Associate, Regulatory Affairs Resume Sample
Madaline Roob
78237 Rodriguez Pike,
Phoenix,
AZ
+1 (555) 262 7997
Work Experience
Senior Associate Regulatory Affairs
10/2017
-
PRESENT
Chicago, IL
- The company operates in a highly regulated business environment. Many of the products in the OTC portfolio are approved under an NDA (New Drug Application) and some contain active ingredients also marketed as prescription drugs
- , to work together with logistic colleagues to prepare products registration plan to make sure there is no out of stock situation happened
- , to guide RA specialist to do routine RA work in plant
- , to participate RA related organization to share Merck RA voice in these organizations
- , to support head of regulatory department in some RA related activities in the company
- Support regulatory affairs activities related to Canada’s Chemical Management Plan
- Raise concerns with the Functional Lead as appropriate
Senior Associate, Regulatory Affairs
08/2014
-
07/2017
Dallas, TX
- Develops and ensures the successful adoption and execution of appropriate regulatory strategies and processes, which ensure project and/or product programs meet established timelines and are aligned with Astellas' short and long-term business strategies and goals
- Collaborates with GRA management to provides oversight on regulatory matters; and where needed, directs the contributions to meetings with regulatory authorities, key opinion leaders and similar experts and bodies
- Provides regulatory expertise for planning, approving regulatory content and reviews/participates in the evaluation of in-licensing opportunities and due diligence activities
- Monitors regulatory developments, guidelines, and industry trends, particularly with respect to assigned projects/products, and prepares recommendations and robust opinions for management in a timely manner
- Interprets, identifies, recommends, and advises project/program teams and Company on regulatory guidelines and risk matters and is accountable for the development and implementation of plans to address regulatory and/or product issues
- Provides regulatory advice to ad hoc teams/task forces set up for process improvements, alignment with new regulatory requirements or business initiatives on behalf of GRA
- Contributes to the strategy for interaction with Health Authorities or business partners for the assigned projects/products. Builds and maintains good relationships with Regulatory Authorities
- Assure regulatory compliance with regard to assigned, approved and/or marketed medicinal products and medical devices
Associate, Regulatory Affairs
11/2009
-
05/2014
Detroit, MI
- Build and maintain good relationship with National Competent Authorities (NCA
- Utilizes multiple regulatory databases to ensure the stringent accuracy and compliance of label data for assigned products, including: Nutrition Facts, Ingredients, Allergy disclaimers, Dietary/health claims, etc.
- Participates on project teams or sub-teams for the planning of activities needed to meet development program objectives. This includes preparing and managing timelines for all regulatory submissions such as initial INDs, IND amendments, CTx, NDAs, meeting requests, briefing books, etc.
- Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines
- Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review
- Identify and interpret domestic and international applicable laws, regulations and related performance standards that apply to chemicals, their use in Company’s products, and their distribution, and help develop, and implement processes and procedures to facilitate and promote global compliance
- Prepare regulatory submissions to various health authorities in compliance with appropriate company business processes and external regulations/guidance/specifications
- Publish (e.g. convert to PDF, bookmark, hyperlink) individual regulatory documents as needed
- Remain current on internal/external electronic submission initiatives and requirements
Education
Grand View University
2003 - 2008
Bachelor's Degree in Life Sciences
Professional Skills
- Computer literate; effectively utilize web-based and internal databases and systems such as SAP PLM, third-party electronic regulatory data sources such as ChemAdvisor’s LOLI, and Microsoft Office software
- Excellent word-processing skills and spreadsheet application skills
- Organizational skills & developing regulatory project management skills
- Strong time management skills, ability to plan and organize workload in order to meet deadlines
- Good interpersonal skills and the ability to deal effectively with a variety of personnel
- Prior experience working on submissions to the government would be an asset
- Technical system skills (e.g. word processing, spreadsheets, databases,online research)
How to write Associate, Regulatory Affairs Resume
Associate, Regulatory Affairs role is responsible for software, regulatory, sap, word, training, integration, database, procurement, compensation, oncology.
