Degree
Three (3) to five (5) years of direct experience with processes related to the review and approval of prescription drug advertising and promotion materials preferred
Strong working knowledge of at least one electronic review system designed for advertising and promotion materials (Veeva Vault or ZINC) preferred
Working knowledge of the FDA 2253 submission process preferred
Ability to work under pressure and adhere to deadlines
Ability to work well in teams, including but not limited to peers and PARC membership
Demonstrated organizational and problem-solving skills

Drug Regulatory Affairs Associate Resume Examples & Samples

Prepare and complete the necessary documents (registration documents, Certificate of Pharmaceutical Product (CPP), Good Manufacturing Practice (GMP), Manufacturing License, etc.) for registration submission to local Head Authority in collaboration with Global Function (Pharma Development Regulatory (PDR), Pharma Technical Regulatory (PTR), International Product Partners (IPP)
Ensure regulatory compliance of Roche product registration process with BPOM regulation
Ensure that submission and follow up application to BPOM are performed in a timely and professional manner
Update the registration database and status (internal database, Global Product Regulatory System (GPRS)) in a regular basis
Support Marketing for tender documentation and supply chain for any queries related with registration approval status which will have impact to stock

Regulatory Affairs Associate, CMC & Labeling Resume Examples & Samples

Performs regulatory CMC and Labeling activities for assigned products and territories, including creating and updating quality sections of regulatory filings and review of quality submission documents to ensure consistency with related filings and regulatory requirements
Interacts with UT manufacturing and quality groups, contract and partner organizations, as necessary, regarding CMC and labeling regulatory issues
Collaborates with regulatory CMC and Labeling Manager on regulatory aspects of clinical and commercial product labeling for UT products
Ensures labeling remains current and consistent with regulatory filings
Assists in dossier preparation for partner companies in worldwide territories, ensuring accuracy and consistency
Proficiency with document management applications and MS Office
Diverse experience including biologics and drugs
Familiarity with operational systems (e.g., Master Control, LIMS, Adobe Illustrator)

Regulatory Affairs Associate Resume Examples & Samples

Support the compilation, development, submission, and maintenance of worldwide regulatory filings
Track regulatory project status and informational documents
Coordinate required documentation in coordination with CMC Team or Functional group
Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time
Interfacing with global Regulatory partners and internal cross functional teams
Attending relevant functional area and project team meetings as required
Bachelor’s or Master's Degree in a scientific discipline, or equivalent experience is required
Minimum of 2-4 years Regulatory Affairs experience required
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, DMF’s)
Attention to detail, organizational skills, and a demonstrated ability to prioritize multiple projects
Motivated, self-starter, able to work independently with minimal supervision

Regulatory Affairs Associate Resume Examples & Samples

Establish and/or maintain relationships with health authorities
Represent department at all appropriate cross-functional team meetings and communicated with key stakeholders as required to provide valuable regulatory expertise
Represent department at required meetings and maintained communications on an ongoing basis
Communicate key departmental information to internal and external customers according to the Regulatory Standards as required
Attend external seminars and workshops as required and shared knowledge between team members
Provide departmental training to Roche employee as required

Regulatory Affairs Associate Resume Examples & Samples

Develops and/or revises core labeling text in accordance with the listed drug or OTC monograph using appropriate reference or source documents, ensuring compliance with all applicable regulations and company or customer style requirements
Initiates and compiles required labeling documents for all ANDA submissions necessary for commercially marketed products. This includes but is not limited to coordination of side-by-side comparisons, SPL, and other required submission materials, as necessary
Prepares full responses to triggered FDA labeling deficiency letters for commercially marketed products or listed drug updates via a supplement or amendment
Initiates required qumas/trackwise change controls relevant to area of responsibility
Serves as back up to the RA Coordinator for the filing of all MLS’s and labeling samples as well as the updating of required revision lists needed for the Elizabeth plant
Interfaces with necessary Actavis Divisions (e.g., Purchasing, Marketing, QA, 3rd Party QA, Supply Chain, Medical Affairs, etc.) and customers to ensure accuracy with all OTC labeling
Works with site engineering groups on labeling specifications, when needed
Establishes and maintains a filing system for all artwork approvals and labeling samples accordingly
Ensures compliance with all SOPs
Assists in the creation and/or revision of SOPs, as appropriate
Shares responsibility in the maintenance of master labeling text, history, and source files
Maintains knowledge of regulations, guidelines, and standard operating procedures applicable to generic labeling
Electronically monitors the FDA website for updates related to Rx/OTC labeling and communicates to affected company individuals accordingly
Individual must be able to multi-task in a fast paced work environment
Must have exemplary oral and written communication skills
Must be organized with a keen attention to detail
Must have the ability to work independently as well as in a team environment
Have knowledge of US FDA regulations in regard to creation of labeling and processes for ANDAs and NDAs
Individual must have proficiency with XML, database, and word processing applications as well as Adobe Professional. Creative Suite software packages on a PC platform preferred but not required
PC, Microsoft Office Suite with a proficiency in Microsoft Word and Microsoft Excel
Adobe Acrobat Professional
Knowledge of SPL or equivalent XML application used to create structured product labeling preferred
Adobe Creative Suite (Illustrator and Photoshop) preferred but not required
Quark Xpress preferred but not required

Global Regulatory Affairs Associate Resume Examples & Samples

Develops and proposes regulatory success path to his/her line manager, ensuring appropriate and relevant legislative and technical elements are identified and incorporated utilising regulatory intelligence and experience
Is responsible for the efficient and effective, execution as well as project management of post approval maintenance regulatory activities, to ensure successful delivery of assigned projects and activities within agreed timelines
Utilises his/her understanding of stakeholders as well as product expertise to deliver excellent regulatory support and maintain the base of our business healthy
Develops good working relationships with peers and external contacts to become a recognised business partner, proactively guiding them through existing regulatory requirements and raising awareness of upcoming changes to legislation and regulatory environment directly affecting our daily business
Use regulatory expertise to assess the impact of changes proposed by business partner or by new regulation, identify and communicate related risk and feeds into action plans to manage them efficiently
Operates in line with departmental SOPs. Contribute to the quality assurance in place in the department (e.g. identify gaps, areas for training and improvement of processes.…)
Support as required other regulatory functions in developing, reviewing and/or executing regulatory activities to strengthen the efficiency and quality of the regulatory function globally
Drives, with the support of his/her line manager, his/her personal development to ensure outperformance. Develops his/her regulatory knowledge and contributes to RB regulatory intelligence
Working in a fast paced FMCG environment to ensure that a product remains compliant during its lifecycle post approval, with no loss of supply due to a regulatory reason
Keeping on top of the ever changing regulatory environment and ensure that all relevant information is applied to all necessary product and dossier updates
Meeting business / project deadlines in a pressurised environment
Building relationships across Regulatory, the wider R&D community, and supply functions within RB
Life Science or Chemistry degree, or equivalent
Regulatory or R&D experience with Consumer products ideally including proven expertise in registration, notification or maintenance of regulatory dossier or technical documentation
Technical Competencies

Regulatory Information Management Latin Support Regulatory Affairs Associate Resume Examples & Samples

Provides support for key Global Regulatory Affairs system to ensure that data aligns with industry best practices and existing Work Instructions; oversees quality of system data by identifying inconsistencies and suggesting resolutions; responds to system users’ requests for changes to data and questions relating to GRA systems and data
Is a contributing member of project teams as a representative for Regulatory Information Management Team (i,e, Support Lead)
Bachelor’s Degree in Life Sciences or Information Technology Preferred. MS in scientific or information technology discipline preferred
Experience in system support
5-7 years of Regulatory experience in the pharmaceutical industry, preferably with emerging markets (LatAm, APAC, CIS)
Experience with key systems supporting Regulatory activities: Regulatory Information Database, Submission publishing, Document Management systems
Experience working in Liquent’s InSight suite of tools desired
Regulatory publishing experience a plus
Must posess strong communication skills: Native fluency in English and in Spanish – mandatory; Native fluency in Portuguese desired but not required
Understanding of regulatory business processes
Working knowledge of regulatory requirements in the LatAm region desired
Understanding of the drug development process, generics and branded product development a plus
Ability and willingness to travel up to 20% within Latin American region as required

Regulatory Affairs Associate Resume Examples & Samples

Regulatory consultation
Regulatory compliance review/evaluation and gap analysis, including label, common technical documents, study report, and etc
Regulatory information collection and sharing
Cooperate with Clinical Lead and project team to set-up submission timeline and ensure the timeline is achieved as scheduled
Highlight common issues and address these with the team as a training need
Raise concerns with the Project Manager/Clinical Lead as appropriate
1year or above RA experience

Regulatory Affairs Associate Resume Examples & Samples

You will ensure timely request and submission to Health Authorities of all registrations items required for new products, new indications, line extensions , you will monitor the registration process in order to obtain regulatory approvals in due time
You will ensure timely submissions and approvals for upcoming product variations and product renewals
You will identify, request and follow up on required items for various regulatory activities
You will establish effective communication network with internal partners, interacting with various functions to support business, Business Development, Marketing, Pricing, Field Operations, and Supply Chain
You will use and implement appropriate SOP’s as required by Global Policies and local regulations
You will ensure the local label creation and packaging development will meet the local and corporate criteria’s
You will validate of packaging material at the LNCPP
You will support responses and issue resolution with regulators
You will archive documents (i.e. documents related to the quality aspects of whole sale activities, regulatory documents and others) according to the local regulation and global requirements
You will submit and follow up promotional materials and ensure timely approvals
You will timely declare events
You will prepare regulatory documentations for submission of tenders and importation programs

Senior Regulatory Affairs Associate Resume Examples & Samples

BA/BS in a scientific, healthcare or related field or equivalent experience; advanced degree preferred
At least 3 years of relevant regulatory affairs and drug development experience or equivalent biopharmaceutical experience, with a strong emphasis on regulatory affairs and drug development
Knowledge of US FDA regulations and guidance on drug development and the approval process for NDA/BLAs as well as postmarketing supplements

Quality & Regulatory Affairs Associate Resume Examples & Samples

Maintains complaint systems software and database
Analyzes, assesses and recommends improvements of the complaint management process
Prepares and submits medical device reports (MDR – FDA Form MedWatch 3500A, 21 CFR 803)
Analyzes and collaborates with a cross-functional team for market risk concerns through the compilation of Health Hazard Evaluations (HHE)
Participates in global Field Corrective Action and Recall Assessments and actions as required
Proactively distributes important product and/or medical information to relevant internal functions as necessary in support of product changes, safety issues and other sentinel events
Responds to both written and phone inquiries from Health Care Professionals, patients, and consumers
Disseminates relevant product complaint information within the organization on a consistent basis
Compiles statistical analysis of product complaints, prepares trend analysis, and contributes to management reports on the effectiveness of the complaint management system
Participates in risk analysis (e.g., establishing risk documents such as hazard analysis and FMEA)
Contributes to the development and maintenance of standard and custom product information responses in various formats to address vast array of inquiries
Participates in complaint process SOP writing and ensures that all employees are trained on the complaints processes
Participates in audits including, internal, US FDA, international agencies (including KFDA, JPAL, ANVISA, etc.) and ISO 13485
Plans, schedules, and completes projects in an aggressive “sense of urgency manner” consistent with corporate objectives
Participates in regulatory reviews, compliance gap analyses, implementation planning, and project management to ensure compliance with applicable regulatory requirements
Technical Skills – Must be able to review systems, processes and policies to ensure compliance with required quality system and clinical practices. Ability to make compliance decisions independently. Demonstrates understanding of manufacturing operations and scientific processes to assist with investigations, documentation, and reporting
Communication – Communicates effectively at all levels of the organization, including for purposes of facilitating audits, trainings, compliance and support corporate objectives. Expresses ideas clearly and simply both verbally and in writing. Promotes timely, ongoing flow of information to others. Communicates and listens effectively in order to develop and maintain key business relationships
Trust and Integrity
Problem Solving – Uses rigorous logic to solve problems. Probes all sources for answers. Looks beyond the obvious. Enjoys solving tactical and process problems. Applies appropriate theory and principles, expert judgment, and cross-functional expertise to address a broad range of complex problems
Decision Making – Quick to evaluate circumstances and seek necessary information or resources to secure a full understanding of the situation and/or requirements to be resolved. Makes timely, sound decisions based on analysis, wisdom, experience and judgment. Utilizes a high degree of creativity and latitude. Relies on extensive experience and good judgment to ensure that expectations are met and that business objectives are achieved
Adaptability – Must be very reactionary and adaptable to abrupt changes, arising issues, extreme time pressures, and other exigent circumstances while effectively maintaining the state of control required for the Complaints Handling System effectiveness. Embraces and adapts to change and demonstrates a willingness to learn. Reactionary and adaptable to abrupt changes, arising issues, extreme time pressures, and other exigent circumstances. Ability to respond quickly to change, and to prioritize actions to meet customer needs
Analytical Skills – Basic understanding of statistical tools. Proven ability to analyze and interpret data, to provide guidance, data driven decisions, and recommendations to internal customers, contract manufacturers, and external suppliers. Identifies and understands relevant trends, opportunities, needs, and market direction within the medical device industry
Computer Skills – Strong computer literacy. Highly proficient in MS Word, Excel, PowerPoint, Outlook required. High computer literacy as it relates to database management and generating electronic submissions
Minimum of 4 years of experience managing complaint management processes in the medical device or related industry required (e.g., QSR (21 CFR 820) and ISO/EC (MDD, ISO 13485))
Knowledge and understanding of FDA regulations and reporting requirements for medical device complaints, including MDR reports required
Knowledge of EU Medical Device Directives, Canadian Medical Device Regulations and other International Regulations strongly preferred
Knowledge of the requirements for international quality systems, including ISO 13485, MDD, Vigilance Systems, Notified Bodies, CE marking and IEC 60601 strongly preferred
Experience interacting with Health Care Professionals, patients, and consumers to complete and close complaint investigations strongly preferred
Experience with complaint management software systems and databases preferred
Basic understanding of statistical tools strongly preferred

