Regulatory Affairs Officer Resume Samples

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V Kuhic

Vilma

Kuhic

2824 Sanford Ramp

New York

+1 (555) 574 6343

2824 Sanford Ramp

New York

Phone

p +1 (555) 574 6343

Experience Experience

Philadelphia, PA

Regulatory Affairs Officer

Philadelphia, PA

O'Reilly-Buckridge

Philadelphia, PA

Regulatory Affairs Officer

Participate in and provide regulatory support to project teams looking into development and life-cycle management of the products
Perform assigned tasks with the highest quality and in accordance to established internal timelines
Assist the Head of Regulatory Affairs with administrative support including diary, travel, invoices and expenses management 
Working in compliance with relevant Working Instructions and SOPs - as well as current EU and national regulatory regulation
Performs other tasks or assignments, as delegated by Regulatory management
Build respect and trust with customers, both internally and externally, to establish effective and influential working relations
Work as part of a cross-functional team, which has the responsibility to create and maintain CMC documentation for drug substances and drug products

New York, NY

Principle Regulatory Affairs Officer

New York, NY

Boyer, Legros and Crona

New York, NY

Principle Regulatory Affairs Officer

Project managing teams of colleagues involved with the development of new products
Reviewing company practices and providing advice on changes to systems
Working with specialist computer software and resources
Developing and writing clear arguments and explanations for new product licences and licence renewals
Preparing submissions of licence variations and renewals to strict deadlines
Monitoring and setting timelines for licence variations and renewal approvals
Keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to

present

Chicago, IL

Senior Regulatory Affairs Officer

Chicago, IL

Bayer LLC

present

Chicago, IL

Senior Regulatory Affairs Officer

present

May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development
Maintain compliance of regulatory based labelling (Summary of Product Characteristics (SPC), Package Leaflet (PL) and Prescribing Information (PI))
Assist Line Manager in gathering relevant KPI and metrics
Ensure prompt resolution of regulatory issues affecting the Irish business
Communicate significant regulator issues/developments to commercial and the potential impact on the AbbVie Ireland business
Develop and deploy global regulatory strategies and manage the pre-market submission of the Immunodiagostics products as well as assist with the registration of Dartford-distributed products as necessary
Act as the lead RA within a cross-functional project team, providing inputs into New Product Development, changes to existing products and other activities involving the complete life-cycle management of products

Education Education

Bachelor’s Degree in Science Preferably

Tulane University

Bachelor’s Degree in Science Preferably

Skills Skills

Ability to work in various projects in-parallel and know basic project management skills (cross several time-zones)
Excellent verbal and written communication skills, proficient English skills are essential
Proficient knowledge of domestic and international standards
Good, solid interpersonal communication (oral and written) and organisation skills
Good team player
Strong software and computer skills, including MS Office applications
Ability to follow SOPs consistently; provides independent thought to assist in process improvements
Ability to make decisions on discrete tasks under senior supervision
Be able to manage own and peaks of workload
Written and verbal communication skills sufficient to professionally address a wide and varied audience both internally and externally

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Regulatory Affairs Officer Resume Examples & Samples

Maintenance of a regulatory repository that tracks regulatory notices, alerts and changes to industry and firm standards
Work with appropriate business units to assess level of impact of such changes to the firm, areas of the firm impacted, assigned personnel to effect required process, policy and/or systems changes, document status of progress and to document the action(s) required or taken to comply
Provide periodic (monthly and quarterly at a minimum) summaries and reporting to RJF and subsidiary/business unit as well as other managers throughout the organization
Corresponds and interacts with other members of Compliance, home office and business units on relevant issues
Corresponds and interacts with various business units throughout RJF and its affiliates as needed to provide guidance in the development and implementation of policy and procedure changes resulting from regulatory reviews or examination findings. Manages different policies, procedures and responses to key regulatory, financial and other key business risks at the enterprise level (RJF)
Works closely with business units and Compliance to ensure that the rules repository used by the firm is complete and up to date
Assist Chief Regulatory Officer in the maintenance of a central tracking repository for RJF and its affiliates regarding all regulatory examinations, enforcement actions, internal audit findings, Compliance & Standards decisions and regulatory changes as well as performing follow-up to ensure that all items identified are timely remediated. Senior management as well as Legal, Compliance and Information Technology regarding records management needs and resources
Assist with the administration and monitoring of RJF’s New Products Review Process
Concepts, practices and procedures of securities industry and banking compliance
Rules and regulations of FINRA, SEC, MSRB, CFTC, NFA, DOL, IRS, CFPB, Federal Reserve Board, OCC, Department of Treasury, FCA, IIROC and other foreign regulatory authorities, state securities regulators and state insurance regulators
Investment concepts, practices and procedures used in the securities, banking and finance business
Written and verbal communication skills sufficient to professionally address a wide and varied audience both internally and externally
Preparing oral and written reports
Ability to read, analyze and communicate complex issues
Operating standard office equipment and using required software applications, including database applications and regulatory agency systems
Team leadership and participation
Represent the firm at peer and industry events in a professional manner
Bachelor’s degree in a related discipline required, J.D. preferred
General knowledge of the securities industry and related business with a minimum of five (5) to seven (7) years of experience in the regulatory field