To write great resume for associate, regulatory affairs job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Associate, Regulatory Affairs Resume
The section contact information is important in your associate, regulatory affairs resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Associate, Regulatory Affairs Resume
The section work experience is an essential part of your associate, regulatory affairs resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous associate, regulatory affairs responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular associate, regulatory affairs position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Associate, Regulatory Affairs resume experience can include:
- Experience in/knowledge of developing and maintaining CTA documentation in the EU (e.g. IMPDs, IMPD amendments) and ability to work with some autonomy
- Relevant experience in regulatory setting with dietary, supplement, food, or OTC products
- Experience multi-tasking in a deadline controlled and highly regulated environment
- Two years of relevant experience in a regulatory setting with dietary, supplement, food, or OTC products
- Results driven with experience multi-tasking in a deadline controlled and highly regulated environment
- Closely cooperate with the assigned regulatory strategist and the product team
Education on an Associate, Regulatory Affairs Resume
Make sure to make education a priority on your associate, regulatory affairs resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your associate, regulatory affairs experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Associate, Regulatory Affairs Resume
When listing skills on your associate, regulatory affairs resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical associate, regulatory affairs skills:
- Demonstrated ability to communicate effectively, orally and in writing, with internal and external contacts
- Good collaboration skills and ability to work as part of a team
- Resilience, good interpersonal skills
- Technical systems skills (e.g. word processing, spreadsheets, databases, online research)
- Team and customer orientation with ability to communicate effectively in English both verbally and in writing
- Prioritize key business objectives and respond quickly to changing priorities
List of Typical Experience For an Associate, Regulatory Affairs Resume
1
Experience For Senior Associate Regulatory Affairs Resume
- Experience in chemical hazard communication regulations including SDS and label review
- Drugs/biologics/devices and manufacturing experience, pharmaceutical or health care background
- Strong technical knowledge of pharmaceutical manufacturing, quality assurance, GMP, ISO, ICH Guidelines
- Experience in regulatory affairs, preferably with a focus on electronic submissions
- Experience gained within a biologics organisation
- Demonstrate some cross-cultural and cross-functional awareness
- Biosimilars experience would be an advantage but is not essential
- Experience in review of promotional and non-promotional material in accordance with the UK and Irish industry codes of practice
2
Experience For Senior Associate, Regulatory Affairs Resume
- Quality Assurance, or Analytical development experience
- CMC-specific regulatory knowledge & experience
- Experience in Regulatory Affairs
- Previous experience with post-approval applications and RAC certification is desired
- Demonstrated ability to work independently to prepare submissions and ensure compliance with post-approval regulatory requirements
- Relevant industry experience and a BA or BS
3
Experience For Associate Regulatory Affairs Resume
- Experience in regulatory affairs or quality
- Health Canada submission experience (includes NDS, SNDs, NC, DINA, CTA, Medical Device submissions (Class II-III)
- Excellent pension policy
- Advising the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
- Marketing material review
- Planning and management of variation applications for assigned products
- Collaborate with external partners to communicate PDF publishing requirements and to remediate issues, if applicable
4
Experience For Associate Regulatory Affairs Director Resume
- Respond to general internal and external inquiries including operational queries from agencies
- Support archiving of regulatory files
- Company own saving scheme arrangement
- Assists in the creation and revision of Standard Operating Procedures as necessary
- Assist in development and improving processes related to regulatory submissions
- Identify and implement enhancements in business processes with other departments to ensure all eCTD submissions meet health authority requirements
- Routinely assess the department’s electronic submission capabilities and processes and provide feedback to Regulatory management in order to improve efficiency
- Coordinate with Drug Safety on the preparation and submission of Periodic Adverse Event Reports (PADERS) and PADER Waivers, as applicable
- Interact with Regulatory colleagues at remote sites to assist with workloads and/or to troubleshoot Operations-related issues
5
