Senior Regulatory Affairs Resume Sample
Jewel Muller
90223 Terry Falls,
Houston,
TX
+1 (555) 109 0714
Work Experience
Senior Regulatory Affairs Program Lead
09/2016
-
PRESENT
Detroit, MI
- Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels
- Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with regulatory agencies, industry groups, standards committees, political/government agencies, in order to influence external stakeholders and promote Regulatory perspectives
- Lead by leveraging diverse perspectives and backgrounds to generate effective ideas or solutions
- Deliver by acting with speed, flexibility , accountability and appropriately managing priorities to deliver results for on-time clearances
- Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with local and/or regional regulatory agencies, industry groups, standards committees, political/government agencies, in order to influence external stakeholders and promote Regulatory perspectives
- Lead by leveraging diverse perspectives, backgrounds and talent to generate effective ideas or solutions
- Deliver by acting with speed, flexibility , accountability and appropriately managing priorities to deliver results for on-time clearances and approvals
- Handles correspondence with overseas and local parties (both internal and external) in order to obtain or supply required information/ documents
Senior Regulatory Affairs Program Manager
09/2009
-
07/2016
San Francisco, CA
- Maintains relevant registration licenses, regulatory affairs-related information/ system, correspondence, and other relevant documentation for easy retrieval. Ensures that they are kept current, correct and confidential
- Maintains product registration information in TIRAS (Thailand & Indochina Regulatory Affairs System)
- Company’s Regulatory Compliance(Weights: 5%)
- Verified regulatory drug reports and ensures that they are maintained and/or submitted in a timely manner to the regulatory authorities in accordance with relevant regulations
- As assigned, manages RA activities on commercial release of imported products concerned to ensure that their packaging, product appearance and finished product specification comply with the regulatory approval
- Checks certificates of analysis of imported products to ensure that their contents comply with the registered finished product specification. Keep RA colleagues concerned informed of the difference, if any
- Regulatory Affairs Reports (Weights: 1%)
Senior Regulatory Affairs Engineer
05/2007
-
05/2009
Detroit, MI
- Supports the Regulatory Affairs Lead/ Senior Regulatory Affairs Manager/ Regulatory Affairs Manager in the timely preparation of reports, such as the Monthly Operating Report (MOR)
- Work with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products
- Create detailed Regulatory Plans. Includes in-depth team involvement and Core Team membership for complex projects
- Evaluate proposed product modifications for Regulatory impact on a worldwide basis, completing Regulatory Assessments as needed
- Ensure compliance with FDA and other applicable regulations and standards
- Ensure preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides
- Prepare responses to FDA questions and other Regulatory correspondence
Education
University of Pittsburgh
2001 - 2006
Bachelor's Degree in Pharmaceutical Science With
Professional Skills
- Good interpersonal skills and strong communication skills, team player
- Demonstrated project management skills preferable
- Good analytical thinking, problem solving and investigative skills are required
- Systems analysis skills desired
- Good interpersonal skill with excellent communication
- Expert Excel, Word, PowerPoint skills
- A demonstrated track record of developing and executing regulatory strategies that align with business deliverables is required
How to write Senior Regulatory Affairs Resume
Senior Regulatory Affairs role is responsible for training, database, reporting, design, research, assembly, travel, events, translation, government.