Country Regulatory Affairs Officer Resume Examples & Samples

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

Regulatory Affairs Officer Resume Examples & Samples

To ensure that the company's products comply with the regulations of the Medicines and Healthcare Regulatory Agency
To ensure the company's manufacturer and wholesale dealer licenses are maintained and up to date to allow importation and distribution of all company's products
To support the regulatory department for eCTD submissions, preparation of submissions of license variations and renewals to strict deadlines
Responding to questions from regulatory authorities raised during technical review of submissions, variations and renewals
Write and review all SOP's within the regulatory department
Staying updated with all European regulatory legislation, guidelines and customer practices

Regulatory Affairs Officer Resume Examples & Samples

Perform regulatory assessment of change control cases
Prepare regulatory strategies and participate in the preparation of the quality documentation to support clinical trial applications (INDs, IMPDs), new marketing authorisations (NDAs, MAAs) and variation applications in global markets
Plan and project-manage CMC related aspects regarding submissions
Work as part of a cross-functional team, which has the responsibility to create and maintain CMC documentation for drug substances and drug products
Participate in and provide regulatory support to project teams looking into development and life-cycle management of the products
Relevant scientific degree
2-3 years' experience from Regulatory Affairs within CMC development or life-cycle management
Knowledge of regulatory requirements in EU, US - preferably also in countries outside EU, e.g. Japan
Clear focus on agreed objectives, even when working with tight deadlines

Regulatory Affairs Officer Resume Examples & Samples

Ensure timely preparation and compilation of registration dossier for assigned projects in accordance to EU standards and corporate requirements
Manage international regulatory submissions according to company strategy and ensure meeting registration deadlines, via timely answering Health Authorities' queries and deficiencies as well as via close cooperation with other involved functions and liaison with Regulatory Authorities, in order to support the timely introduction of new product into markets
Maintain assigned products' Marketing Authorisations via timely variations and renewals submissions and their approvals
Build departmental awareness of local regulatory requirements in global markets
Compile regulatory component of annual product review and PSUR
Archive the registration documentation acc. to internal standards; introduce and regular up-dates to the internal RA database
Perform assigned tasks with the highest quality and in accordance to established internal timelines

Senior Regulatory Affairs Officer Resume Examples & Samples

Prepare written responses to inquiries received from regulatory entities, such as FINRA, SEC and state regulators. Gather accurate and detailed information necessary for those responses through research of associated accounts and securities, review of Firm policies and procedures, search of Firm records, and interaction with Firm employees. Ensure that responses meet required deadlines. (60%)
Assist, manage and facilitate examinations conducted of the Firm and branch offices by regulatory entities. Interact with Firm employees and departments, and gather Firm records to obtain documents and information responsive to examiner requests. (20%)
Maintain databases of Regulatory Affairs activities. Generate reports created from the database and distribute to effected compliance personnel and business units. Enter and update department-related information into Enterprise level regulatory risk reporting tool. (10%)
Identify trends and potential risks to the Firm in regulatory inquiries and examinations. Utilize expertise and knowledge to identify potential solutions related to those trends and risks. Facilitate the resolution of issues identified during regulatory inquiries or examinations that require corrective action. (10%)
5+ years of legal/regulatory or equivalent compliance experience
Series 7 and 24, or ability to obtain within 180 days of start date
Strong written and general communication skills
Strong organizational skills and the ability to prioritize workload
Experience in Microsoft Excel and Microsoft Access