Senior Regulatory Affairs Associate Resume Examples & Samples

Preparation, submission and maintenance of registration applications to the Therapeutic Goods Administration (TGA) and Medsafe (New Zealand) within the agreed timeframes assigned by the Regulatory Affairs Manager/Regulatory Affairs Team Leader
Review of existing registration dossiers to identify administrative and technical deficiencies that may influence the likely success or failure of the application
Propose/implement strategies to overcome deficiencies in the registration dossiers
Liaison with international parent and licence companies for the acquisition of documentation, information, product samples and responses to issues raised during review/evaluation of registration dossiers
Creation and review of Product Information and Consumer Medicine Information documents for registered products
Preparation of Artwork for submission and approval of artwork for final print
Responding to Medical Information enquiries
Preparation of the applications to the Pharmaceutical Benefits Branch for product reimbursement
Provision of guidance, training and coaching to junior Regulatory Affairs staff; and
Provide strategies with respect to necessary bioequivalence studies; to organize local bioequivalence studies, and preparation of such studies, eg provide guidance on study design and study conduct to international study centers; assisting HQ in conducting global BEQ studies where applicable

Regulatory Affairs Associate Resume Examples & Samples

Provide input to Global and local RA strategies. Assess potential risks and provide input for product development plans. Review regulatory project plans/protocols and reports to meet Canadian regulatory requirements in collaboration with Global and local partners
Prepare high quality submissions including NDS, SNDS, Medical Device Licence Applications, CTAs, etc. according to current Health Canada requirements. Collaborate with global and local teams to provide accurate responses to stakeholders within set deadlines
Assess proposed product, process and manufacturing site changes and execute necessary actions for implementation. Support Third Party efforts
Support continuous improvement initiatives by actively participating on local and global cross-functional project teams ensuring milestones are met. May be required to lead small projects (e.g. RFPs, JDE/PEGA. SOPs). Establish and/or improve local processes by reviewing, providing input and/or drafting departmental/cross-functional SOPs and Global procedures
In collaboration with Marketing, Medical Affairs and other business partners review and approve labeling and promotional material for regulatory compliance. Compile materials required for Annual Drug / Device Notifications, Yearly Biologic Product Reviews and Site License Renewals
Participate in driving compliance with the quality system within regulatory affairs in assigned areas of responsibility. Organize and maintain regulatory documentation in a format consistent with current RA practices and Baxter processes. Administrative duties as assigned
Maintain awareness of current regulatory environment and guidelines that impact the Industry, the RA Department and Baxter. Analyze, provide input into and compile comments for proposed regulations, guidance documents and policies. Maintain close communication with both internal and external business partners and build solid advocate network to drive outcomes
University degree in Science and / or relevant work experience
Science Degree (e.g. Pharmacy, Chemistry, Biology, Pharmacology)
Knowledge of Canadian Food and Drugs Act and Regulations and Medical Device Regulations as well as Health Canada policies and guidelines
Ability to interpret and apply Health Canada regulations, policies and guidelines
1 year work experience
Ability to work in a fast-paced dynamic environment
Excellent time management skills and a sense of urgency
Ability to manage multiple projects and deadlines
Strong organization skills and ability to prioritize workload
Accuracy and attention to details
Proficient computer skills including MS Office Applications
Excellent interpersonal and collaboration skills
Ability to work independently and self-motivated to achieve results
Strong critical thinking and problem solving skills
Strong scientific knowledge
Good business acumen
Excellent Word / MS Project and database management skills
Strong Project Management skills
Ability to deal with ambiguity

Senior Regulatory Affairs Associate Resume Examples & Samples

Provides support for US and Canada market product registration activities (e.g., PreMarket Notification [510(k)], PreMarket Approval (PMA), New/Amended Medical Device License Applications)
Works with project teams for New Product Development, Sustaining, and VAVE projects to ensure alignment of business needs and regulatory requirements by providing regulatory input through the lifecycle of the project
Assists global partners with the preparation of regulatory documentation, including completing literature searches to support submissions
Completes review of labeling content, product and process changes, and product documentation
Maintains regulatory files in a format consistent with requirements
Manages facility licensing activities (e.g., Establishment Registrations, Product Listings, Export Certificates (Certificates to Foreign Governments [CFGs])
Develops processes and checklists, and creates procedures to assure early visibility for regulatory requirements related to claims identification and substantiation, labeling, promotional materials, and assuring the validity of clinical, ethical and regulatory compliance issues
Works with Global Regulatory counterparts to assure product compliance internationally
Provides regulatory support for internal and external (Regulatory Agency) audits, and assists with resolving observations
Evaluates and implements procedures pertaining to corporate and departmental regulatory activities
Adaptability
Collaboration and Teamwork
Analytical Skills – Strong analytical skills. Identifies and understands relevant trends, opportunities, needs and market direction within the medical device industry. Proven ability to analyze and interpret data, to provide guidance, data driven decisions and recommendations
Healthcare Industry Knowledge – Understanding of key business issues that exist in the medical device and healthcare industries, i.e. health care economics and trends, state and local laws, regulatory requirements. Link and apply complex technologies to business strategies
Computer Skills – Proficient computer system based tools including Microsoft Office applications, presentation, e-mail, web browsers and spreadsheet software. High computer literacy as it relates to database management and generating electronic submissions
Minimum of 6 years’ regulatory experience in the food, drug, or device industry, preferably related to medical device license/clearance requirements
History of success in making change and achieving objectives required
Successful track record working in a matrix/collaborative environment required
Software system familiarity, including Learning Management Systems, Document Management Systems, Database systems (e.g., ComplianceWire, Documentum, Microsoft Access)

Regulatory Affairs Associate Resume Examples & Samples

Coaches and mentors other associates. Trains less senior associates to review change requests and provides guidance to other associates in the preparation of other FDA submissions
Evaluates changes to regulatory documents and formulates strategies to maintain submission goals
Interacts with FDA and all Teva sites via written and phone communications
Approves IIG ingredients and assures that they are in accordance with the FDA database
Other duties, as assigned, or as business needs require
Timely submissions and expeditious approvals
Assists in developing less senior associates into fully contributing staff
BS in a scientific discipline or equivalent education and related experience
Minimum of three years in a Regulatory Affairs pharmaceutical environment with Analytical, QA, R&D or production experience preferred
Possesses strong critical and logical thinking
Demonstrates thorough knowledge of all FDA requirements pertaining to submission of regulatory documents
Demonstrates excellent organization skills and the ability to multi-task; detail oriented
Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts
Shares concepts, ideas, information, and suggestions with management, peers and others
Demonstrates the ability to evaluate regulatory documents and determine appropriate action
Demonstrates the ability to provide regulatory assessment to other departments with little or no supervision
Demonstrates the ability to coordinate submissions independently in a time intensive situation

Senior Regulatory Affairs Associate / Manager Resume Examples & Samples

Minimum BS degree in scientific or healthcare discipline
Ph.D., or Pharm.D degree preferred
Pharmaceutical / biotechnology industry experience, which shall include 3 years’ experience filing ANDA and 505 (b)(2) applications and obtaining approvals
Knowledge of chemistry, manufacturing and controls, as needed for ANDA submissions
Post approval experience #LI-SA

Senior Regulatory Affairs Associate Resume Examples & Samples

Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures
Responsible for submissions which may include safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations preparing or contributing to preparation of original clinical trial applications and contributing to preparation of marketing authorizations
Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product license for assigned products and territories
Responsible for updating Regulatory databases, systems and archiving
Participate in group meetings and present project status updates and strategic approaches to moderately complex programs/projects
Responsible with manager for development and acquisition of required regulatory skills and knowledge
May initiate or contribute to local process improvements, which have a significant impact on the working of the Regulatory Affairs function or other departments
Responsible for product information activities such as: translations review, implementation and change control of product information, and packaging material review
Past experience on safety information processing is a plus
Extensive relevant industry experience
Degree in a scientific field is preferred
Excellent organization skills and ability to work on a number of projects with tight timelines is required
Excellent verbal and written communication skills and interpersonal skills are required
Very good verbal and written English is required
Must have a reasonable understanding of regulatory requirements
Good knowledge of regulatory systems is preferred
Work is performed under the general supervision of more senior Regulatory Affairs professionals

Temporary Regulatory Affairs Associate Resume Examples & Samples

Collection, review and preparation of documentation in support of regulatory CMC submissions to regulatory agencies in the EU, US and other international agencies
Regulatory support for R&D team for development projects
Regulatory support for third parties for out licencing activities
Create timelines and tracking deliverables to ensure that all submissions are submitted on-time
Review and approve change controls related to proposed products/process changes and their impact on specific regulatory applications
Plan and initiate projects based on consultation with Manager
Update and maintain regulatory information management system as part of on-going responsibilities
Attend relevant functional area and project team meetings as required
Participation in initiatives aimed at improving internal regulatory standards
Maintain departmental cGMP documentation and participate in cGMP project initiatives

Senior Regulatory Affairs Associate Resume Examples & Samples

Provide the regulatory support for brands
Ensure on-going regulatory compliance of product portfolio
Support the resolution of regulatory issues affecting products
Provide regulatory support to internal and external customers in a business oriented way
Work closely with external authorities, partners, contractors and licensees to ensure that regulatory matters are properly managed and issues resolved

Senior Regulatory Affairs Associate Resume Examples & Samples

Medical writing
Controlled substances (e.g. DEA)
Import / export
Regulatory history, guidelines, policies, standards, practices, requirements and precedents
Principles and requirements of applicable product laws
International treaties and regional, national, local and territorial trade requirements, agreements and considerations
Domestic and international regulatory guidelines, policies and regulations
Ethical guidelines of the regulatory profession, clinical research and regulatory process
Communication Skills or Ability to
Communicate effectively verbally and in writing
Communicate with diverse audiences and personnel
Write and edit technical documents
Work with cross-functional teams
Negotiate internally and externally with regulatory agencies
Cognitive Skills or Ability to
Manage projects
Create project plans and timelines
Think analytically
Organize and track complex information
Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Has broad knowledge of various technical alternatives and their potential impact on the business
Exercise good and ethical judgment within policy and regulations
Use in-depth knowledge of business functions and cross group dependencies/ relationships
Define regulatory strategy with supervision
Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues

Regulatory Affairs, Associate Resume Examples & Samples

Serves as an Associate RA representative on project teams
Maintains Regulatory Affairs documentation
Assist in the preparation of division procedures to ensure compliance with Regulatory and Corporate requirements
Performs on special projects as required
No previous regulatory experience is required
Ability to plan and schedule multiple priorities in a concurrent fashion
Complete work with minimal supervision and ability to work independently

Regulatory Affairs Associate Resume Examples & Samples

Provides internal regulatory oversight and support to his/her assigned products as well as direct input in areas of his/her expertise
Functions as the Compliance resource for the assigned products and is expected to be aware of global regulatory agency publications, proposed guidance, inspection reports, and determine trends and areas of compliance emphasis that could affect his/her assigned products. The incumbent is expected to proactively recommend courses of action to implement/improve JM compliance with new regulatory requirements for his/her assigned products
Review and approve the development reports, control procedures, processing procedures, validations, test methodologies, equipment qualifications, and other required documentation which are necessary to both develop a product and also successfully transition it into routine commercial manufacture. The incumbent shall prepare and approve global regulatory submissions and technical packages for customers which describe the manufacturing and control procedures used to manufacture his/her assigned products. The incumbent must be able to successfully defend these documents when questioned during customer audits and regulatory agency inspections
Advises management on the best course of action and preparing responses and correspondence
Functions as a regulatory representative for the Change Control, Deviation, Out of Specifications (OOS), and Trackwise® systems for his/her assigned products
Prepares periodic product review for his/her assigned products
Is knowledgeable of the regulations pertaining to the API industry, including but not limited to ICH Q7, M4 and related guidance, FDA regulations, etc
Provides technical knowledge to all departments when developing regulatory policies and procedures
Ensures site regulatory policies and procedures are compliant with state and federal requirements, including but not limited to GMP, DEA, FDA, etc
Reviews all investigations and documentation to ensure compliance with Johnson Matthey’s Standard Operating Procedures (SOPs), all state and federal regulations
Provides guidance to all departments on regulatory-related issues
Is knowledgeable in the understanding of all EH&S policies and procedures
Ensures that all job activities comply with any EH&S related rules and regulations that pertain to the department
Support the Company’s commitment for environmental health & safety by applying ISO 14001 and Sustainability 2017 principals into daily activities

Regulatory Affairs Associate Resume Examples & Samples

Preparing ANDAs and amendments for FDA submission
Evaluating change controls and provide regulatory assessment
Performing labeling review
Performing special projects assigned by Regulatory Affairs management