Experience For Associate, Regulatory Affairs Operations Resume
- Interface with external partners to obtain submission-compliant bioequivalence/clinical study documentation (Module 2 and Module 5)
- Maintain Regulatory Affairs databases with current product information (applications, submissions, Deficiency letters, etc.) and run reports (i.e. quarterly reports)
- Archive and maintain regulatory documentation (paper or electronic) in accordance with applicable regulatory requirements and the Company’s established practices and procedures
- Train colleagues on business processes involving Module 5 document processing for BE studies
- Assist in the development of training materials for internal personnel on regulatory operations topics
- Review FDA Regulatory Guidance related to electronic submission format and compliance to ensure ongoing compliance with eCTD requirements
- Train colleagues on eCTD requirements and related software
- Provide regulatory support for pre- and post-approval submission and address all electronic and software related issues
6
Experience For Senior Associate, Regulatory Affairs Strategy Resume
- Act as regulatory liaison with all departments within the company
- Provide operational support for regulatory submissions and activities in a timely and accurate manner in US and ex-US countries. This includes
- Prepare/support regulatory documents and registration dossiers for assigned marketed products (e.g. sNDAs, annual reports, responses to authority requests and any other regulatory submission) to agencies (FDA and other)
- Review regulatory documents and registration dossiers
- Monitor and track submissions and deadlines
- Support organisation of agency meetings
- Act as primary contact for DSI affiliates and license partners for queries, requests, coordination and tracking of dossier preparation and regulatory submissions (incl. timelines) for assigned products
7
Experience For Operations Associate, Regulatory Affairs Resume
- Collaborate with other functions within DSI, DSE and DS Japan, e. g. Production, Quality Control, Clinical Safety and Pharmacovigilance, Marketing, Medical, Clinical Operations, with DSI affiliates and external partners in order to maintain existing marketing authorisations and support for new product registrations
- Initiate and/or coordinate the preparation of packaging materials, including QC check of specific packaging material and monitoring of implementation of new packaging material
- Manage entries to internal and external databases, registries and listings, maintain team sites on collaboration platforms (e.g. SharePoint) by providing up-to-date regulatory information and documents in a timely manner
- Support budget preparation, invoicing, accounting and procurement processes and provide general administrative support when required
- Review items which are new to Medline to identify product regulatory requirements (including storage and handling requirements, Rx drug traceability requirements and item classifications)
- Enter required product information into SAP
- Monitor and release product from regulatory hold and verify the accuracy and authenticity of the information and documents
- Coordinate with IS on the Rx drug traceability process and with Item Master Data on the new item set-up process
- Maintain department databases, logs and files as required
8
Experience For Senior Associate Regulatory Affairs Submission Management Resume
- Plans and organizes regulatory documentation for device products. Prepares regulatory submissions (510(k), EU technical files) in line with local regulatory requirements and guidelines
- Routine responsibilities include providing Regulatory operational support for currently marketed products, which includes the review and approval of product/process related Change Controls, Design History Files, Labeling and Promotional/Advertising Materials
- Maintain annual product registrations and GUDID database
- Lead developing local regulatory strategies and plan for major submissions to register New Chemical Entities (NCE) or new indications with Director of Regulatory Affairs and agree local submission timelines
- Lead determining local Regulatory Risk for submissions and risk mitigation strategies where relevant
9
Experience For Senior Associate Regulatory Affairs CMC Resume
- Ensure Japan submission requirements are communicated to relevant regional and global regulatory team
- Commit / coordinate special project assignments as determined by the Director of Regulatory Affairs
- Collaborate with Clinical Study Teams, Local Amgen Offices and CRO partners to facilitate site/study initiation
- Provide EU regulatory input to the Global Regulatory Team (GRT) and advise early product teams on regulatory strategy with support from supervisor
- Knowledge and awareness of the relevant regulatory guidelines and legislation
- Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate to produce consistent results
- Planning and/or management of major submissions to register new product and/or new indication to existing products within an assigned product portfolio