Regulatory Affairs Officer Resume Examples & Samples

Assist in the design, implementation and supervision of a comprehensive compliance and surveillance program
Work with business unit leaders to develop, communicate and implement strategies, procedures and technology systems designed to enhance the firm’s compliance function
Oversee periodic compliance reviews and ongoing maintenance of documentation in support of corrective measures taken
Work with business unit leaders to evaluate and enhance IT processes and procedures that support compliance with Investment Adviser regulations
Work with business partners to ensure operating policies and procedures are in compliance with required regulations and assist in setting objectives to bring non-complying areas into compliance
Partner with senior business executives, legal, risk management, and compliance to appropriately mitigate and manage regulatory and litigation risk
Provide periodic summaries and reporting to RJF and subsidiaries/business units
Work closely with business units and Compliance to ensure that the rules repository used by the firm is complete and up to date
Research existing rules and monitor regulatory developments, communicating changes to affiliates and home office staff
Develop, implement, sustain, monitor and revise compliance programs that reflect “best practices” and ensure the firm is adhering to all legal and regulatory requirements
Ensure procedures are appropriately documented and referenced in the firm’s compliance manuals and standard operating procedures
Oversee testing, perform risk assessments, and verify internal controls are adequate to achieve compliance with prevailing rules and regulations
Support a culture of risk management and compliance throughout all levels within the firm
Respond to, oversee and/or assist, counsel with responses to regulatory inquiries
Develop policies and procedures and design processes to mitigate regulatory risks
Identify trends and implement corrective action as necessary
Plan, assign, monitor, review, evaluation and lead the work of others
Coach and mentor subordinates, identify training needs and recommend appropriate development programs

Senior Regulatory Affairs Officer Resume Examples & Samples

Be the primary RA representative for the Immunodiagostics products for which Dartford has responsibility as well as RA responsibility for distribution activities of other MBD products that are distributed from the Dartford site
Develop and deploy global regulatory strategies and manage the pre-market submission of the Immunodiagostics products as well as assist with the registration of Dartford-distributed products as necessary
Act as the lead RA within a cross-functional project team, providing inputs into New Product Development, changes to existing products and other activities involving the complete life-cycle management of products
Be responsible for the planning and implementation of new and updated regulations as applicable to Dartford products while working in coordination with global regulatory affairs
Assist Line Manager in gathering relevant KPI and metrics
Lead change projects and site quality review meetings
Bachelors or Masters degree in Science preferably in the Biological Sciences or Regulatory Affairs
Proven experience in regulatory affairs in IVD or medical devices companies. Regulatory Affairs Certified individual preferred
Ability to make balance decisions in relation to business/customer requirements and offer appropriate advice
Ability to work with minimal supervision with sound technical judgment and analytical skills in a highly matrixed business environment
Ability to coordinate and manage the completion of multiple projects simultaneously
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Multitasks, prioritizes and meets deadlines
Strong organizational and follow-up skills, as well as attention to detail
Ability to travel within UK and internationally as required
Proven experience in RA in IVD or medical devices companies
Experienced in 510(k) submission or Technical File compilation
Demonstrated experience in navigating complex pre-market submissions
Experience working in a broader enterprise/cross-division business unit model preferred
IND-EMEA

Regulatory Affairs Officer Healthcare Resume Examples & Samples

Accountable for worldwide product registrations
Responsible for reparation, conduct, and follow-up of submissions to international regulatory bodies
Communicate product registration status to different stakeholders
Manage product registration overview and maintain internal regulatory registration portal
Monitor product compliance, safety and performance after product release (post-market surveillance)
Handle and manage escalated customer complaints
Manage and respond to regulatory and environmental customer requests
Bachelor’s degree in a technical field or an equivalent combination of experience and education
Excellent verbal and written communication skills in both Dutch and English, with attention to details
Self-motivated and self-starting
High level of credibility and trustworthiness
Excellent team worker: demonstrate ability to motivate others, work as a team and take ownership where required
Experience with medical device requirements (MDD, FDA, Health Canada, …) or regulatory affairs is a plus
Minimal 3 years of experience in regulatory or similar function

Regulatory Affairs Officer Resume Examples & Samples

Acts as a Regulatory Team Leader on small, straightforward regulatory projects and/or becomes involved in a small single service project, under the guidance of senior staff
Understands the Scope of Work, deliverables and management of budget for any given project
May prepare slides and background material for small, straightforward business development meetings under senior guidance and present to clients at bid defence meetings by phone or in person
May prepare and deliver training, as appropriate
Performs other tasks or assignments, as delegated by Regulatory management

Regulatory Affairs Officer Resume Examples & Samples

Follow-up input request from HSA to ensure successful product registration
Submit change notification for registered products when there is an update of the dossier
Ensure local regulations are observed and implemented within the company
Coordinate with global regulatory and HSA for all regulatory related issues
Maintain the SMDR Listing for approved products
Maintain the registration status in GTS
Assist in the implementation of field safety corrective action (FSCA)
Assist in the reporting of FSCA and adverse events to HSA according to the required timeline
Assist in the training of the local personnel on complaint management requirements/procedures
Ensure that all incoming local customer complaints and inquiries are accurately entered in the complaint management system and up-to-date status
Update and issue complaints handling and quality related SOPs when required in accordance with the Roche Divisional Standard and HSA requirements
Assist in the preparation of the GDPMDS audit