Regulatory Affairs Associate Resume Examples & Samples

Preparation and submission of CTD dossier style packages to customers and eCTD dossiers direct to TGA for OTC and Registered Complimentary applications
Preparing and maintaining regulatory documentation to support Catalent and customer products \licences
Providing Regulatory advice and support to internal and external customers from development through full life cycle management
Accurately, listing (AUSTL)/registering (AUSTR) products in eBS and maintaining records on the ARTG as required
Applying for, obtaining and keeping current licences and permits at all times
Preparing and maintaining GMP Agreements and Product Quality Reviews, with all Catalent customers (as an approved delegate of the Regulatory Affairs Manager)
Managing key Quality & Regulatory projects as identified
Providing advice, guidance and education to others on regulatory matters
Degree in Pharmacy or Science or equivalent
Experience working in a GMP environment
Proven experience in Pharmaceuticals with accountability for compliance and/or regulatory affairs
Demonstrated experience working with CTD format information (experience in writing bioequivalence justifications/biowaivers would be an advantage)
Demonstrated competency using actual or like IT systems such as; eCTD Manager, Manage, ComplianceWire and TrackWise, or equivalent systems
Demonstrated competency using MS Office Computer skills - spreadsheets (Microsoft Excel), scheduling (Project) word processing, graphics (PowerPoint) and email (Outlook)
Demonstrated ability to work productively with others, utilising a consultative/participative approach
Demonstrated ability to generate rapid, positive change within an organisation. In particular, the ability to generate change through a collaborative and participative team approach
Project management experience would be highly regarded
Ability to network effectively at all levels, and represent the company in a professional manner at all times, both on and off site
Demonstrated Continuous Improvement experience
Demonstrated ability to build effective relationships
Demonstrated ability for effective oral and written communication skills

Regulatory Affairs Associate Support Resume Examples & Samples

First point of contact for Country Operations Regulatory Affairs (CORA) arranging and providing all necessary documentation required in support of obtaining and maintaining product registrations, in line with the licensing strategy
Executing all regulatory procedures in the EU (new licensing/maintenance)
Expert in country/regional regulatory requirements and
Keeping oversight of all regulatory activity in countries worldwide
Submission strategy for new products in alignment with other GRA teams
Organize and manage all typical administrative tasks for the GRA teams in Boxmeer like meeting organization, travel arrangements, travel cost management etc
Manage purchase orders in SAP-SRM and ensure archiving where necessary
Extract data from the regulatory databases, organize data and provide overviews as required. Format presentations
Actively exchange with our CORA regulatory information as well as provision- and tracking and tracing of data and documents
Maintain and quality control of archiving systems
Will be part of the GRA Support Team consisting of two other colleagues dividing the workload
MBO+ work and thinking
Minimum 3 years’ experience in a similar function
Committed, accurate, service-minded, pro-active attitude and easy approachable
Solid experience with Office software and the ability to learn new systems
Communication in Dutch and English
Capable of discreetly handling confidential information
0,8 FTE Minimum

Regulatory Affairs Associate Resume Examples & Samples

BS/BA degree in an engineering or scientific discipline with 0-2 years of experience in International regulatory affairs/compliance, preferably in Latin America. Experience in product complaint handling, documentation and reporting is strongly preferred
Basic knowledge of FDA, ISO, EU regulations pertaining to medical devices
Strong regulatory compliance documentation skills. Experience in preparing regulatory submissions and associated documents legalization is preferred
Ability to handle multiple tasks and to prioritize and schedule work to meet business needs
General computer knowledge and working ability with MS office programs is required
Collaborate and execute regulatory strategies for global registrations and compliance with particurlar emphasis on international Markets
Work with local regulatory agents and distributors to assist in the preparation, compilation and maintenance of regulatory registrations in international markets
Obtain CFGs and co-ordinate document legalization to support international regulatory submissions
Complete change control documentation for regulatory related product and label changes
Have a basic understanding of pertinent ISO/FDA/EU/EPA regulations, standards and guidance documents that dictate compliance requirements for all Cantel products
Participate on project teams to provide regulatory input as assigned. Assist in the determination and definition of regulatory requirements for project teams and stakeholders throughout the organization

Post-market Regulatory Affairs Associate Resume Examples & Samples

BS degree in scientific, engineering or technical discipline with 0-2 years of experience in regulatory affairs, preferably in medical devices, or equivalent
Basic knowledge of U.S. regulations in the areas of the FDA and international regulations such as ISO 13485 and post-market surveillance and medical device vigilance is preferred
Demonstrate independent problem solving skills and solid written/verbal communication skills. Strong attention to detail
Experience in U.S. and international regulatory complaint handling and reporting is preferred
Completion of downstream regulatory compliance tasks to help achieve RA departmental objectives
Successfully assist and execute regulatory vigilance reporting, medical device reporting, complaint handling and product recall activities
Conduct complaint investigations with customers, field assurance team members for regulatory related documentation on product vigilance reports and complaints
Complete domestic and international downstream regulatory affairs and post-market activities for company product lines. Update and maintain essential requirements checklists and technical files for products sold in the EU market
Review and determine regulatory implications and requirements of product, labeling and/or other change control documentation or design changes
Participate on project teams to provide regulatory input as assigned. Prepare post-market regulatory strategies, plans, documentation and submissions for the products assigned
Support continuous improvement initiatives for downstream regulatory compliance processes
Assist in the development and maintenance of Safety Data Sheets required for Cantel Medical products in accordance with the latest regulations
Provide Regulatory support in the pre and post entry review of import and export compliance

Senior Regulatory Affairs Associate Resume Examples & Samples

Represent Regulatory Affairs on internal and external cross-functional teams, providing regulatory affairs support and strategy for investigational and/or marketed products for HIV, as assigned
Prepare IND and NDA submissions for assigned products, which may include routine submissions (e.g., safety reports, DSURs, PSURs/PBRERs, and NDA Annual Reports) as well as IND amendments and NDA supplements, as needed
Potential opportunity to support compilation and submission of new INDs and/or NDAs
Work within the department and with other functional areas on process improvements
Prepare regulatory submissions for assigned IND or NDA products, including routine submissions (e.g., PSUR/PBRERs, NDA Annual Reports, DSURs, etc.) as well as IND amendments and NDA supplements, as needed
Contribute to preparation and filing of original IND and/or NDA submissions, as required
Engage cross-functional teams (internal and/or external teams) to develop submission strategies for US submissions (as required) in line with ICH/regional requirements and company policies and procedures
Support development and/or revision of product labeling (e.g., USPI, CCDS/CSI) in accordance with ICH/regional requirements and in alignment with company policies and standards, as needed
Participate in team meetings (e.g., study management teams and regulatory submission/project teams) for assigned products, including development of regulatory strategy and presentation of ongoing project updates
Under guidance of immediate manager, oversee self-development and acquisition of required regulatory skills and knowledge
Initiate and/or contribute to local process improvements which have an impact on the Regulatory Affairs function and/or other departments
As necessary, liaise with FDA for assigned projects/products
Minimum of a BA/BS degree (an advanced degree is desirable)
Minimum 5 years of experience in Regulatory Affairs or related field
Excellent organizational, interpersonal, and communication skills
Ability to work independently on multiple projects with tight timelines and minimal supervision
General understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories

Regulatory Affairs Associate Director Resume Examples & Samples

Provide commercial regulatory knowledge, consultation, advice and risk assessments to the US organization, including senior leadership, that are aligned with corporate commercialization efforts
Collaborate with SSF cross functional teams, Field Sales team, as well as global teams in creating and reviewing promotional materials to ensure compliance with related corporate and regulatory requirements while meeting strategic promotional objectives
Work with cross functional teams to enhance systems, technology and processes
Represent Regulatory Affairs as a member and Chair of the Actelion Review Committee (ARC)
Provides guidance to members of the ARC regarding the current regulatory environment and regulatory considerations that may impact business activities
Provide regulatory oversight and advice regarding advertisement and promotion materials (e.g. marketing materials, education materials, institutional promotion, disease education, press releases, websites, speaker presentations)
Provide regulatory guidance to the Medical Review Committee (MRC)
Develop and refine consistent regulatory strategies for advertising and promotional of multiple marketed products; ensuring that labeling, promotion, and advertising materials conform to regulations, guidances and the lawEnsure Actelion’s regulatory processes are compliant with federal regulations pertaining to Subpart H, 2253, regulatory and risk management requirements
Provide direction and supervision to assure quality and timely submission (including electronic submission) of advertising and promotional materials to FDA in accordance with business objectives
Coordinate and lead communication with the relevant personnel at the FDA/OPDP to ensure successful interactions with the agency build a rapport and track evolving regulatory developments that impact the conduct of our business and inform senior management as appropriate
Identify potential areas of regulatory compliance vulnerability and risk; develops/implements corrective action plans for resolution of problematic issues, and provide general guidance on how to avoid or deal with similar situations in the future
Ensure quality documents are defined, created, maintained and implemented globally in accordance with Actelion requirements. In addition, provide local input on global SOPs as appropriate
Coordinate corporate wide on-going regulatory training to SSF office, field colleagues, medical congress booth staff, as well as speakers and vendors on regulatory issues pertaining to promotion of Actelion products
Regularly monitor the regulatory compliance trends in the industry, interpret new regulations, guidance documents and enforcement activities, and evaluate the impact on the industry and the company
Work with Regulatory Management Team in development of Commercial
Regulatory strategies, policies, cross-functional projects, and interdepartmental decision-making
Act as liaison for temporary/contract workers
Bachelor's degree with at least 8 years biopharmaceutical industry experience, including at least 6 years in Regulatory Affairs; equivalent combination of advanced degree and less experience will be considered

Regulatory Affairs Associate Resume Examples & Samples

Reviews and prepares routine (e.g., investigator submissions, correspondence to FDA, etc.) regulatory submissions as well as supports senior-level staff in the preparation, QC, and submissions of major submissions (initial INDs, NDAs, sNDAs) for investigational and/or marketed drug products
Works with Supervisor to develop regulatory strategy on preclinical, clinical and/or CMC issues
Regulatory Intelligence (research regulations, guidance, precedence )responsibilities as assigned by Supervisor
Coordinates and supports the team in planning and preparation for FDA meetings or teleconference
Follows Teva Safety, Health, and Environmental policies and procedures
Other duties as assigned or as business needs require (e.g., support submissions for Health Authorities beyond FDA)
Bachelor’s Degree in scientific field or equivalent combination of education and related work experience- required
PharmD, or Master’s degree preferred
2 years of pharmaceutical industry experience in new drug regulated product strategy and submissions; including working knowledge of FDA regulations and guidance for new drugs
Evolving understanding of regulations/guidelines governing development of pharmaceuticals preferred
RAPS RAC (U.S. or EU) certification beneficial, but not required
Demonstrates an understanding of ICH and FDA guidelines as well as FDA regulations (21 CFR) and GXPs

Regulatory Affairs Associate Resume Examples & Samples

Validate product composition and labeling compliance under US laws & regulations
Manage state licensing requirements for bottled water operations
Coordinate product and plant testing requirements for purposes of regulatory compliance
Participate in validation of new marketing campaigns
Validate new marketing materials and approve artwork/labels/graphics/claims
Develop product labeling master files (nutritional masters) for dairy products
Maintain and/or update current ingredient data and claim attributes in internal databases for dairy products
Contribute Regulatory perspective in brand and cross-functional meetings
Support the review and validation of product and packaging innovations
Develop and support internal and/or external education of the water category and the benefits associated with healthy hydration
Anticipate and help the business and NORAM teams prepare for changes in regulations
Support plants with US regulatory compliance questions
Train internal stakeholders on specific regulatory matters relevant to the business
Work with Public Affairs in supporting category defense and growth activities through trade associations
Work with suppliers to develop product specification information as it relates to regulatory claims for dairy products
Support the management of crises as needed
Knowledge of and experience with United States food regulations. Knowledge of bottled water regulation is preferred; knowledge of dairy regulation is a plus
Strong writing and presentation skills required
Fluency in French is a plus
Strategic thinker adept at working cross-functionally to achieve goals in a timely manner
Doer - Be creative, bring new or alternative solutions for business within the regulatory framework
Committed - seeks out needed resources to get job done
Open - Talk with honesty and without fear
Minimum of 4 years of experience in nutrition and regulatory affairs
Food science, biological science and/or nutrition background is a plus

Regulatory Affairs Associate / Project Leader Resume Examples & Samples

B.Sc. minimum in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
3-5 years experience in drug regulatory affairs, including clinical and labeling submissions
Good working knowledge of the Canadian Food and Drugs Regulations, relevant policies and guidelines
Good understanding of the drug development and commercialization process
Ability to react quickly and provide creative solutions to problems
Able to manage multiple projects and tight timelines
Competence with the electronic business environment
Ability to work with diverse groups of individuals in a team
Provides input into the planning and supports preparation of regulatory submission (NDSs, SNDSs, CTAs, NCs, etc) to aggressive targets
Ensures regulatory compliance with HPFB requirements and alignment with business needs
Provides input into the development of submission strategies and works with others to negotiate with HPFB towards rapid approval with optimum labeling
Liaises with multiple local and global functional groups to ensure Canadian regulatory needs are met
Identifies and responds to issues related to assigned projects
Interprets Canadian regulations, guidelines and policies as they apply to GSK commercial activities

Regulatory Affairs Associate Resume Examples & Samples

Experience with at least one of; medicinal, cosmetic, medical device and food product regulations as required by the Category supported or significant adjacent experience in NPD, Quality, Medical, Toxicology within a Consumer Healthcare environment
Experience of working on similar or related products
Awareness of regulatory processes in at least one geography
Masters Degree or PharmD
1+ years relevant experience
Acts as a Business Partner and provides regulatory advice to a project on aspects of drug/cosmetic/devices/foods and supplements development as appropriate
Develops regulatory strategies under supervision working within Project Teams in order to secure competitive approvals and speed to market in conjunction with LOC regulatory teams
Communicates effectively with the immediate functional team and within cross-functional Project Teams
Delivery of high quality core files to agreed timelines
Inputs to non-product related activities both within the function in order to direct new policy or pioneer new processes or improvements to GSK's competitive advantage
Support the full life cycle of products under supervision, including: maintenance activities; Design to Value, complexity reduction, engineering initiatives; change controls, Core File updates
Ensures compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions

Regulatory Affairs Associate Resume Examples & Samples

Bachelors degree, preferably Pharmacy, Chemistry or Biology
3 plus years of relevant experience
Masters degree or higher
OTC drug, Monograph and/or dietary supplement Regulatory experience in US
Partners with the business to deliver regulatory outcomes
Performs with independent judgment and execution in a defined area which directly impacts the operational results of the business unit
May manage or mentor team members and provide day to day support and guidance

Senior Regulatory Affairs Associate Resume Examples & Samples

The preparation, submission and tracking of accurate and timely regulatory applications with a focus on the respiratory therapeutic area
Assisting with the development and implementation of global GSK regulatory strategy
The maintenance of registered products ensuring product compliance
Working closely with local brand teams and global groups to proactively manage and where appropriate create, the response to all regulatory questions received from the Australian Regulatory Authorities (TGA) and Medsafe (NZ) within an agreed priority and timeframe
To provide input and expertise to assist commercial, technical and marketing teams with new product initiatives and activities
A degree in pharmacy, chemistry or pharmacology with a strong preference for post graduate studies
First-hand experience with major submissions in Australia essential (NZ experience desirable)
Experience and subject matter expertise in regulatory affairs within the pharmaceutical industry specifically in the area of prescription medicines
Exceptional written and verbal communication skills with the ability to foster positive and proactive relationships with a broad range of stakeholders including the TGA, Industry Associations and a broad range of internal stakeholders
Strong analytical skills, excellent attention to detail and a commitment for compliance processes
Ability to think strategically and innovatively for resolution of regulatory issues

Regulatory Affairs Associate Resume Examples & Samples

Provides input into multiple Regulatory projects inclusive of EMA Policy 0070 clinical data redaction engagements
Authors, compiles and or reviews various Regulatory documents
Authors or reviews Accenture RA SOPs, internal guidance documents and training materials
Liaises with internal and external teams to meet project deliverables
Coordinates project timelines and workflows
Supports Regulatory Operations in the generation and assembly of all types of Global electronic submission filings including eCTD and NeeS
Maintains and updates metrics in appropriate databases
Archives all client data and documents in appropriate databases per appropriate Accenture or client SOPs
Assure standards adhere to Accenture and/or client SOPs and guidance
Bachelor’s degree in natural science, life sciences or pharmacy; advanced degree is preferred
Up to 2 years’ experience in pharmaceutical regulatory affairs. Additional relevant experience in a Life Sciences industry may be preferred
Knowledge in handling registrations and maintenance of pharmaceutical, medical device, consumer and/or cosmetic products from a global, regional and local perspective
Excellent international regulatory understanding and experience in handling business process excellence
Establishes excellent working relationships with peers and team members through integrity, credibility, reliability and trust
Establishes confidence in one’s regulatory abilities and develops long-term trusting relationships
Promotes the professional growth of self to achieve individual and organizational goals
Analytical/strategic skills
Ability to work on numerous projects and under pressure

Regulatory Affairs Associate Resume Examples & Samples

Support the compilation, development, and submission to FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws such as IND amendments, NDA supplements, annual reports
Create timelines and tracking deliverables to ensure that all submissions are done on-time
Represent Regulatory Affairs on internal and external cross-functional teams, providing regulatory support and strategy for investigational and/or marketed products, as assigned
Coordinate required documentation with CMC and other cross-functional teams to support global clinical trial application submissions, as assigned
Analyze new regulations and guidelines and make process improvement recommendations to the regulatory affairs group as assigned by supervisor
Prepare and deliver effective presentations for department meetings
Pays close attention to detail, strong organizational skills, and ability to prioritize multiple projects
Displays good interpersonal skills and ability to deal effectively with a variety of personnel
Demonstrates advanced knowledge and understanding of applicable regulations

Regional Regulatory Affairs Associate Resume Examples & Samples

Submit products files to MOH either for new registration or renewal and ensure that filing & submission meet local requirements & company objectives
Coordinate the preparation, review, submission and follow-up of regulatory files that are properly formatted and in compliance with local regulations
Be involved in all aspects of the application to take the product to market
Execute regulatory plans and manage timelines to achieve the stated goals
Ensure that relevant local regulations are properly communicated to the different stakeholders internally & externally
Respond to inquiries from the different HAs
Maintain archiving of correspondences and other records of all filings and interactions with regulatory authorities
Update regulatory databases, tracking tables & information systems
Develop & maintain relationships with Health Authorities & other relevant organizations
Maintain current knowledge of existing as well as emerging regulations, standards and guidance documents
Provide regulatory support to all company functions upon request
Comply with local laws & HCC guidelines, Foreign Corrupt Practices Act (FCPA), Policy on Business Conduct (PBC)
Ensure that all regulatory activities are conducted in compliance with relevant laws & regulations as well as J&J guidelines
Bachelor’s Degree from Medical related field
Past experience in RA field
Comprehensive knowledge of regulatory requirements, MOH regulations & guidelines
Strong knowledge base and skill set in science
Confident communication and presentation skills, both verbal and written
Demonstrated ability to manage multiple assignments
Strong interpersonal skills to deal with sensitive and occasionally contentious issues

Regulatory Affairs Associate Resume Examples & Samples

Bachelor’s Degree in a related, Communications or Scientific Discipline; or an equivalent combination of education and related experience
3+ years experience in regulatory, quality assurance, quality control, or similar in a regulated environment
1+ years experience in graphic arts or product labeling, or an equivalent combination of education and related experience, if applicable
Foreign language skills a plus

Regulatory Affairs Associate Resume Examples & Samples

Provides regulatory support and guidance to assigned device product teams
Determines regulatory pathway and provides complete global regulatory assessment of product changes, including submission of 510k packages, as appropriate
Provides regulatory support for international registrations and requests for documentation, and support for registration of portfolio products in new markets
Review and approval of product labeling and advertising
Minimum of three (3) years of medical device experience working in a regulatory, laboratory and/or quality function
Bachelor’s degree or higher Biomedical Engineering, Mechanical Engineering, Chemical Engineering or related discipline from an accredited institution
Basic understanding of FDA device regulations
Experience working with medical device hardware and/or software
Ability to work effectively in cross functional teams

Regulatory Affairs Associate Resume Examples & Samples

Work in close collaboration with the Associate Director, Regulatory Affairs and key stakeholders in the filing of quality submissions, effective problem solving and negotiations with Health Canada officials
Manage and lead approval of assigned new products and claims; manage changes to existing products which includes cosmetics, OTC drugs and Natural Health Products
Determine and communicate submission and compliance requirements to key stakeholders within the company and gather and compile necessary data
Monitor and influence Regulatory and External Environment; anticipate and proactively affect changes to the Canadian Food and Drug Act and Regulations, Policies/Guidelines, Cosmetic Regulations, Natural Health Product Regulations
Collaborate with and support JJI business partners to ensure that product claims and advertising are compliant, competitive and contribute to optimal marketing of products
Manage competitive complaints from and to regulatory authorities and competitors, in collaboration with legal and marketing
Maintain vigilant oversight of developments within the assigned therapeutic and/or functional area, communicating key competitive learnings to Marketing and Regulatory Affairs colleagues as appropriate
Keep abreast of all product changes and other issues relating to the sale and distribution of marketed products through Change Control processes and regular communication with colleagues (i.e. Marketing, Medical Affairs, R&D, QA/QC, Global Regulatory). Ensuring all the marketed products retain positive registration status in the changing regulatory environment and are in compliance with Canadian Food and Drug Act and Regulations and other applicable legislation (e.g. Environmental Regulations)
University degree in a scientific field (Life Sciences, Chemistry or, Pharmacy)
Approximately 2-3 years of progressive experience in Pharmaceutical Regulatory Affairs
Demonstrated experience in obtaining approval of a variety of submissions and in-depth knowledge of the Canadian Food & Drugs Act and Regulations., Natural Health Product Regulations, Cosmetic Regulations and HC guidelines and policies
Canadian non-prescription drug, Natural Health Products and cosmetic experience an asset

Senior Regulatory Affairs Associate Resume Examples & Samples

Sound basis of Regulatory and Scientific knowledge
Knowledge of regulations
Technical system skills (e.g. electronic document management, spreadsheets, databases, online research)
Manage multiple projects and deadlines
Bachelor’s degree or country equivalent in pharmacy or related scientific discipline with a minimum of 2 years regulatory or equivalent experience within a pharmaceutical company, CRO, or similar organization. Higher degree/PhD will be an advantage

Regulatory Affairs Associate Resume Examples & Samples

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 expectations - support key processes and ways of working (eg, in relation to GSK CMC, quality, product labelling 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 company stakeholders as required to build knowledge and compliant utilisation
Maintain high level of knowledge on the science of products within defined portfolio

Regulatory Affairs Associate Resume Examples & Samples

You have a passion for achievement; be entrepreneurial, self motivating and the integrity and drive with a strong desire to make things happen
You want to have accountability for leading and coordinating the resolution of regulatory issues and provide advice to the company on registration and compliance issues
You want to effectively communicate and collaborate with other functions within RB to ensure that the business remains compliant
Work on a range of RB Products such as Dettol, Finish, Vanish, Calgon, Woolite, Cillit Bang, Harpic, Air Wick, Veet, Clearasil, Scholl and E45 sold in the UK and Ireland
Work collaboratively with the relevant country teams to establish and implement the regulatory strategies within agreed timescales to bring competitive advantage to RB brands
Interpret and apply all relevant legislation in the UK to keep the RB business up to date on national regulatory trends, risks and opportunities
Responsible for the regulatory approval of promotional material
Provide regulatory support and advice to other functions to ensure products are maintained in compliance with the local requirements
Ensure compliance to all regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of our products
To maintain the internal processes (such as issuing documents, updating databases)
To work with external agencies to correctly notify and register products in a timely fashion
Science degree in relevant scientific discipline and regulatory and product safety experience
Understanding of the current regulations, laws and industry requirements
Ability to manage workload and identify priority tasks to meet tight deadlines
Strong influencing / communication expertise
Ability to build good relationships and challenge constructively and confidently
Ability to consolidate large volumes of complex information, interpret & construct straightforward plans. Naturally inquisitive and interested in our brands
Confident and capable of operating at all levels and able to resolve conflict situations
Competent with PC tools and information systems
Ability to challenge the status quo and propose improvement
Able to apply appropriate problem solving techniques to evaluate and resolve operational issues
Experience in Household and/or Cosmetic goods

Regulatory Affairs Associate Resume Examples & Samples

Position will support new product development cross-functional project teams acting as the regulatory affairs team member including the development and execution of the regulatory strategy for both US and EU markets
Liase with cross-functional team to drive regulatory deliverables such as 510(k) submissions and EU Technical Files and/or Design Dossiers
Facilitate international registrations, assist with change control activities, and revise departmental procedures

Regulatory Affairs Associate Resume Examples & Samples

Work collaboratively with other functions and provide the regulatory support to enable delivery of ANZ business brand plans, Squeeze and Global Ingredient Removal projects
Ensure the regulatory compliance of ANZ products to bring competitive advantage to our brands
Amend registration dossiers as necessary for country-specific regulatory requirements, submit registration applications and negotiate with governmental authorities to obtain rapid approvals with favourable labelling and claims
Provide regulatory and product compliance expertise in the area of advertising and label claims for existing and new products
Assist with local statutory reporting requirements
Monitor and interpret local regulatory issues and trends that will impact the marketability of company products and ensure that the company is aware of significant regulatory issues
Interface with local government agencies and industry associations to assess the impact and implementation of required company compliance with all legislation and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of our products
Prepare, maintain and update local product registration and regulatory compliance files and databases

Regulatory Affairs Associate Resume Examples & Samples

Artwork
Data administration
Label Coordination
Committed to caring
Responsible to our communities
Unique in our background and experiences
Passionate about doing what’s right

Regulatory Affairs Associate Resume Examples & Samples

*Please note, this is a 1 year contract***
Degree in a pharmaceutical or life science / science
Direct experience working within regulatory affairs for NHP, OTC, DIN, medicinal products and/or devices or cosmetics, a minimum of 1-2 years
Awareness of regulatory processes in Canada
Experience of working flexibly across a portfolio of products
Knowledge of eCTD and related electronic submission processes
Demonstrated ability to review and approve regulatory documentation
Scientific background is required to enable an individual to work under the direct supervision of expert/manager with guidance (minimal autonomy)

Regulatory Affairs Associate Resume Examples & Samples

FDA, SOP and cGMP standards, guidelines and regulatory compliance regulations
Pertinent Federal and State laws related to pharmaceutical regulatory affairs
Supervision and training practices and methods
Business, scientific and personal computer software applications
Business English usage such as, spelling, grammar and punctuation
Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods
Company policies, practices and procedures, including safety rules and regulations
Principles and practices of budget preparation and administration

Regulatory Affairs Associate Resume Examples & Samples

Execute global regulatory labeling strategies and plans for multiple complex projects including new products and ongoing compliance for products already on market. Understand and incorporate key labeling requirements and best practices into global labeling strategies
Help drive global UDI initiatives as well as global labeling traceability requirements within project and product teams
Represent the RA labeling function on assigned cross-functional project teams and projects. Contribute independent ideas and help guide the overall effectiveness of the cross-functional labeling team
Monitor applicable global regulatory and labeling requirements; assure compliance with Baxter and external standards and help drive implementation across functions and projects
Help assess impact of emerging global labeling regulations and requirements and help implement appropriate changes. Support development of company policy and positions on draft regulation and guidance
Effectively perform gap analysis across multiple products and projects- including high volume tasks requiring global consistency. Support and document sound regulatory decisions and justifications
Establish appropriate cross-functional partnerships within RA and other functions to drive key global labeling strategies and initiatives
Ensure project teams and business objectives and deliverables are aligned with regulatory strategy
Demonstrated interpersonal skills including strong negotiation and facilitation skills