To write great resume for senior regulatory affairs job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Senior Regulatory Affairs Resume
The section contact information is important in your senior 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 Senior Regulatory Affairs Resume
The section work experience is an essential part of your senior 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 senior 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 senior regulatory affairs position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Senior Regulatory Affairs resume experience can include:
- Good understanding of regulatory compliance and knowledge of local
- Works with Clinical to achieve and maintain Good Clinical Practice compliance as required
- Reviews various changes made to existing products to assess the impact on safety and effectiveness
- Experience in the application of Title 21 of the US Code of Federal Regulations Parts 800-1299 (21 CFR 800-1299) is required
- Experience in the application of US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is required
- Experience in the application of Quality Management System Standard ISO 13485 is required
Education on a Senior Regulatory Affairs Resume
Make sure to make education a priority on your senior 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 senior 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 Senior Regulatory Affairs Resume
When listing skills on your senior 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 senior regulatory affairs skills:
- Experience in Quality & Regulatory Affairs including Regulatory approval experience
- Experience in Quality & Regulatory Affairs including Regulatory approval experience and specifically PreMarket Approvals with US FDA
- Experience in the application of the European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) and CE marking is required
- Experience within a process oriented working environment
- Significant experience in global regulatory affairs in the medical device, diagnostic, pharmaceutical or related industries
- Demonstrated ability to influence key stakeholders is required
List of Typical Experience For a Senior Regulatory Affairs Resume
1
Experience For Senior Regulatory Affairs Program Lead Resume
- Demonstrated track record of executing global regulatory strategies for both new and existing products, that align with business deliverables is required
- Completes required annual reporting, clinical/risk reporting, and device listing/registrations
- Participate in the development, review and approval of product labeling
- Ensures organizational compliance with international regulations and requirements pertaining to regulatory submissions
- Interacts with regulatory agency personnel to expedite approval of pending application and to resolve regulatory matters
- Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines
2
Experience For Senior Regulatory Affairs Program Manager Resume
- Provide solutions to extremely complex problems
- Provide regulatory guidance to project teams
- Provide support to inspections/audits by FDA, the notified body or other international regulatory bodies by producing requested documents or answering any inquiries for information
- Plans, coordinates, and executes regulatory submissions according to regulatory strategies to meet company objectives
- Serve as a regulatory liaison with FDA and international regulatory bodies on behalf of Torax to facilitate timely and favorable review of submissions and issues
- Coordinates expanding global presence with in country affiliates. Responsible for ensuring timely response to inquiries to global agencies
- Project team member for maintenance and initiation of IDE applications, Technical Files, and Premarket Approval Submissions and supplements. Responsible for informing management of project progress and establishing project timelines in accordance with department and corporate objectives
- Participates on project teams as primary Regulatory Affairs representative providing appropriate information on regulatory issues and obtaining needed information to meet regulatory requirements
- Maintains current knowledge base on existing and emerging regulations, standards, and guidance documents
3
Experience For Senior Regulatory Affairs Engineer Resume
- Reviews labeling for compliance with regulations and ensures that claims are substantiated and sustained
- Ensures organizational compliance with FDA regulations pertaining to regulatory submissions
- Provides regulatory review for internal change orders and other quality records to ensure regulatory compliance
- Works with Quality and Research & Development organizations to achieve and maintain FDA Quality System Regulation compliance and compliance with ISO requirements
- Directs and coordinates activities concerned with the maintenance of submission and approval of products to government regulatory agencies
4
Experience For Senior Regulatory Affairs Data Management Specialist Resume
- Provides guidance to business leadership to help maximize the strategy across functional areas
- Partners with EU, Regional, Policy, RALI leaders to monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations on the company's portfolio of products and help drive strategies to achieve a competitive advantage and benefit for the patients
- Works with team members and commercial partners to oversee the regulatory aspects of new products launches, and the assessment of the impact product changes have on the status of regulatory licenses
- Build and enhance external partnerships
- Lead and influence others without direct authority is required
5
Experience For Senior Regulatory Affairs Training Manager Resume
- Related experience in the pharmaceutical industry, with specific experience related to compilation, production and submission of regulatory dossiers in eCTD format
- Basic knowledge on ICH and FDA guidance, with focus on clinical regulatory and periodic report preparation
- Knowledge in the preparation of submissions in eCTD format
- Interpret local and global regulations to ensure that Ethicon products, processes, practices and procedures comply with quality standards
- Drive Franchise process improvements which have a significant impact for the Regulatory Affairs Department and cross-functional partners
- Ensure compliance under applicable laws, regulations, guidelines and company policies by strategically supporting the business and addressing problems/opportunities by generating alternatives to achieve desired outcomes that enable complaint promotional activities
- Maintain up to date knowledge of regulatory requirements and communicates changes to the Franchise in a timely manner
6
Experience For Future Senior Regulatory Affairs Engineer Opportunities Resume