Regulatory Affairs Officer Resume Examples & Samples

Bachelors Degree or Equivalent Experience; At least 5+ years of risk management, audit, legal, regulatory and/or quantitative experience
Advanced knowledge of applicable US laws and regulations and federal/state banking and securities industry regulators needed
Applicable college coursework could substitute for a portion of work experience
Demonstrated ability to develop and maintain close working relationships with internal and external stakeholders
Advanced PC (MSWord, Excel, Access, PowerPoint) skills
Strong knowledge of applicable US laws and regulations and financial services industry regulators, and understanding of banking operations and the financial services regulatory and risk management environment
Strong organizational skills, including ability to prioritize several projects at a time

Regulatory Affairs Officer Resume Examples & Samples

Obtain regulatory documents from International Regulatory and coordinate with our Business Partner to either Register our Products with National Competent Authority (NCAs) or to complete the Regulatory Documentation required for Tender Purposes or custom clearing (Business Critical)
On-Time Product Registration and Renewal of Registration with NCAs in MEA, in collaboration with Business Line Regulatory Officers and Business partners
Provide Regulatory Documents required for Custom Clearing or Tender Processing
Works closely with HC Business Areas & Business Lines in order to obatain relevant regulatory documents for registration (in-vivo & in-vitro)
Healthineers Product Portfolio and go-to-market set-up (Business Partners & Distributors)
Regulatory affairs and NCA requirements in the region i.e. SFDA or MOH UAE (in-vivo & in-vitro)
Bi-lingual (fluent in english & arabic, reading and writing)
3 to 5 years of relevant experience in the field of medical device regulatory affairs
Ability to work in various projects in-parallel and know basic project management skills (cross several time-zones)
Communication in a multi-cultural environment
Microsoft Outlook & Office skills mandatory
Systematic and good in time management

Regulatory Affairs Officer Resume Examples & Samples

Provides regulatory strategy of CMC submissions worldwide
Prepares and reviews CMC documentation required to support submissions e.g IMPD updates, MAA, post approval variations and renewals
Manage own work load, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate
Complete understanding of the content and typical level of detail in Module 3
Manage cross functional interactions with supervision to support CMC activities
Experience of product development/manufacturing or analytical work is strongly preferred
Experience of using document management and change control systems
Cultural awareness
Project management experience an advantage

Regulatory Affairs Officer Resume Examples & Samples

Working in compliance with relevant Working Instructions and SOPs - as well as current EU and national regulatory regulation
Close collaboration with RCC for planning of renewals / variations
Close collaboration with all in DRA Nordic, Nordic QA, SCM on variations / renewals
Keeping labeling managers and other relevant departments / colleagues updated on timelines for ongoing procedures
Prepare and ensure timely submissions of national texts for renewals / variations for Global products in the Nordic
Respond to requests from the authorities and deliver information/documentation about products/active substances in accordance with the deadlines given
Text management including preparation, proof reading and release for print in accordance with current regulatory Directives, Regulations and guidelines of SmPC, PIL and labeling
Regulatory handling of Change Controls / NCs
Coordinate Common Nordic Packaging materials – evaluate conditions and needs
Secure that MAs are withdrawn if requested by CommOps or RCC
Updating of relevant databases
Negotiation with regulatory authorities
Ensure a smooth and timely transfer of the responsibility from DRA launch team to LCM, Global products
Keeping updated on EU and national legislation in each of the Nordic countries with a special focus on Sweden
Master degree in Pharmacy or Life science
Nordic language and English
3 years of regulatory experience
Good knowledge of national and EU regulatory regulation

Regulatory Affairs Officer Resume Examples & Samples

Responsible for monitoring and ensuring timely response to all exam-related or other inquiries and requests from federal and state regulators
Collect and analyze data and information from Bank lines of business, as necessary to ensure appropriate responses
Work with MS Word, Excel, and PowerPoint to gather and process information from lines of business, provide to regulators and develop plans, reports, and presentations
Partner with stakeholders throughout the Bank to ensure accuracy and timeliness of information provided to regulators
Manage examination processes, including providing support to on-site exam teams as required
Keep abreast of legal and regulatory matters affecting the US bank regulatory environment
Implement standards and procedures as necessary
Maintain documentation and supporting work papers
Provide direct support for General Counsel and Associate General Counsel(s), as required
Bachelor’s Degree or Equivalent Experience: 5+ years of risk management, audit, legal, regulatory or exam management experience
JD helpful, but not required
Knowledge of applicable banking laws and regulations and federal/state banking industry regulators needed
Ability to develop and maintain close working relationships with internal and external stakeholders
Strong organizational skills, including ability to prioritize multiple simultaneous projects