Regulatory Affairs Associate Resume Examples & Samples

Applications for approval of new pharmaceuticals to Norwegian Medicines Agencies (NOMA) as well as submissions to NOMA for approval of changes or renewals of products on the market
Updates of prescribing information to physicians and information to patients
Align labelling materials to harmonize with authority approvals
Review and approval of our promotion material
Being an active partner in cross-functional teams

Regulatory Affairs Associate Resume Examples & Samples

Represents Regulatory Affairs on cross-functional project teams to support planning, development, implementation and execution of marketing strategies and ensures alignment with project business goals relating to combination product chemistry, manufacturing and controls (CMC) as well as product labeling issues on a local and global basis
Collect documentation for Annual Product Reviews
Degree in Pharmacy, Live Science, Chemistry or Medicine
Experience working in Regulatory Affairs function in Healthcare, Pharmaceutical
Clear understanding of HC regulations in Russia, basic knowledge about CIS is a plus
Result-oriented, though paying appropriate attention to the details, without derogating the ability to see the bigger picture
Good time management and self-discipline, sharp adherence to the deadlines
Ability to communicate scientific information. Strong interpersonal and communication skills
Fluent English language skills

Senior Regulatory Affairs Associate Resume Examples & Samples

Plans, coordinates and writes responses to inquiries from the FDA resulting from their review of the submissions. Submissions will include: ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) files
Reviews technical documents for accuracy and acceptability
Independently authors, complies and reviews ANDAs, NDAs, Amendments, Supplements and Annual Reports
Reviews and signs-off on change control documentation
Translates and communicates regulatory requirements and strategies to team members and to internal/external business units

Regulatory Affairs Associate Resume Examples & Samples

Develop and maintain GTS training and procedures
Conduct training for in- country and BU RA teams on GTS as needed
Maintain and ensure data integrity and completeness in GTS
Develop and conduct periodic audit plans to ensure quality data
Coordinate with regional and in-country RA teams to identify training needs
Identify training needs, and optimize business process
Follows Zimmer Biomet RA policies and procedures
Miscellaneous responsibilities as assigned
Strong writing, communication, and interpersonal skills
Ability to work with rapid changes; flexible and able to balance competing priorities
Ability to learn and apply regulations pertinent to medical devices, biologics, drugs and combination products, specific to functional work team
Self-motivated and capable to work in a diverse, fast-paced and dynamic environment
Ability to build strong relationships; communicate effectively at all levels
Basic computer skills, including Microsoft Office Suite
Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field preferred
Limited regulatory submission preparation experience a plus

Senior Regulatory Affairs Associate Resume Examples & Samples

Degree level education in a life science subject
Detailed knowledge of the regulations and guidance for global markets including, but not limited to, EU, FDA, Canada, Australia, Japan, and other distributed markets
Understanding of Quality Management Systems - FDA QSR, ISO 13485
Detail oriented and excellent written and verbal communication skills
Experience with medical device systems
Minimum 4 year experience in medical device regulatory affairs

Regulatory Affairs Associate Resume Examples & Samples

Provide regulatory affairs post-market support for company devices as well as assist with new product submissions
Preparation, maintenance and provision of Material and Device Master Files
Assist with Regulatory documentation preparation, compilation, submission and filing as required with applicable Regulatory bodies (both domestic and international) for product registrations
Respond to requests for Regulatory supporting documentation (i.e, CFG’s, ISO certificates, etc.)
Submit annual site registrations (i.e., FDA Establishment Registration/Device Listing(s), Health Canada MDL updates, etc.)
Ensures appropriate maintenance of regulatory documentation
Assists the Regulatory Affairs team with the creation, modification/update, and/or implementation of Regulatory Affairs policies, programs, and procedures as necessary
Other tasks and projects as assigned

Project Manager Regulatory Affairs Associate Director Resume Examples & Samples

May act as a Project Manager for a large stand-alone program, involving several regulatory or technical deliverables and/or region, and/or operation. Undertakes risk analysis, management and contingency plans, as appropriate
Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate
May manage meetings with Regulatory Agencies
May write and/or review a complete single service regulatory proposal and defend costs and timelines to clients
Provides mentorship to junior colleagues and advise others on many regulatory document types
May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications
May be assigned as Reviewer and/or Approver for Regulatory SOPs or cross-functional SOPs owned by other operations
May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative
Performs other tasks or assignments, as delegated by Regulatory management
Extensive experience in regulatory and/or technical writing
Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers
Acts as a role model to junior colleagues; possesses a positive attitude and communication style to customers and colleagues. Communicates effectively with all levels of the organization and remains motivated and enthusiastic in times of change and other pressure situations
Ability to exercise independent judgement taking calculated risks when making decisions

Regulatory Affairs Associate Resume Examples & Samples

AS or BS degree, preferably in a scientific or legal discipline
Prior professional work experience in a regulated product industry or legal or governmental office; relevant internship experience will be considered
Excellent oral, written, and organizational skills required
Attention to detail is particularly important
Must be able to work as part of a team in a collaborative and constructive manner
Strong computer skills required; must be proficient in MS Office applications. Knowledge of SAP preferred
Ability to multi-task and prioritize multiple projects and work effectively with regulators, customers and co-workers
Ability to work in a constant state of alertness and safe manner

Regulatory Affairs Associate Resume Examples & Samples

Review of formulation (ingredients, nutrient levels) and other technical data associated with new product formulations to ensure in line with current legislation
Provide advice on suitability of formulations for Israel market
Representation of Regulatory Affairs in cross functional New Process Introduction Teams
Develop new (and maintain existing) product labels and datasheets in line with current legislation
Liaison with manufacturing sites, corporate head-office and affiliate departments on regulatory issues
Liaison with external regulatory authorities as required
Review new legislation and identify implications for Abbott Nutrition products
Provide technical support to Commercial Division as necessary
Ensure compliance with statutory obligations in respect of the above

Senior Regulatory Affairs Associate Resume Examples & Samples

Degree holder preferably in Science or Medical related field
At least 3 years regulatory affairs experience in pharmaceutical industry is preferred
Relevant work experience in medical device companies will also be considered
Excellent in communication and interpersonal skill
Well-organized, detail-minded and diligent
Proactive and able to work independently
Position may be offered to less experienced as Regulatory Affairs Associate

Regulatory Affairs Associate Resume Examples & Samples

Evaluate customer packaging documentation (non-Type B) for adequacy tocover QSA Global, Inc. shipments using that packaging
Generate package specification sheets for use by the staff to supportloading, handling and shipment of radioactive material packages from QSAGlobal, Inc. sites
Assist in the investigation of radioactive material products (orassociated equipment) return evaluations and recommend corrective actions
Assist in the preparation of regulatory submissions to gain productapproval
Provide technical customer assistance
Prepare and maintain regulatory submissions to domestic andinternational regulatory authorities to gain necessary approvals/certificationsto allow for distribution of QSA Global, Inc. radioactive products, includingprimarily
Type A evaluations
Type B approvals
Special Form approvals
Export License approvals
Ensure product line and subsequentregistrations/approvals and submissions are up to current standards andaccurately reflect product manufacturing
Participate in product testing toensure regulatory compliance
Bachelor’s degree in Radiologic Science, Engineering or equivalent training
Minimum of 3 months experience in the Regulatory field
Working knowledge of standard computer software, i.e.spreadsheets, databases and word processing
Fast learner who picks up on and retains new information
Ability to manage time effectively and set priorities
Demonstrates approachability, listens well to others andis a team player
Excellent communication skills, both written and verbaland the ability to communicate to all levels
Ability to use logic and reasoning to identify the strengths andweaknesses of alternative solutions, conclusions or approaches to problems

Regulatory Affairs Associate Resume Examples & Samples

Under close supervision, utilizes established policies and procedures to support regulatory submission (drugs and device) and publishing activities
Assists in the maintenance of an archiving/document management system
Produces and tracks FMCNA regulatory submissions and submissions-compliant documents in the electronic format (eCTD and eFiling)
Assists in implementing and maintaining various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory information system, and electronic submissions
Works with department and external groups as assigned
Participates in new department technologies evaluation and provides input. Collaborates with intra-departmental resources to ensure adherence to infrastructure standards
Compiles, publishes, QC, and validates documents for FDA submission
Troubleshoots document issues in MS Word and Adobe Acrobat
Provides editing and formatting support
Supports the transition from legacy to electronic submissions
Coordinates with regulatory staff to compile regulatory submissions
Ensures all required documents are received and formatted appropriately and in a timely manner
Demonstrates knowledge of electronic submission requirements and prepares for future initiatives and requirements
Aligns document access and storage with RA electronic submission needs through a document management system
Assists in development of overall project timing
Builds stable working relationships internally
May refer to senior staff, if applicable, for assistance with day-to-day problems that may arise
Escalates issues to supervisor/manager for resolution, as deemed necessary
Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations
Assist with various projects as assigned by direct supervisor
0 – 2 years’ related experience
Experience with Document Management a plus
Understanding of document management processes in a regulated pharmaceutical/device environment
Demonstrated ability to work to manage projects as part of a team
Must be highly proficient in MS Office (emphasis on MS Word), Adobe Acrobat (version 5.0 or higher)
Knowledge of EDM, RIM and electronic publishing software preferred. Experience with electronic submissions, specifically eCTD, or eCopy a plus
Outstanding interpersonal and communication (written and verbal) skills
Detail oriented, proactive, effective task planning and coordination of activities
Strong software troubleshooting skills highly desirable
Experience with Adobe, desktop publishing software, document management solutions, database software and Microsoft Office
Detail oriented; ability to work under deadlines; strong organizational skills required

Regulatory Affairs Associate Resume Examples & Samples

Authors, coordinates, collects and prepares documentation packages for US drug submissions, periodic updates, and compliance submissions to regulatory agencies. Organizes regulatory information resources and tracks and controls submissions. Reviews and advises on labels, labeling, protocols, and (CMC) changes for compliance with regulatory filings
Demonstrated working knowledge of scientific principles and domestic regulatory requirements
Experience working in CMC and post-approval changes desired
Very detail oriented, well organized, and driven to meet deadlines and program goals

Principal Regulatory Affairs Associate for Medical Devices Resume Examples & Samples

Responsible for the day-to-day oversight and management of assigned projects. Serves as the primary regulatory resource for change to and prioritization of projects, resource assignment and efficient management of the development and change processes
Has wide-ranging experience, and uses professional concepts in developing resolution to critical issues and broad design matters
Understands and interprets U.S. and international medical device regulatory requirements, provides guidance on requirements to product development teams
Develops strategies for submissions to FDA and other regulatory agencies. Provides regulatory risk assessments and options to product development teams and management
Assists in short and long-term schedule planning for the product development team
Responsible for preparing FDA submissions necessary for new product approvals/clearances which include Premarket norifictoins-510(k)s, Premarket Approval Applications (PMAs) and supplements, Investigational Device Exemptions (IDEs) submissions
Responsible for the preparation of Regulatory Assessment and Notes to File for assigned projects
Coordinates preparation of additional information and data requested by regulatory agencies and prepares appropriate responses to such requests
Independently reviews and approves relevant documents, including engineering changes, advertising and promotional materials and product development reports
Develops and maintains regulatory procedures and policies to ensure ongoing compliance of existing and new products
Assists with regulatory agency interactions
May provide leadership and direction to assigned resources. Provide timely and appropriate performance feedback
Experience should include effective interaction with manufacturing, quality, clinical/medical and marketing departments
Prior 510(k) experience required
Previous supervisory experience a plus
Demonstrated ability to independently manage multiple projects
As self-starter with the ability to work independently and as a Project Leader who will manage projects and and allocation of resources to those project
Very detail-oriented, well-organized and driven to meet deadlines and program goals
Strong verbal and written communication skills, including the ability to make effective and persuasive presentations
Good computer skills with knowledge of Microsoft Office

Principal Regulatory Affairs Associate for Medical Devices Resume Examples & Samples

Disposable Medical Devices
Medical Device Software
Biocompatibility Standards and Material Qualification
Responsible for preparing FDA submissions necessary for new product approvals/clearances which include Premarket Notifications-510(k)s, Premarket Approval Applications (PMAs) and Supplements, Investigational Device Exemptions (IDEs) submissions
Good computer skills with knowledge of Microsoft Office.HARRM

Regulatory Affairs Associate Resume Examples & Samples

"Combination" Medical Device/Pharma/Disposables Products
Biocompatibility Standards and Material Qualification
Disposable Medical Devices
What will you do at Fresenius?
PRINCIPAL DUTIES AND RESPONSIBILITIES
Experience in the medical device or related industry with demonstrated knowledge of scientific principles (e.g., R&D, Quality)
Understands US and international medical device regulatory requirements
Very detail-oriented, well organized, and driven to meet deadlines and program goals
Strong verbal and written communication skills, Good computer skills with knowledge of Microsoft Office

Regulatory Affairs Associate Resume Examples & Samples

Coordinates, compiles and organizes basic information necessary for the preparation of regulatory documentation packages for review and submission to regulatory agencies
Assists in the preparation of FDA submissions for medical device clearances, including 510(k)s, PMAs and IDEs
Reviews documentation for accuracy, completeness and compliance with applicable regulations and requirements
Under close supervision, investigates issues identified during reviews, obtaining additional information and documentation as necessary
Monitors submissions to ensure adherence to established/proposed timelines
Researches, develops and recommends submissions strategies
Monitors and maintains regulatory files in good order
Maintains current knowledge of device regulations, guidance and standards applicable to Fresenius Medical Care device product submissions. Analyzes the information and provides updates
Participates in departmental improvement activities. Makes recommendations for process improvements to improve efficiency and accuracy of device submissions and other procedures
A self-starter with the ability to work independently with minimal supervision and as part of a small team
Good computer skills with knowledge of Microsoft Office