- Ensures compliance of regulatory processes and prepares for full Regulatory Affairs Systems Audits, accountable for any subsequent action plans
- Competently manages meetings/expectations with Regulatory Agencies and/or groups within Quintiles
10
Experience For Associate Regulatory Affairs Director CMC Resume
- Ensure regulatory submissions are made on time and meet Amgen’s corporate and Swiss regulatory requirements
- Participate in local regulatory process improvements initiatives
- Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner
- Coordinate translation for local regulatory submissions
- Review promotional & non-promotional review
- Responsibility for all regulatory activities for products in assigned portfolio in compliance with local and global procedures
- Provide advice to stakeholders on potential areas of regulatory concern and new regulatory developments
List of Typical Skills For an Associate, Regulatory Affairs Resume
1
Skills For Senior Associate Regulatory Affairs Resume
- Teamwork skills and customer focus (both internal and external customers)
- Exceptional interpersonal skills; professional demeanor and attitude
- Experience in developing and maintaining MAAs, post-approval variation submissions, renewals, scientific advice meeting materials
- Experience in developing and maintaining CTA documentation in non-EU regions
- Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing
- Experience in actively participating in a Due Diligence evaluation
- Solid understanding of the Drug Development process
- Experience with and knowledge of Small Molecule Development (Phase 1 through NDA and post-approval), including CMC, Nonclinical, and Clinical Research
- Experience with drug distribution documentation and tracking
2
Skills For Senior Associate, Regulatory Affairs Resume
- Demonstrated ability to coordinate and synchronize multiple projects while maintaining accuracy, consistency, and quality
- Experience registering prescription pharmaceuticals, and ideally a background in biological medicines
- Experience within an affiliate pharmaceutical company and/or in-licensing pharmaceutical company
- Regulatory experience within the Biotechnology and/or Pharmaceutical industry
- Previous experience from MedTech or Pharma
- Previous experience from a similar position
- Acting as back-up for contact, drafting cover letters and assisting in the preparation for meetings with RA
- Drafting and reviewing document content (depending on level of regulatory knowledge / expertise)
3
Skills For Associate Regulatory Affairs Resume
- Reviewing improving and approving clinical trial supply plans
- Coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies
- Cutting-edge regulatory knowledge including CMC, non-clinical and clinical development
- Documenting CMC submissions and related communications in IMR; archiving documents in document management systems
- Developing an understanding of the regional regulatory environment, competitor intelligence and therapeutic area
- Advising the team on team submission strategies in preparation of CTAs and ensuring completion of submission packages within agreed timelines
4
Skills For Associate Regulatory Affairs Director Resume
- Understanding of regulatory processes. Ability to plan, coordinate and lead activities simultaneously on multiple projects
- Training staff on select CMC procedures and systems
- Interfacing with regulatory operations staff
- Providing input to documentation to ensure they accurately answer posted questions
- Reviewing protocols and ensure alignment with regulatory requirements
- Assisting with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities
- Assisting with submission and acceptance of MAA
- Ensuring country-specific submission packages are made available to the LOCs in accordance with agreed plans
5
Skills For Associate, Regulatory Affairs Operations Resume
- Working knowledge of Canadian Food and Drugs Act and Regulations and Medical Device Regulations as well as Health Canada policies and guidelines
- Fluent in English, listening and reading comprehension, speaking and writing
- Continuous learning and problem-solving capabilities related to word-processing file conversions
- Ensures robust investigation into customer complaints, including root cause determination, and timely closure and reporting
- Review and approve promotional material, labeling graphics and manage change control for product labeling
- Evaluates manufacturing and labeling changes, and promotional materials for regulatory impact with guidance
- Self-motivated, and capable of working independently with minimal supervision
6
Skills For Senior Associate, Regulatory Affairs Strategy Resume
- 2) Prepare, review, and approve labeling and SOP's
- Ensure all regulatory tracking systems are up to date
- Manage multiple projects and work in a fast paced, changing environment
- Subject Matter Expert in pharmaceutical product labelling
- Contributions to the design and content development of department training programs
- Provide audit support during regulatory inspections, both domestic and international
- Lead major submissions to register NCEs or new indications for existing products when needed