Regulatory Affairs Officer Resume Examples & Samples

You will coordinate the registration of our portfolio of products (new launch or renewal of on the shelf products) via registration officers for our 14 offices around the world. In this coordination you will have some management tasks and we can support you in growing your managerial competencies if this is something you want to develop
This is the more die-hard regulatory part of the role. Your knowledge is what is truly needed here. You will translate Food Law from different countries and translate it to our different products to be compliant with the regulations per country. Also to help this process you will implement the regulatory and nutrition validation process
You will support our Medical Marketing teams in being compliant with the materials the produce (labeling, packaging design/ layout). Parts of that are checking but also empower them to take regulatory in their own hands by providing toolkits and training. You will provide regulatory risk assessment on all communication materials

Regulatory Affairs Officer Resume Examples & Samples

Completion of customer own format product questionnaires and related documents
Generation of standard regulatory documents and MSDS
Answering customer regulatory enquiries
Reviewing regulatory aspects of product revisions
Keeping up-to-date with relevant legislation
Liaising with local authorities, trade bodies and research organisations
Supporting sales with Regulatory training/ presentations and customer visits
Participation in site teams, e.g. internal audits, complaints management, food safety and EHS as required
Supporting site certification audits as required
Supporting corporate quality, environmental, food safety and health and safety objectives
Bachelor of Science in Chemistry/ Food Technology or its equivalent
Minimum 2 years of combined regulatory and technical experiences in food industry or related fields
Broad knowledge and understanding with food law is an advantage
Advanced knowledge in Microsoft Office and SAP
Excellent communication of English in both written and spoken
Ability to understand and interpret relevant rules and regulations
Strong team player with consistent track record
Self-motivated to meet deadlines

Regulatory Affairs Officer Resume Examples & Samples

The ideal candidate additionally should have more than two years of labelling expertise
Involvement in regulatory strategy and determination of documentation requirements, timelines, budgets
Minimum of 5 years in international regulatory lifecycle maintenance experience, focusing on marketed established products
Excellent verbal and written communication skills, proficient English skills are essential
Be able to manage own and peaks of workload

Senior Regulatory Affairs Officer Resume Examples & Samples

Minimum Requirements/Qualifications
Non-Negotiable Hiring Criteria
Experienced in submission or Technical File compilation
Strong project management and organisational skills

Senior Regulatory Affairs Officer Resume Examples & Samples

Conducts CMC change control assessments
Authors and reviews Module 3 sections
Manage own work load, tracks project timelines, implements client requests and manages day-to-day workload
Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters
Acts as mentor to junior colleagues
Minimum 5 years regulatory with at least 2 year focusing on CMC
Experience of small molecule and/or biological products
Knowledge of variations/renewals/procedures in Europe and/or emerging markets
Experience of conducting CMC Change Control Assessment – determine if regulatory action is required and if so determine the strategy, documentation requirements and timelines
Manage cross functional interactions to support CMC activities
Prepare and review Module 3 CTD sections for regulatory submissions (variations, renewals, responses to RA assessments)
Project Management of small to medium size projects
Be able to manage own workload
Ability to work to tight timelines

Regulatory Affairs Officer Resume Examples & Samples

Life Cycle Management of existing marketing authorizations (MA) in the Nordic countries in cooperation with headquarter or 3rd party manufacture
Identification and implementation of appropriate Nordic regulatory strategies - Expert on regulatory requirements in the Nordic countries
Contributes in obtaining good working relations with the Authorities in the Nordics
Is a resource of knowledge about national and EU legislation within the regulatory field - Expert on regulatory requirements in the Nordic Countries
Master degree in pharmacy or life science
Nordic languages (preferred mother’s tongue)
2-5 years of experience preferably within Regulatory Affairs
Good knowledge of national and EU regulatory legislation