Regulatory Affairs Associate Resume Examples & Samples

As regulatory representative for assigned clinical studies, provides representation for study-level regulatory activities and updates in study team management meetings, supports clinical trial application activities, reviews and approves investigator document packages including FDA submissions, and manages other regulatory aspects of study as directed
Manages and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding unfulfilled conditions/commitments
Collaborates with Project Team representatives in planning of regulatory documents including responses to Health Authority queries. Supports processes by which regulatory submissions are reviewed, finalized, and signed-off
Manages tracking of regulatory/ethics submissions and approvals across all studies
Manages document archive processes
BA/BS degree in the biological or physical sciences preferred
Relevant pharmaceutical industry experience including experience in regulatory affairs. Minimum requirements are flexible
Knowledgeable of international pharmaceutical guidances, regulations, drug development process, and industry standard practices
Proficient in written, oral, and interpersonal communications in English
Ability to work in close collaboration with colleagues in regulatory department and throughout the development organization
High attention to detail; ability to organize, prioritize, and delegate assigned projects
Experience interacting with CROs in the management of US eCTD IND submissions and ex-US

Regulatory Affairs Associate Resume Examples & Samples

Under minimal supervision, prepare amendments, annual reports, supplements for FDA submissions
Review and submit change requests to management regarding any changes to regulatory documents. Provide input to support the assessment for changes regarding all manufacturing/testing facilities for the US market
Assist management in developing the appropriate regulatory strategy on CMC issues for upcoming projects
Under minimal supervision, may represent Regulatory Affairs on team projects, as they gain knowledge regarding FDA regulations
Bachelor’s degree in a scientific discipline
Minimum 3 years pharmaceutical industry experience and a minimum of 2 years regulatory affairs experience and/or quality control or R&D experience in the pharmaceutical industry
Basic computer skills such as Word, Excel and familiarity with internet
Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities

Regulatory Affairs Associate Resume Examples & Samples

Execute regulatory submissions to ensure timelines are met according to global strategic plans
Participate in cross-functional teams by working closely with product development engineering, marketing, clinical, and quality functions
Identify opportunities to implement process and procedural improvements to drive efficiency within a growing digital health organization
Define regulatory responsibilities within a Scaled Agile Framework (SAFe)
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
Review publications, articles, and regulatory authority guidance in order to expand knowledge of regulatory and technical developments specifically for software
Creatively reconcile global regulatory requirements for both consumer and medical software products
Strategically communicate with global teams to efficiently prioritize and execute regulatory strategies
Be willing to work with a Lean team and wear multiple hats to create smart strategies for regulatory submissions and an expanding Quality Management System

Senior Regulatory Affairs Associate Resume Examples & Samples

4) Respond to regulatory authorities questions with strict deadlines
6) Develop regulatory project plans
9) Represent or lead Regulatory Affairs in small project teams
10) May review promotional material for compliance with local regulations
4) Negotiation skills
6) Manage multiple projects and deadlines
8) Bachelor?s degree or country equivalent in pharmacy or related scientific discipline with a minimum of 2 years regulatory or equivalent experience within a pharmaceutical company, CRO, or similar organization
9) Higher degree/PhD will be an advantage

Regulatory Affairs Associate Resume Examples & Samples

Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience
Bilingual in English and another Asian language
Eligible to work in Hong Kong
Drug development knowledge with understanding of other functions, including Pre-Clinical, Clinical, Development Operations
Strong knowledge in regulations in HUB and appropriate spoke countries
Strong understanding of local country regulatory and safety reporting requirements
Strong understanding of ICH guidelines
Strong computer literacy, including word processing, presentation, and spreadsheet applications
Proficient project management skills
Ability to manage team(s) to accomplish increasingly complex, specific projects
Ability to influence and motivate others outside of direct line of authority
Strong ability to interact effectively with all levels
Ability to navigate through a complex team or matrix environment
Quick learner; proactive; takes initiative
Results oriented and goal driven
Ability to organize, interpret, communicate and/or present team information within a function/department and occasionally to external groups (e.g., TA heads, review boards)
Demonstrates willingness to put in extra effort when necessary to pursue tasks to conclusions

Regulatory Affairs Associate Director Resume Examples & Samples

Directs the regulatory submission process; manages the authorship and publication of electronic submissions. Manages systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process. May author and publish electronic submissions
Directs the development of dossiers for registration of products
Assigns Regulatory Affairs (RA) professionals to serve on development project teams as core team members; communicates regulatory strategy for new products
Directs development and review processes for proposed labeling for compliance with applicable regulations
Reviews, evaluates, and approves promotion and advertising material for compliance with applicable regulations
Oversees 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 of the product. May provide support or supervision to processes
Interprets and applies regulations to business practices and provides regulatory input, advice, and guidance to the organization
Establishes and/or approves Zimmer Biomet RA policy and procedures and ensures compliance with them; may include training RA team or cross-functional groups
Communicates with all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of products
Communicates with (or assigns others to communicate with) Regulatory and/or governmental agencies
Responsibility for establishing prioritization of departmental tasks and projects
Directs and oversees the work of regulatory professionals, including training, mentoring, and ensuring professional development
Serves as a departmental knowledge resource, counseling, advising, and training on all/most facets of departmental function
Participates in the administration of the department by assisting with strategic planning, budget preparation, participation in corporate projects, and other administrative projects as are assigned
Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including Regulatory agencies, superiors, peers, and direct reports
Strong attention to details, and ability to multitask
Ability to manage projects of various sizes, constitutions, and management of personnel
Mastery of relevant Regulations, and ability stay abreast of regulations pertinent to medical devices, biologics, drugs, combination products and IVDs as applicable
Mastery of product knowledge and industry history
Mastery anatomic knowledge
Able to identify and assess business risks and develop Regulatory strategy
Ability to negotiate with Regulatory agencies, management, and other groups as necessary. Ability to building relationships between RA and other parts of the organization
Ability to lead a team, influence others and, through strong organizational skills, handle increasing levels of responsibilities
Management and direct supervision of personnel. Ability to make independent decisions on resources and performance
Strong tactical and strategic thinking skills and administrative and leadership ability
Advanced knowledge of overall business environment, the orthopaedic industry, and the marketplace
Advanced knowledge of FDA and EU regulations (including labeling regulations) and regulations outside the US/EU
Bachelor’s Degree (or non-US equivalent) required. Degree or background in life sciences, technical (engineering) or related field preferred
Advanced degree strongly preferred
Regulatory Affairs Certification (U.S. or EU) preferred
The entrant should have 8-10 years prior RA experience
The incumbent’s regulatory background should include the medical device area, and preferably should include orthopaedic experience
Experience in the areas of drug, biologics, and combination products regulations is also desirable
A minimum of two years of experience managing direct reports
A combination of education and experience may be considered

Regulatory Affairs Associate Resume Examples & Samples

The Regulatory Affairs Associate is responsible for one or more of the following functions
Coordinating manufacturers’ recalls for products sold by HSI. Providing guidance to buyers, warehouse staff, IS staff, and customers on handling product recalls, to ensure the process is conducted accurately and expeditiously for both wholesale and retail
Analyzing manufacturer information and participating in compliance activities with manufacturers and HSI buyers for product replacement or return of recalled items
Developing and maintaining an efficient product recall system and record keeping
Assisting in the maintenance of the adverse reaction system, where information is collected from customers on any product that has caused serious illness, injury, or fatality. Also with the report of information appropriately to the FDA and equivalent European regulatory agency as necessary
Assisting in the maintenance and recording of customer comments and complaints for Corporate Brand Products. Colaborates in providing a trend analysis to the Corporate Brand Development Group to track product quality issues
Monitoring the compliance with DOT requirements for the classification, storage and distribution of Hazardous Materials. Ensuring ongoing compliance with Federal and State environmental laws, including the registration and disposal of pesticides and other type of type of chemical products. Coordinates the implementation of policies and procedures to ensure compliance with OSHA regulations
Conducting routine Regulatory audits of HSI facilities, affiliates and subsidiaries
Researches applicable Federal, State and Local regulations; develop and implements the necessary policies and procedures to ensure the Company’s ongoing compliance with recent changes
Assists with the contacts and consults with Federal, State, and local government agencies (i.e., FDA, DEA, EPA, DOT, FAA, and State Pharmacy Boards) and International Regulatory agencies to obtain appropriate documentation to update and acquire company licensing in order to handle, store, ship, and repair regulated products and equipment
Develops appropriate training programs for distribution center staff consistent with regulatory compliance policies and procedures. Assists Distribution Centers during government inspections, and reviews inspection report observations, generates appropriate and timely response; and implements proper corrective action
Participates in special projects and performs other duties as required
Provides support to Corporate Brand Development Group, Marketing and the Business Units answering questions pertaining to regulatory issues, such as MSDS, FDA, product classification, registration and disposal, and other DOT, FAA, EPA and OSHA related matters
Product Item Master Data Review
Meeting company standards pertaining to quantity and quality of work performed on an ongoing basis, performing all work related tasks in a manner that is in compliance with all Company policies and procedures including WorldWide Business Standards

Senior Regulatory Affairs Associate Resume Examples & Samples

Bachelor’s degree with at least 4 years of professional experience in the medical device industry is required
Thorough knowledge of FDA and international regulations pertaining to the design, manufacture and commercialization of medical devices is required
Demonstrated proficiency with worldwide regulatory planning/strategy and submission planning/preparation is required
Proven proficiency with PC-based productivity applications, including Microsoft Word, Excel, PowerPoint and Project is required
Experience in project team participation and domestic submissions is required
Strong regulatory and clinical writing skills required
Demonstrated ability to analyze complex regulations and guidance documents is required
Advanced degree in a related field is preferred
A basic understanding of sinus disease and treatments is preferred7884170413

100

Regulatory Affairs Associate Resume Examples & Samples

Prepare, assemble, review and/or evaluate, publish and archive new ANDA and life cycle management regulatory submissions in accordance with local regulatory requirements and guidelines
Prepare paper based and electronic submissions, including both eCTD and non eCTD formats, for multiple project to regulatory agencies, and ensure the timely delivery of quality submissions
Critically review submission documentation and provide input to respective departments for necessary revisions
Coordinate and prepare responses to FDA Deficiency Letters and other agency requests
Using eCTDXpress complete submission publishing for submission through ESG

101

Regulatory Affairs Associate Resume Examples & Samples

Performs quality control on documents to be submitted to the TMF
Identifies missing documentation and follows-up with authors or other stakeholders to obtain missing items; performing quality reviews of files and any needed remediation (e.g., follow-up with sources, generating notes to file to explain any discrepancies); and completing file review documentation
Responsible for ensuring timely filing of TMF documentation; addressing backlog of unfiled documentation; performing periodic review and remediation of TMF
May participate in Inspection Readiness activities as needed
May perform document approval and notification processes
Knowledge of and direct experience with Trial Master File required
Ability to multitask in a fast-paced environment
Ability to prioritize while adhering to project deadlines
Good understanding of the biotechnology/pharmaceutical industry and the clinical development process, preferred
Familiarity with Regulatory Clinical Trial Applications, preferred

102

Senior Regulatory Affairs Associate Resume Examples & Samples

Support the execution of regulatory CMC strategy for late development and post marketing submissions and escalate potential challenges
Manage the regulatory CMC aspects of projects/products, including documentation submitted to regulatory agencies and regulatory agency interactions. Ensure that the documentation is complete and complies with applicable regulatory requirements
Work effectively on cross-functional teams and be the regulatory CMC contact for assigned projects
Support the authoring and/or review of CMC submission components
Coordinate CMC submission activities with global colleagues for timely submissions and approvals
1+ years of experience working in regulatory affairs CMC

103

Regulatory Affairs Associate Resume Examples & Samples

Work with Quality team to assist with establishing and maintaining compliance with FDA QSRs (GMP), including company registrations and new product submissions, coordinating with Quality team to establish FDA communication/channels for compliance on medical device listings/classifications
Assist Quality team as needed
Work with the Quality team to establish and maintain compliance with the EU IVD directive and other international regulations and standards as required, including registrations
Maintain Technical Documentation files in compliance with international requirements
Work with existing Quality team members to ensure compliance of labeling and advertising for all products in a regulated class
Support the QMS training program, including regulatory requirements
Assist with monitoring and trending key quality objectives for Senior Management review meetings
Participate in internal audits
Support Management Review with metrics data on change requests and Quality Documents and support timely document search and delivery during audits
Become familiar with Unique Device Identifier (UDI) elements and assist Quality team as needed with management of UDI regulatory elements
Some travel between Dedham and San Diego may be required
1 year of experience in Regulatory Affairs for Medical Devices
Familiarity with technical writing
Familiarity with ISO 13485 requirements
Previous exposure to international market medical device requirements

104

Regulatory Affairs Associate Resume Examples & Samples

Prepares required local submissions with a certain degree of supervision
Follow up on mandatory requirements for registration: local certifications, importation of samples where needed and local testing, etc
Compiles, prepares and submits regulatory documents and technical files to MoH to obtain approvals for new product registration, renewals & changes
Updates Registered Codes Database, Labeling Database, Scanned Registers and other Regional tools as per approvals received
May request documentation from OCs to prepare registration dossiers
Reviews market licenses and labeling to input RA Sr Specialist/RA Manager to set up product codes status
Active participation and timely delivery results in RA items to achieve common goals or attend common strategies
Represents the RA team in multifunctional projects/meetings
Ensures compliance with local MOH regulatory requirements
Scans the external environment
Supports SR. Specialist & Regional RA team when needed or required
Prepares and approves labeling content
Supervises the work of translation and dossier contractor with the help of Sr. Specialist
Regulatory review of advertising materials
Interacts with regulatory service providers
Identifies and proposes local process improvements
RA approval of supplies needed for supply chain processes (IFUs, local labels,etc)
Ensures compliance with local MOH regulatory requirements as well as CMS and J&J Corporate policies
May identify and communicate new regulatory / legal requirements
Product responsible person in countries where required
Bachelor´s degree in Chemical/Pharmaceutical/Medical Sciences or Biomedical Engineer
Years of Experience: 2-3 years of experience
Required knowledge: Regulatory Environment
Required Experience: Desirable experience in Medical Devices, Pharma background is acceptable
Intermediate English
Location: Mexico City (Santa Fe)