- Help manage interactions with PMDA and MHLW and maintain a productive working relationship
- Provide technical support for the creation review and finalisation of components of CTA and/or Marketing Applications as well as routine regulatory submissions
7
Skills For Operations Associate, Regulatory Affairs Resume
- Manage IMPD submission and amendments in accordance with global and European filing plans and timelines
- Collaborate with EU Commercial Team to support ongoing commercial activities for the product as delegated by the EURL and under supervision of the EURL
- Maintains an awareness of new and developing legislation, regulatory policy and technical
- Contribute to and execute the filing plan for Switzerland
- Review source and artwork text for country labeling
- Maintain an awareness of and ensure local management are kept up to date on new and developing local legislation and regulatory policy
- Prepare, review, and approve labeling and SOP's
8
Skills For Senior Associate Regulatory Affairs Submission Management Resume
- Support regulatory activities relating to specific portfolio of products/projects (product owner)
- Maintain and update existing regulatory authorizations
- Program management and meeting coordination for
- Contribute to and execute the filing plan for their country where applicable
- Maintain an awareness of & ensure local management are kept up to date on new & developing local legislation & regulatory policy
- Utilize InSight Manager for Registrations (IMR); archiving documents in document management systems
- Contribute to the design and content development of department training programs
9
Skills For Senior Associate Regulatory Affairs CMC Resume
- With oversight, serves as a liaison with regulatory agencies pertaining to assigned products/teams
- Assists in the preparation of agency meeting packages and strategies for agency meetings
- Exceptional knowledge of US Regulatory requirements
- Knowledge about global regulatory trend, mainly US and EMA
- 3) Participate as an active team member and provide regulatory advice to project teams as required
10
Skills For Associate Regulatory Affairs Director CMC Resume
- Analysis: Recommend packaging components for elimination based on the SCJ RUM List, assist in the creation and/or continuous improvement of Global Environmental Safety’s processes and procedures
- Publish paper regulatory submissions, as needed
- Delivery of high-quality and compliant submissions to FDA
- Ensure regulatory documentation systems fulfill functional excellence and QMS goals
- Proficiency in basic regulatory principles
List of Typical Responsibilities For an Associate, Regulatory Affairs Resume
1
Responsibilities For Senior Associate Regulatory Affairs Resume
- Strong team player; excellent interpersonal, written and verbal communication skills
- Demonstrate strong problem-solving abilities and attention to detail
- Demonstrate thought leadership, work independently and progress multiple projects concurrently
- Experience with a consumer products company in a corporate compliance function is desired
- 2–3 years’ experience in pharmaceuticals required
- Experience working in a global, international regulatory environment
2
Responsibilities For Senior Associate, Regulatory Affairs Resume
- Data administration or management experience
- Advanced skill level in SAP and AS400
- Advanced skill level in Excel, Word
- Experience with Food GMP’s, SOP’s, HACCP/Food Safety and Environmental guidelines
- Inspiring and dynamic work climate in a global organization
- Understanding and application of principles, concepts, theories and standards of scientific/technical field
3
Responsibilities For Associate Regulatory Affairs Resume
- Prescription texts and labeling documents
- Support the commercialisation of products through participation in local brand teams
- Maintain excellent cross-functional relationships with key local, regional and/or global personnel in order to achieve goals and provide advice on the Australian, and when necessary New Zealand, requirements relevant to the development of international regulatory filings
- Provide comment on TGA/Medsafe consultation documents as required
- Expertise in AU and NZ prescription regulatory affairs environment, as well as GMP principles and procedures
- Participate as an active team member and provide regulatory advice to project teams as required
- Develop regulatory project plans
- Represent or lead Regulatory Affairs in small project teams
- Knowledge of hardware and/or software helpful
4
Responsibilities For Associate Regulatory Affairs Director Resume
- Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements
- Review promotion and non-promotion materials
- Disseminate relevant information to team(s) as appropriate
- Assist locally in Healthcare Compliance activities where applicable
- Collate, distribute, exchange and archive regulatory information with regulatory colleagues and cross functional teams and provide advice on local regulatory considerations in a timely manner
5
Responsibilities For Associate, Regulatory Affairs Operations Resume