Regulatory Affairs Officer Resume Examples & Samples

Be knowledgeable and display a good understanding of regulatory working practices for IVDs in particular higher risk (e.g. Annex II and PMA products)
Take responsibility and positively contribute as regulatory representative in different company forums within 3 months of start date
Plan, contribute, evaluate and deliver on the needs of various projects simultaneously where needed
Build respect and trust with customers, both internally and externally, to establish effective and influential working relations
Develop high level of personal quality and embrace right first time culture
Be open-minded; recognise and respect differing views from others
Actively contribute to continuous improvement opportunities ensuring compliance and best value can be achieved
Develop technical expertise in the field, specific product (processes) areas and keep abreast with own area of expertise
Ability to work independently and take accountability
Assessment of product risk complexities, product safety and effectiveness
Coordinates and facilitates submissions making best use of knowledge and expertise across departments and lessons learnt and communicate effectively with key stakeholders
Makes timely and sound decisions after appropriate evaluation of input or information
Educates and shares information and coaches others on regulatory expectations
Be open and contribute towards improvements / changing expectations
Strive for simple and effective solutions
Be supportive and self-reliant; be able to act and function independently whilst interacting effectively with others collaboratively
Be realistic on capacity; plan and deliver on promises
Support cross-training opportunities & skills
Analyse working practices and offer flexibility where needed to deliver
The individual will display a strong drive and commitment toward product safety and quality, and meeting customer expectations
The individual will be aware of expectations of them and display autonomy and accountability for their actions
They must be sufficiently open-minded to react to changes in workload as priorities may change
They should display an ability to communicate effectively to their audience both internally and externally including regulatory bodies
The individual should be self-motivated with the ability to deliver appropriate results, having good time management and facilitation skills
The individual should have experience of working practice within regulatory or quality areas
They should be knowledgeable about the requirements of at least one of the following areas, IVD Directive, FDA 510k submissions, cGMP requirements as they impact on RA but support to develop these will be provided
An awareness of current development and manufacturing processes, differing product complexities, risk classification and stability are also an advantage
Develop high level of personal quality and right first time culture
Act proactively to overcome regulatory challenges
Be resilient; recognise and deal appropriately where views may differ
Communicate ideas clearly and concisely (oral, written and presentations)
Display high level of personal quality and a right first time attitude
Ability to form close working relations to remain informed
Technically competent including higher risk products
Effectively review and analyse the work of others
Sound understanding and awareness of regulations and expectations globally
Awareness of development and manufacturing processes
Communicate in a clear and concise way that is relevant to your audience
Attend meetings and contribute positively
Train and support others as needed ensuring alignment and engagement
Act responsibly, calmly and ethically where views differ to reach agreement
Contribute towards improving work practices to deliver above expected level
Cross reference against regulatory strategic plan

Principle Regulatory Affairs Officer Resume Examples & Samples

Keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to
Collecting, collating and evaluating scientific data that has been researched by colleagues
Developing and writing clear arguments and explanations for new product licences and licence renewals
Preparing submissions of licence variations and renewals to strict deadlines
Monitoring and setting timelines for licence variations and renewal approvals
Working with specialist computer software and resources
Writing clear, accessible product labels and patient information leaflets
Advising scientists and manufacturers on regulatory requirements
Project managing teams of colleagues involved with the development of new products
Undertaking and preparing for regulatory inspections
Reviewing company practices and providing advice on changes to systems
Liaising with, and making presentations to, regulatory authorities
Negotiating with regulatory authorities for marketing authorisation
Specifying storage, labelling and packaging requirements
Problem solving skills, understand technical data
Demonstrated management of direct reports
Proven submission track record to competent agencies (MHRA/HPRA)
Experience of UK/ IE Affiliate RA knowledge (at least 5 years),
Educated to degree in life science discipline,
Work across multi-disciplinary teams/ departments (e.g. of collaboration)
Ability to work under pressure, deliver on time
Integrity and professional work ethic
Member of TOPRA and other recognised technical professional bodies
Considerable understanding of legal and scientific matters

Regulatory Affairs Officer Resume Examples & Samples

Bachelor degree required in a technical discipline
Minimum of 5 years of experience in the medical device industry (CFDA, EU MDD, US FDA class II or class III, etc.)
Proficient knowledge of medical device regulations minimum CFDA, FDA, EU. Worldwide is desired. Must have personal experience with clinical trials and CFDA submissions
Proficient knowledge of domestic and international standards
Experience in supporting international registrations and/or clinical investigations