105

Senior Regulatory Affairs Associate Resume Examples & Samples

Acting as FDA liaison for assigned projects
Reviewing and advising on manufacturing and control changes for marketing products, labels and clinical materials
Evaluating and assessing the regulatory impact of proposed design changes to marketed medical devices
Developing strategies for submissions to the FDA and other regulatory agencies and providing regulatory risk assessments and opinions to product development teams
Preparing FDA submissions necessary for new product approval, clearance and product continuance
Preparing Regulatory Assessments and Note-to-File for assigned projects, coordinating the preparation of additional information and data requested by regulatory agencies and preparing responses to such requests
FDA regulations and guidance for medical devices
Preparation of FDA acceptable 510(k) submissions
Preparation of clinical trial requirements to support a clinical study, including requirements for the protection of study participants
21 CFR Part 820 and Part 806 compliance requirements
Reviewing CAPAs to address any regulatory compliance related issues
ISO 14971 and ISO 13485 requirements for regulatory compliance

106

Pharma Regulatory Affairs Associate With CMC for FDA Resume Examples & Samples

Under general supervision, collects and coordinates information to prepare regulatory documentation packages for review and submission to regulatory agencies ensuring compliance with all applicable policies, procedures and regulatory requirements and guidelines
2 – 5 years’ related experience; or an advanced degree without experience; or equivalent directly related work experience
A self-starter, with the ability to work independently, and as part of a team
Strong verbal and written communication skills including the ability to make effective and persuasive presentations
Strong computer skills with working proficiency of Microsoft Office. Microsoft project and experience with word templates a plus
Prior experience with eCTD submissions preferred. Basic knowledge of CTD required

107

Regulatory Affairs Associate Resume Examples & Samples

Coordinate and assist in the preparation of technical documentation for use in regulatory submissions worldwide
Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway
Identifies and investigates solutions to procedure and process related issues. Revises the procedure or process as needed to increase efficiency and compliance
May aid in regulatory direction to development project teams as a core team member
Creates, maintains and monitors appropriate metrics to measure key performance indicators of the unit
Reviews proposed labeling for compliance with applicable international and country regulations
Documents and maintains records in accordance with corporate and site specific procedures
Reviews and evaluates promotion and advertising material for compliance with applicable regulations
Ensures Field Notices and Compliance Requests are distributed to required countries and responses are received on time and accurate
Support international regulatory compliance activities based on a specialized approach and best practices
Focus on Latin America Regulatory Compliance and liaise among distributors, subsidiaries, Regulatory Compliance, Customer Service, and Quality Assurance
Facilitate communications among functional areas and distributors, recalls, field notifications, product returns, fill out forms, collect and communicate information, process decision trees, traceability control, audit support, supplemental labeling in compliance with local regulations, distributors audits, complaints processing, and required EtQ maintenance
Supports and reviews proposed changes for impact on regulatory status of the product
Follows Zimmer Biomet RA, corporate, and site specific policies and procedures
Knowledge of EtQ, JD Edwards, Microsoft Office applications and the ability to learn other software quickly as required
Ability to consistently meet high standards of input accuracy, produce quality documents, compile data, and perform simple analyses with accuracy
Good decision making skills and proven ability in balancing priorities among the many ongoing tasks, and being responsive to critical situations, as this position has a high volume of work, regulatory mandated time limits, and often changing priorities
Action-orientated: Ability to take initiative to correct problems or make changes for improvement without waiting for direction
Proven ability to work in a team setting. Willing to share the load and participate in projects outside of normal job scope. Ability to work closely with others to assure functional commitments is met
Proven ability to provide training to Distributors and Internal and external customers, and team members to meet time sensitive projects
Quality, Compliance, Regulated Environment work experiences preferred
Co-op or Intern experience in medical devices, preferred

108

Regulatory Affairs Associate Resume Examples & Samples

Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
May aid in regulatory direction to development project teams as a core team member; supports regulatory strategy for new products
Support development of package inserts
Supports and reviews proposed product changes for impact on regulatory status of the product

109

Regulatory Affairs Associate Resume Examples & Samples

Proactively develops action plans and implements all activities, to achieve the timely and efficient registration of high quality submissions (market authorizations and post-market variations) for all assigned BI veterinary products
Leads interactions between Canadian/international BI personnel and the Canadian Animal Health Authorities (CFIA & VDD)
Ensures entry and quality of product documentation for Canadian AH products in corporate systems
Ensures compliance of all permits and registrations required for the importation and distribution of BI animal health products in Canada, in coordination with the QA group for pharmaceutical products
Ensures compliance and performs quality inspections and releases for veterinary biologics and Low-Risk Veterinary Health Products
Prepares and leads BICL AH participation in quality inspections from regulatory agencies and from Corporate for veterinary biologics
Supports global manufacturing and Canadian QA group in the assessment of proposed Change Controls
Bachelor's degree (Biochemistry, biology, chemistry, or simliar) or specialized degree (veterinary medecine, pharmacy or similar)
Excellent Project Management skills, i.e. superior organizational, written and oral communication skills, the ability to work independently as well as to collaborate effectively with team members locally and internationally to meet strict deadlines
Thorough knowledge and understanding of Canadian regulations/guidelines concerning development, manufacturing and distribution of pharmaceutical and biological products (GMP’s, Food and Drug Regulations & CFIA regulations)
Good working knowledge of business office software applications including Microsoft Office Word, Excel, PowerPoint and capacity to be trained to use specialized databases
Basic knowledge of medical terminology
Strong interpersonal, networking and negotiation skills (note: this is essential)
Bilingual skills (English/French) would be an asset

110

Regulatory Affairs Associate Resume Examples & Samples

Develop and maintain product labeling in compliance with laws and regulations
Execute regulatory labeling activities to ensure that the established project plan due dates for milestones are met
Contact Regulatory Agencies or outside consultants to resolve regulatory labeling issues
Process change requests in compliance with internal SOPs and related regulations
Maintain regulatory files and data systems in compliance with internal SOPs
Represent regulatory affairs in project meetings
Gather, analyze and summarize technical and research information and regulatory updates. Present information to department members, verbally and in writing, to ensure department members are informed promptly
Prepare and maintain project plans; work with department members to monitor progress and identify any barriers to project completion
Must possess analytical skills and the ability to identify and apply policies and general regulations to specific products or projects
Ability to monitor, analyze, raise awareness, and assess impact of regulatory issues with support of Supervisor
Good verbal and written communication skills are necessary
The ability to participate on project teams is required
Basic knowledge of scientific, regulatory, and legal terminology is necessary
1-2 years working experience
Bachelor degree required. Bachelor degree in a health sciences field preferred. Experience in the health care or food industry preferred. Experience in regulatory affairs preferred

111

Regulatory Affairs Associate Resume Examples & Samples

Assist the Canada, Asia and Latin America Region Regulatory Affairs team in the following activities
Preparation of applications for official certificates and related documents to support regulatory processes in Canada, Asia and Latin America
Coordination of legalization processes for official certificates and related documents to support regulatory processes in Canada, Asia and Latin America
Review of labels and packaging components to support regulatory processes in Canada, Asia and Latin America
Coordinate the translation of documents for the preparation of registration files
Update of product registration database
Team worker, self-motivated proactive behavior
Ability to perform assigned responsibilities with minimal supervision
Understanding of regulatory procedures and documents as well as official regulations and guidelines
Oral and written skills to clearly convey information to regulatory teams in Canada, Asia and Latin America
Bachelor's degree in Veterinary Medicine, Pharmaceutical Sciences or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
This position requires U.S. citizenship or permanent residence status

112

Senior Regulatory Affairs Associate Resume Examples & Samples

Write / review CMC sections
Prepare briefing documents for agency meetings
Attend customer meetings and project team meetings
Devise and maintain regulatory project plans in line with best practice recommendations
Update functional leads and maintain transparency of information across regulatory function
Provide regulatory support and advice for external customer in line with defined Regulatory plans and in response to ad-hoc questions

113

Regulatory Affairs Associate Resume Examples & Samples

Bachelor's degree in a scientific field
3+ years of experience in Regulatory Affairs
Experience with generic (ANDA) filings

114

Regulatory Affairs Associate Resume Examples & Samples

Identify and collate technical documentation as required by Annex II of the EU Medical Device Regulation 2017/745 including, but not limited to design and risk documents, verification/validation documents, standards conformance, and labeling
Identify and adhere to policies, procedures and work instructions which support technical documentation activities
Provide support for Clinical Evaluation Reports including references to required documentation
Align technical documentation according to the structure proposed by the MDR team
Prepare technical documentation for submission to and review by Notified Bodies, as required
Monitor and report to Joint Reconstruction RA management team on the progress of conversion of files to meet MDR requirements
Liaise with Joint Reconstruction RA management team and MDR team to escalate concerns related to the ability to comply with requirements and timelines
Ability to work with cross-functional team members including (but not limited to) R&D, Quality, Labeling, Sterility, Medical and Clinical
Experience in working with Product Lifecycle Management (PLM) systems (i.e. Agile and Windchill)
Strong proficiency in Microsoft Office including Word and Excel
Languages: English required, German a plus
Ability to manage multiple tasks and be detail-oriented
Strong working knowledge of EU Medical Device Regulations and guidance documents as well as relevant standards

115

Regulatory Affairs Associate Resume Examples & Samples

Support new product introduction by assessing product compliance primarily for NICNAS/NZ EPA. Preparation of SDS and regulatory label text will also be a requirement
Develop and maintain documentation relevant to regulatory compliance. Prepare and file regulatory documents
Pursue continuing education and develop advance knowledge of regulatory requirements
Identify, assess and implement required regulatory changes

116

Regulatory Affairs Associate Resume Examples & Samples

Interpret regulatory requirements and determine strategy to obtain registrations. Independently make decisions regarding work processes or operational plans and schedules in order to achieve department objectives
Represent Ortho to domestic and international regulatory agencies. Interacts with agency and affiliate personnel to expedite pending applications, resolve regulatory matters and manage development meetings for regulatory submissions. Works independently to identify and obtain data needed to support regional regulatory strategies
Provide guidance to business partners regarding regulatory requirements including indications of risk and approximate timing for approvals for planning purposes
Complete administrative activities related to maintaining compliant regulatory status for currently marketed products, which includes the maintenance of technical and design history files, review and approval of labeling and promotional materials and regulatory assessment of changes. Participate in departmental initiatives, such as process improvement and streamlining
Degree level educated
Minimum 2 years’ progressive experience gained within a regulated healthcare industry
Sound working knowledge of Microsoft Office, Word and Excel
Degree in a scientific discipline
Regulatory affairs experience in a medical device/IVD regulated industry
#LI-JS1

117

Regulatory Affairs Associate Resume Examples & Samples

Format, assemble and prepare regulatory documents for submissions and other regulatory correspondence
Support the Change Control Process Program
Attend cross-functional meetings to represent Regulatory Affairs
Interact with individuals and external customers outside the RA department for the purpose of tracking the progress and obtaining materials/documents to support Regulatory Affairs in the preparation of required submissions and/or annual reports
Assist in regulatory submission planning
Review regulatory documents for submission readiness
Ability to work independently with minimal oversight as well as collaboratively with cross functional teams
Demonstrated capabilities with an emphasis on details and quality

118

Regulatory Affairs Associate Resume Examples & Samples

Responsibility for the maintenance of registered products ensuring product compliance
Working closely with local brand teams and global groups to proactively manage responses to questions received from the Australian Regulatory Authorities (TGA) and Medsafe (NZ) within an agreed priority and timeframe
Providing input and expertise to assist commercial, technical and marketing teams with new product initiatives and activities
A science based degree
First-hand experience with regulatory submissions in Australia and New Zealand
Experience and subject matter expertise in regulatory affairs within the pharmaceutical industry specifically in the area of prescription medicines (rather than generics)

119

Regulatory Affairs Associate With Class Resume Examples & Samples

Software Driven Medical Devices
Class II/Class III Medical Devices
Evaluate and assess regulatory impact of proposed product changes
Understand and interpret U.S. and international medical device regulatory requirements; provide guidance on requirements to assigned product development teams
Develop strategies for submissions to FDA and other regulatory agencies. Provide regulatory risk assessments and options to product development teams
Responsible for preparing FDA submissions necessary for new product approval/clearance and product continuance
5 – 8 years’ related experience; or a Master’s degree with 3 years’ experience; or a PhD without experience; or equivalent directly related work experience
Strong understanding of medical device guidelines and regulations
Demonstrated working knowledge of scientific principles
A self-starter with the ability to work independently and as part of a small team
Strong interpersonal, verbal and written communication skills, including the ability to make effective and persuasive presentations

120

Regulatory Affairs Associate Resume Examples & Samples

5 years regulatory affairs experiences in pharmaceutical or biotech industry
Working experience with multinational company
Experience with clinical trial application and/or new drug applications
Familiar with regulatory guidelines and requirements
Good communication skill, team work
Fast learning capability