- Product lifecycle maintenance devices and drugs
- Support in new product launches
- Support in business critical process e.g. tenders, country business projects
- B Sc in Life Science (Pharmacy, Chemical, Medical or similar)
- Native Norwegian or Danish speaker and fluent in English
- Works with line-Manager to plan, conduct, and manage regulatory activities to meet department and company objectives
- Independently develops knowledge of current regulations for assigned area of responsibility
- Ensures compliance with regulatory agency requirements and interpretations
6
Responsibilities For Senior Associate, Regulatory Affairs Strategy Resume
- Updates relevant local databases to ensure compliance
- Prepares and compiles regulatory submissions, responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines
- Supports the development, translation (if relevant), review and approval of artwork and promotional copy material to ensure regulatory compliance
- Supports the development of timelines for submissions and monitors progress of applications against set timelines, taking action where necessary to minimize delays
- Communicates information and presents status updates on product/project activities to key internal/external stakeholders
- Assists in development of best practices for Regulatory Affairs processes
- Provides technical guidance and input to complex problems in which data analysis requires an evaluation of intangible variables
7
Responsibilities For Operations Associate, Regulatory Affairs Resume
- Ensures quality and compliance in all actions
- Support regulatory activities associated with new and existing products in a variety of categories such as preparing labeling documentation, coordinating and reviewing labeling and advertising copy and labeling changes control
- Support efforts with regard to implementing the new federal labeling rule including creating presentations, maintaining spreadsheets and organizing materials for the Senior Associate Director
- Support team members by helping with new and existing products responsibilities
- Prepare and approve labeling graphics
- Prepare, review and manage change control for product labeling
- Review and approve promotional material
- Review new legislation and prepare detailed summaries on its impact to the organization
8
Responsibilities For Senior Associate Regulatory Affairs Submission Management Resume
- Review new legislation and prepare detailed summaries on its impact
- Support efforts to implement the new federal labeling rule including creating presentations, maintaining spreadsheets and organizing materials for the Senior Associate Director
- Review new legislation and prepare detailed summaries on its impact to the business
- Contribute to the organization and preparation of CMC investigational product amendments and post-market supplements, organization and preparation CMC sections of IND annual reports and annual reports of minor changes for specific products to meet the strategy defined by the global CMC team
- Document CMC submissions and related communications in InSight Manager for Registrations
- Initiate and maintain CMC product timelines at the direction of product lead
- Process regulatory assessments of change control requests
9
Responsibilities For Senior Associate Regulatory Affairs CMC Resume
- Train staff on select CMC procedures and systems
- Interface with regulatory operations staff
- Contribute to CMC product teams: interacts with authors/reviewers with respect to delivery of documents required for regulatory submissions
- Provide report status of activities and projects to teams and department
- Participate in cross-functional special project teams
- Provides regulatory advice and support to assigned products/teams
- Identifies and communicates registration needs and strategies
- Maintains awareness of applicable regulations
- Plans and organizes registration packages
10
Responsibilities For Associate Regulatory Affairs Director CMC Resume
- Prepares registration packages in line with local regulatory requirements and guidelines
- Accurately describes these changes for ease of regulatory agency review
- Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions
- Work independently with minimal daily instruction
- Supports Regulatory Affairs processes and deliverables in the local office
- Assist Regional Regulatory Lead (RRL) to support US Regional Regulatory Activities (e.g. IND development and submission, advisory committee meeting preparations)
- Create and maintain product regulatory history documents through Insight Management for Regulations (IMR) and appropriately archive all regulatory documents and agency communications
- Review regional component of the Global Regulatory Plan and provide input to operational deliverables; perform regulatory research to support the development of content for Global or Regional regulatory plan as delegated by the Global or Regional regulatory lead
- Actively support regulatory compliance and ensure compliance of submissions to regulatory agencies
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