Senior Regulatory Affairs Officer Resume Examples & Samples

Obtain and maintain all necessary licences (Marketing Authorisations (MA’s), Clinical Trial Authorisations (CTA's) Etc.) for a designated list of products
Maintain an awareness of current Irish & EU regulatory requirements
Deputise in the absence of the Head of Regulatory Affairs.Submit applications (new MA's/Clinical Trials/Variations/Renewals etc.) for National/EU MA 'sand negotiates with the Health Products Regulatory Authority (HPRA) to resolve any issues to minimise the delay in approval
Ensure prompt resolution of regulatory issues affecting the Irish business
Communicate significant regulator issues/developments to commercial and the potential impact on the AbbVie Ireland business
Liaise with AbbVie UK, European and Global groups on regulatory issues as relevant
Liaise and attend meetings with other company functions to provide regulatory advice for new products, indications, promotional campaigns etc
Review of product information and promotional material prior to re lease
Cover all Regulatory aspects of pharmacovigilance
Maintain compliance of regulatory based labelling (Summary of Product Characteristics (SPC), Package Leaflet (PL) and Prescribing Information (PI))
Maintenance and update of all internal required reporting activities and databases (AbbVie Connect, Launch Excellence, Monthly Report etc.)
Maintain awareness of current and new legislation/ guidance and ensure that work is in compliance with the requirements
Develop and maintain regulatory Standard Operating Procedures (SOP's) as required and provision of regulatory support during inspections and audits.Strategic Input & Regulatory Intelligence
Provide strategic regulatory input and support to the AbbVie Ireland business
Build relationships with the HPRA, Irish Pharmaceutical Healthcare Association (IPHA) and other relevant organisations and personnel both internally and externally
Gain regulatory approvals by appropriate negotiation with the HPRA and/or EU and Global groups
Anticipate and monitor changes in National and EU regulatory requirements in order to contribute effectively to product development and regulatory strategies
Monitor the regulatory landscape for generic, parallel import and competitor activity as relevant
A Third level degree qualification in Life Science or similiar
4 years's plus experience of working in a regulatory position is ideal
Knowledge and experience of GDP and GCP regulatory environments would be beneficial
Strong negotiation, influencing, presentation skills
Strong visionary, strategic, tactical and motivational skills

Regulatory Affairs Officer Resume Examples & Samples

Good, solid interpersonal communication (oral and written) and organisation skills
Ability to work on several projects, with direction from senior staff as appropriate
Ability to make decisions on discrete tasks under senior supervision
Ability to establish and maintain effective working relationships with co-workers, managers and clients

Senior Regulatory Affairs Officer Resume Examples & Samples

Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate
Competently writes regulatory and/or technical documents with minimal review by senior staff
Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues
Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate
May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development
May present to clients at bid defence meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff
May write new regulatory SOPs, and/or propose revisions and/or act as reviewer for regulatory SOPs, as assigned and appropriate
May be involved in a Regulatory and/or Quintiles Initiative
Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
Demonstrated skills in chairing small meetings
Ability to work on several projects, retaining quality and timelines and can prioritise workload with minimal supervision
Ability to propose revisions to SOPs or suggest process improvements for consideration

Regulatory Affairs Officer Resume Examples & Samples

Understands portfolio and is aware of the business potential in the country. Ensure constant supply of the Novartis portfolio
Effectively recommends and implements regulatory strategy
Builds and maintains excellent relationship with competent regulatory authorities
Supports global regulatory functions for applications filed under the EU systems, namely Mutual Recognition and Centralized Procedures
Provides support to other international projects as required
Performs all submissions and approvals for medicinal products and clinical trials according to the timetable given by the HQ and according to the CPO plan. Maintains full responsibility of all regulatory activities on assigned projects and prioritizes activities to ensure completion of goals. Works to minimize regulatory issues and helps prevent unnecessary delays
Supports the registration activities related to product launches
Supports regulatory support key to meeting launch plans and maximizing product claims as well as advocacy activities as required
Manages all regulatory translation activities as required
Ensures smooth production transfers and variations resulting in business continuity
Manages the discontinuation of Product Licenses for allocated products that are to be pruned
Provides Basic Succinct Statements to be used in promotional materials/RMP educational materials as required
Supports local RA Head in monitoring the whole regulatory approval process identifying critical steps and suggesting optimization actions
Responds to technical and scientific HA questions. Coordinates, timely submissions and follows-up response documents to HA requests
Timely submits PSURs, DSURs and RMPs as necessary
Maintenance of existing Product Licenses
Where applicable organizes and participates in Health Authority scientific advice and pre-submission meetings, and other clarification meetings with global teams to support product development programs