121

Regulatory Affairs Associate for Operations Resume Examples & Samples

You will work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
You will be expected to exercise solid judgment in selecting methods, techniques and evaluation criteria for obtaining results
You will add to your knowledge base by networking with key contacts outside your own area of expertise
Ability to influence and partner with cross-functional teams
Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
Demonstrated ability in analytical reasoning and critical thinking skills
Strong capability to contribute and lead in a team environment
Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
Excellent communication skills; both oral and written
Strong interpersonal skills with the ability to influence others in a positive and effective manner through technical excellence and mutual respect
Demonstrated ability to contribute to a continuous learning and process improvement environment
Capacity to react quickly and decisively in unexpected, fluid situations
Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
Focused ability to influence operational excellence and performance metrics
A risk averse nature when needed, with the ability to identify potential solutions to complex problems
Developing professional expertise; applies company policies and procedures to assist in the day-to-day procedures used to support regulatory submission (drugs and device) and publishing activities
Assists in the maintenance of an archiving/document management system
Responsible for producing and tracking FMCNA regulatory submissions and submissions-compliant documents in the electronic format (eCTD and eFiling)
Responsible for assisting in implementing and maintaining various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory information system, and electronic submissions
Works with department and external groups as assigned
Participates in the evaluation and provide input for new department technologies and collaborate with intra-departmental resources to ensure adherence to infrastructure standards
Compiles, publishes, QC, and validates documents for FDA submission
Provides editing and formatting support
Supports the transition from legacy to electronic submissions
Coordinates with regulatory staff to compile regulatory submissions
Ensures that all required documents are received and formatted appropriately and in a timely manner
Demonstrates knowledge of electronic submission requirements and prepares for future initiatives and requirements
Participates in a document management system to align document access and storage with RA electronic submission needs
Assists in development of overall project timing
Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors
Builds productive working relationships
2 – 5 years of experience in a Regulatory Affairs environment; 2+ years in pharmaceutical industry
Experience with Document Management a plus
Understanding of document management processes in a regulated pharmaceutical/device environment
Demonstrated ability to work to manage projects as part of a team
Must be highly proficient in MS Office (emphasis on MS Word), Adobe Acrobat (version 5.0 or higher)
Knowledge of EDM, RIM and electronic publishing software preferred. Experience with electronic submissions, specifically eCTD, or eCopy a plus
Detail oriented, proactive, effective task planning and coordination of activities
Experience with Adobe, desktop publishing software, document management solutions, database software and Microsoft Office
Detail oriented; ability to work under deadlines; strong organizational skills required

122

Clinical Regulatory Affairs Associate Resume Examples & Samples

Receive documents from various sources and review for completeness and suitability for submission to FDA. Request missing and/or illegible pages, arrange for translations as needed
Review regulatory documents to assure FDA requirements are met and are ready for submission. Responsible to handle the release and shipment of investigational drug supplies to the investigators participating in the clinical studies. Including assuring the regulations and laws regarding IND submissions and financial disclosure meet compliance
Assure CMC and QA have approved the product, and that the labeling of the product meets the regulations for interstate shipment. Handle drug re-supplies for the above-mentioned studies
Prepare 30-day investigator submissions
Gather information and prepare IND and NDA annual reports. With the manager's guidance, prepares new IND, NDA and SNDA submissions, amendments and supplements
Work with all team members to accomplish tasks and be able to clearly communicate with the team
Needs to do writing for routine submissions
Think of solutions to overcome problems in making submission goals. Review submissions with a critical eye for typos, grammatical errors, pages out of order, etc
Impact of Actions / Decisions

123

Regulatory Affairs Associate Resume Examples & Samples

Matric certificate
1- 2 years experience in a pharmaceutical regulatory environment
Basic scientific and medical knowledge
Knowledge and experience of Regulatory Affairs in markets in South and Southern Africa will be an advantage
Ability to prioritise and work on tight deadlines
Detail orientated and organised
Excellent computer knowledge
Assist with all activity relating to the compilation, submission and maintenance of registration application dossiers to South Africa and Southern African Regulatory Authorities, in accordance with established formats. Where technical support is required, the regulatory pharmacists/officers will facilitate and provide support
Preparation of the copies of the dossiers prior to submission
Assist with the evaluation of artwork and initiation of artwork changes where relevant. Maintain related database to ensure that tasks are completed effectively
Liaising with the in-country agents and Regulatory Authorities
Ensuring that the filing system and archiving for both electronic and hard copies are current and in order
Performs peer review of data packages prior to submission, if required
Provides support to RA department including but not limited to payments, taking minutes at meetings, maintenance of databases (Global and local)
Compiles a Monthly Report reflecting
All submissions processed with the respective South and Southern Africa Regulatory Authority with time allocated to each item
The updated status of all on-going projects with time allocated to each item
Delivery against KPI targets

124

Regulatory Affairs Associate Resume Examples & Samples

Compile and manage product registration data for all divisional product lines
Review source system to determine accuracy, audit data for discrepancies, correct errors where appropriate
Input information in pre-described formats; verifying data entry ensuring accuracy and completeness of information
Updates records to include deleting, changing or additions to Regulatory Affairs data files
Produces database summaries and reports/data extracts as requested
Evaluate processes for gaps, inefficiencies and additional opportunities and provide suggestions for improvement

125

Regulatory Affairs Associate Resume Examples & Samples

Ensure compliance in all Nordic countries
Degree in chemistry or a science minimum a BSc
Experience within an FMCG environment, or with eco-labels is desirable
Experience in cosmetics regulations is desirable
Knowledge of regulation of detergents, cosmetic products and biocides in the Nordic Region will be an advantage
You thrive in a dynamic environment such as this fast growing business area within Reckitt Benckiser and you quickly adapt to changes
Taking responsibility for your own projects and tasks you are able to prioritize your work and competing deadlines
Good communication skills both written and oral (in English, Danish and preferably Swedish or another Nordic language)
Clear and logical thinker with the ability to recognise patterns and develop innovative solutions
Pro-active self-direction with a high level of initiative and persistence and a very much hands approach to results delivery

126

Regulatory Affairs Associate Resume Examples & Samples

Preparation, submission and maintenance of registration applications to the Therapeutic Goods Administration (TGA) and Medsafe (New Zealand) within the agreed timeframes assigned by the Regulatory Affairs Manager 
Review of existing registration dossiers to identify administrative and technical deficiencies that may influence the likely success or failure of the application; 
Development of strategies to overcome deficiencies in the registration dossiers; 
Liaison with international parent and license companies for the acquisition of documentation, information, product samples and responses to issues raised during re-view/evaluation of registration dossiers; 
Management of regulatory affairs activities associated with the maintenance of registered product portfolio; 
Creation and review of Product Information and Consumer Medicine Information documents for registered products; 
Provide technical and/or strategic regulatory advice to internal cross-functional teams; 
Preparation of the regulatory data set for applications to the Pharmaceutical Benefits Branch for product reimbursement; 
Management of regulatory processes to point of market launch; 
Provide support for the preparation and set-up of bioequivalence studies; 
Provide regulatory support, technical and/or strategic regulatory advice for product development and pre-submission activities
Other responsibilities for the position include participation in departmental meetings, establishment of a good rapport with local TGA regulators and Medsafe regulators

127

Senior Regulatory Affairs Associate Resume Examples & Samples

Review of existing registration dossiers to identify administrative and technical defi-ciencies that may influence the likely success or failure of the application
Liaison with international parent and licence companies for the acquisition of docu-mentation, information, product samples and responses to issues raised during re-view/evaluation of registration dossiers; Creation and review of Product Information and Consumer Medicine Information documents for registered products
Provide strategies with respect to necessary bioequivalence studies; to organize local bioequivalence studies, and preparation of such studies, eg provide guidance on study design and study conduct to international study centers; assisting HQ in conducting global BEQ studies where applicable. Other responsibilities for the position include participation in departmental meetings, estab-lishment of a good rapport with local regulators and Medsafe regulators, provide training to sales department where required, participation in various industry forums on the local regulatory environment, to provide support to other department , in particular Quality Assurance as required. The position will also assist the Regulatory Affairs Manager/Regulatory Affairs Team Leader in miscellaneous tasks on an as required basis

128

Regulatory Affairs Associate Resume Examples & Samples

Acts as company representative, developing and maintaining positive relationships with government agencies through oral and written communications
Review, register and maintain Market Labels for compliance with various regulations in relationship to product formulations
Maintains regulatory knowledge of EPA and State agency guidelines and regulations
Review and sign off on finished label artwork for compliance with various regulations
Provide support to consultants, category managers and internal departments
Responsible for filing the various annual, semi-annual and quarterly compliance documents to the appropriate state agencies
Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking documents submitted to both federal and state agencies
Participates in activities to create and improve regulatory processes and systems
Assists in developing procedures to ensure regulatory compliance
Assists in the development of regulatory metrics and project tracking
Serves as a member on manufacturing and development teams, providing regulatory feedback and guidance, and coordinating team inputs for submissions
Execute departmental policies and procedures
Supports technical or business initiatives and special projects
Serves as an alternate company representative for all pesticide Federal registrations
Minimum of 2 years’ experience in regulatory affairs field preferred
Ideal candidate will be familiar with EPA, CA Prop 65, and VOC Regulations
Ability to read, analyze, comprehend and apply general business periodicals, professional journals, technical procedures, or governmental regulations
Excellent organizational abilities and communication skills
Must be proficient in Microsoft Operating platforms and associated Office suite programs that may include but not limited to Outlook, Word, Excel and Power Point
Must have above average spelling and grammar along with strong written and verbal communication skills

129

Regulatory Affairs Associate Resume Examples & Samples

Assist with the development and execution of clinical research studies and programs
May provide literature searches, registry data or study results for annual reports, notified bodies or other internal and external needs
Ability to read technical (medical reports) and understanding of medical terminology/research
Experience in a clinical research environment a plus

130

Regulatory Affairs Associate Resume Examples & Samples

70%
Excute the successful preparation and submission of investigational applications, market applications, variation, post approval reporting obligations and general product life cycle management, including support to marketing companies and submission partners, including coordinating the registration documents request
Ensure compliance of regulatory files, including appropriate documents archive
Evaluate regulatory registration requirements for Saudi Arabia prepare regulatory assessments reports, prepare projects plans, timelines and related project fees
Science degree required, higher degree preferred
At least 2-3 years regulatory experience in international regulatory affairs Excellent working knowledge of SFDA pharmaceutical regulations
Be pro-active,
Accountable
Must be able to work in a fast paced environment with demonstrated ability to deal with competing tasks and demands
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

131

Regulatory Affairs Associate Resume Examples & Samples

Prepare regulatory submissions in electronic Common Technical Document (eCTD) format, working with the functional teams
Create and maintain submission timelines, track submission activities and eCTD documents
Catalog, archive, and maintain regulatory communications with regulatory agencies
Lead in the preparation of Annual Reports and other regulatory submissions
Manage special regulatory projects with supervision
Support preparation of responses to queries from regulatory authorities, coordinate reviews with functional teams, and prepare the electronic submission
Perform overall quality review of regulatory submissions and ensure information is accurate and complete
Establish processes and write departmental guidelines and standard operating procedures (SOPs)
Excellent written and verbal communication skills, problem-solving abilities, critical/analytical thinking skills
Ability to plan and manage multiple projects, meets deadlines under pressure, and accommodate changing priorities and assignments
In-depth knowledge of FDA requirements for eCTD submissions
Experience with electronic publishing systems and templates
Must have a high level of attention to detail and quality
Knowledge of Microsoft Office applications and Acrobat Professional. Expert knowledge of MS Word
Must adhere to regulations, policies, departmental guidelines, and SOPs
Excellent interpersonal skills with the ability to interact effectively with other departments
B.S. degree in a scientific/life sciences discipline with at least 3-5 years regulatory affairs experience in the pharmaceutical/biotech industry. M.S. degree is preferred. Direct experience filing electronic submissions desirable. CMC experience a plus

132

Senior Regulatory Affairs Associate Resume Examples & Samples

Compile complex pre-approval (ANDS/ NDS) and post-approval submissions (NC, SANDS, SNDS) that meet the target dates for submissions to Health Canada. Address deficiencies and help manage the response strategy to listed and potential deficiencies
Communicate effectively with Health Canada and with internal and external clients to support the drug review and approval process
Ensure compliance for a large group of products. Review and accurately assess change controls to determine the appropriate level of change. Maintain Compliance files to keep track of current documents for QA Inspection and product release. Ensure Product Monographs and labeling materials remain current
Prepare Annual Reports and Administrative Submissions within target dates
Liaise with several departments including Global R&D, Operations, Marketing, Quality and Legal to provide regulatory support to achieve high quality submissions that reflect the business needs of all relevant areas of the company
Provide regulatory support for launch activities and provincial formulary listings
Participate or direct special projects in the department to improve efficiency
Provide guidance and support to junior Regulatory Associates on Regulatory matters
Bachelor of Science Degree in one of the life sciences or chemistry with a minimum of 3-5 years of hands-on experience in regulatory submission preparation. Post-Graduate Regulatory Affairs Certificate considered an asset
Sound knowledge of Health Canada regulations and guidelines
Familiarity with FDA and ICH guidelines an asset
Experience with documentation, organizing small projects, working in a deadline environment
Proven ability to learn, correlate diverse data and extrapolate from set examples; documented organizational abilities
Demonstrated time management skills and the ability to prioritize and handle multiple projects is required
Excellent analytical, communication and interpersonal skills
Proficiency with Microsoft Office and Document Management Systems

133

Regulatory Affairs Associate Resume Examples & Samples

Exceptional leadership skills
Proven influence and impact skills across business levels and functions
Strong interpersonal and negotiation skills
Problem identification and solving skills
Competent people manager and able to identify and promote talent
Ability to enable and drive change
Able to work effectively in, spoken English (written and spoken)
Self-starter, able to schedule and progress workload on own
Experience of working with and leading cross-site and multi-functional teams
LI-GSK
Bachelor of Pharmacy and a registered pharmacist in Hong Kong
Fluency in Cantonese and/or Mandarin

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