Regulatory Affairs Officer Resume Examples & Samples

Life Cycle Management on MAs in the Nordic countries in cooperation with RCC-EU
Identification and implementation of appropriate Nordic regulatory strategies
Expert on regulatory requirements in the Nordic countries
The open position is located in the Global RA Life Cycle Management team covering a portfolio that consist of marketing authorizations maintained within Sandoz. The life cycle activities relates to marketing authorisations (MRP/DCP and CP) in the Nordic countries
Maintenance and ensuring regulatory compliance of marketing authorizations in the Nordic countries
Cross functional planning and corporation with Regulatory Competence Center (RCC-EU), QA, Supply Chain as well as with 3rd party manufactures on variations and renewals
Prepare and ensure timely submission of national texts and mock-ups for Global products in the Nordics
Respond to request from the authorities within given deadline
Text management of national text including preparation and release for print
Updating of relevant databases (SAP and Access)
Regulatory assessment of change control cases in TrackWise
Knowledge about national and EU legislation within the regulatory field
Ensure compliance with regulatory guidelines
You are graduated with excellent results B.Sc. in Pharmacy or have a M.Sc. degree in life science combined with 3-5 years of professional experience within regulatory affairs
You have an knowledge of both the Nordic and European regulatory requirements and have the ability to interpret and apply regulations appropriately
You are energetic, passionate and enthusiastic and thrive in a fast-paced environment and are able to meet timelines reliably and without undermining quality along with working effectively and collaboratively across the organization
You are self-confident, a strong and pro-active team player, but are also able to work independently to plan, structure and coordinate your tasks
You are a fast learner and is able to handle multiple tasks at the same time. -
Furthermore, you demonstrate excellent communication skills – both written and verbal – and are fluent in at least one of the Nordic languages (preferred mother’s tongue) as well as English. Languages skills within other Nordic country languages are an advantage

Regulatory Affairs Officer Resume Examples & Samples

A Pharmacist’s Degree required
Requires a minimum of 1 years of progressively responsible, relevant experience from working in Regulatory Affairs
High commitment to quality of all projects. A “do what it takes” mindset and positive attitude
IT systems competencies is a plus
Keen attention to detail and skill in reviewing to ensure accuracy
The ability to manage multiple projects simultaneously
The ability to work effectively and efficiently under deadlines
Good knowledge of local legislation
Fluency in written and spoken Arabic, French and English is a must

Regulatory Affairs Officer Resume Examples & Samples

Responsible for preparation, conduct, and follow-up of submissions to international regulatory bodies
Keep worldwide product registration knowledge up to date and adapt processes accordingly
Monitors product compliance, safety and performance after product release (post-market surveillance)
Handle and manages customer complaints
Manage and respond to customers regulatory and environmental requests
You have a bachelor’s degree in a technical field or an equivalent combination of experience and education
You possess excellent verbal and written communication skills in both Dutch and English, with attention to details
You act self-motivated and self-starting
You have a High level of credibility and trustworthiness
You are an excellent team worker: demonstrated ability to motivate others, work as a team and take ownership where required
You are interested to investigate medical device regulations
Experience with medical device requirements(MDD, FDA, Health Canada, …) or regulatory affairs
Experience with clinical trials follow-up is a plus

Regulatory Affairs Officer Resume Examples & Samples

Assist the Head of Regulatory Affairs with administrative support including diary, travel, invoices and expenses management 
Assist in preparation of applications to applicable regulatory agencies within the agreed timeframes; 
Prepare and file regulatory correspondence and documentation inclusive of scanning documentation; 
Compile correspondence and documentation, and scanning of documentation as needed; 
Maintain TGA Import/Export Licenses and obtain import permits for products as necessary to ensure compliance for entire product portfolio; 
Obtain AQIS permits as required; 
Coordinate maintenance of various third-party electronic databases, e.g. eMIMS 
Coordinate maintenance of various (internal) regulatory databases, 
Support and facilitate timely and compliant Pharmacovigilance outcomes within agreed timeframes e.g. PV reports, PSURs, CDSs 
Support SOPs and WIs creation and maintenance as required by the department; 
Obtaining department administrative supplies including product samples to ensure timely submissions can be achieved 
Ensuring timely processing and payment of invoices for Regulatory Affairs and Business development teams 
Reconciliation of department credit card statements for the Regulatory Affairs

Senior Regulatory Affairs Officer Resume Examples & Samples

Dispatch in a timely manner the relevant regulatory documentation to distributors and/ or MAHs for registrations and/or submit to the Health Authorities, as applicable
Communicate submission dates and approval dates to stakeholders, as applicable
Responsible for the overall coordination and dispatch/submission of responses to distributors/ MAH or directly to Health authorities, as applicable
Responsible for preparing answers for simple questions not requiring product expertize or input from other internal stakeholders
Coordinate and participate at Scientific Advice Meetings, as applicable

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