- Conduct regulatory promotional labeling and marketing compliance reviews to ensure that materials and communications are consistent with product labeling, are adequately supported and comply with applicable laws, regulations and policies for all types of products, as appropriate
- Develop and provide input for policies, procedures and training related to advertising and Promotion and marketing compliance, as well as facilitate productive conversations to develop viable alternatives and solutions to help accomplish the identified communication goals
- Initiate and drive workflow optimization projects and implement technology optimization, and enforce the adherence of all copy and claims approvals to the defined standards
- Partner with cross-functional reviewers (e.g. Quality, Regulatory, Medical Affairs, Marketing, Healthcare Compliance, Legal, HE&R, Data Privacy, Communications, etc.) and manage non-conformance activities within the Ethicon Franchise Quality System
- Develops labeling specifications and approves proposed labeling and packaging, after evaluating conformance to regulations
- Review content of advertising and promotional materials to assure compliance with applicable regulations and J&J regulatory requirements
- Prepares responses and leads meetings for regulatory agencies' questions and other correspondence
7
Experience For Senior Regulatory Affairs Therapeutic Resume
- Provides solutions to extreme complex problems in which data analysis requires an evaluation of intangible variables
- Provides regulatory guidance to project teams
- Partner with Franchise RA team and internal partners (e.g., Marketing, Medical, Clinical, Pre-Clinical, Legal) to resolve issues related to promotional materials
- Pharmacovigilance activities and ensure for complying with national regulation for adverse events reporting or any regulatory safety monitoring activity
- Review promotional labelling
- Communicate regulatory requirements to originators of ad/promo materials
8
Experience For Senior Regulatory Affairs Office Resume
- Manage a significant amount of proprietary information in a confidential manner to prevent loss of intellectual property
- Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products (for example, represents Regulatory in the product recall and recall communication process)
- Handle and control label and packaging of imported products to comply with FDA’s regulations
- Follow up and answer FDA’s queries until obtain the registration approval
- Monitor and give regulatory advice on promotional/advertisement/related activities to business department in order to comply with FDA regulations/law
- Responsible for certificate of batch release for each batch of all vaccines imported
9
Experience For Senior Regulatory Affairs & Pharmacovigilance Executive Resume
- Maintenance the company license (Renewal Drug import license, Drug sale license, Medical device license
- COA translation for custom clearance purpose for all shipments and batches
- Coordinate document submission
- Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters, including salary administration
List of Typical Skills For a Senior Regulatory Affairs Resume
1
Skills For Senior Regulatory Affairs Program Lead Resume
- Experience in the application of US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is desired
- Good in English and computer literacy
- Working knowledge of how global regulations impact product registration is required
- Support in developing, reviewing and updating labelling material according to local legislation and SOP
- Find information/potential answers to challenging areas related to assigned projects in the interest of keeping the project streamlined and moving forward
- Strategic Planning and organizing
- B.Sc in Chemistry or Biochemistry or Food Processing or Food Engineering or equivalent is required
- Assist with technical preparation for FDA meetings, including review of draft questions and supporting documents
- Assist in compiling and organizing data and documentation for IND Amendments, Annual Reports, and General Correspondences
2
Skills For Senior Regulatory Affairs Program Manager Resume
- Assist in compiling and organizing data and documentation for NDA/BLA Supplements, Amendments, and Annual Reports
- Assist in the preparation of FDA Meeting Requests and Briefing Documents
- Supports and provides regulatory expertise to assigned medical devices and consumer product development projects from initial kickoff to post marketing phase
- Creation and execution of complex Regulatory Strategies and Plans for assigned medical devices and consumer products in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers
- Handle HAs or agents’ requests and demands on quality, clinical and non-clinical information according to NNAS standards/SOPs
- Proactively share regulatory intelligence with internal stakeholders on competitors’ products as well as on emerging regulations
3
Skills For Senior Regulatory Affairs Engineer Resume
- Knowledge of product marking requirements (by market)
- Assist Manager/Director in review of labeling for marketed products and new products as assigned
- Assist more senior personnel in managing projects
- Assist in reviewing clinical study reports, clinical protocols, investigator’s brochures, and investigator site initiation packages
- Assist in reviewing NDA/BLA Clinical and Nonclinical Modules
4
Skills For Senior Regulatory Affairs Data Management Specialist Resume
- Other activities as assigned, including regulatory affairs administrative activities
- Review the promotional materials to ensure overall legal compliance with HA’s requirements
- Control the quality of local language’s translation under supervision
- Maintain records on legislation, regulations and guidelines: check Health Authorities’ (HA) website, official gazette, offline systems, archive, ISOtrain
- Conduct research on submission requirements and options
- Monitor and report project timelines
- Monitor regulatory environment and ensure full compliance with relevant legislation and with internal SOPs
- Update and implement local regulatory procedures
5
Skills For Senior Regulatory Affairs Training Manager Resume
- Interact constantly with Health Authorities (HAs) to ensure timely approvals, detect regulatory trends and keep up-to-date with legislation at affiliate
- Maintain close interaction with local external stakeholders through an active presence in pharmaceutical associations and similar forums
- Communicate with internal stakeholders and regulatory authorities
- Prepare applications and regulatory documentation
- Review and assess regulatory submissions
- Utilize electronic submission techniques
- RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, desirable
- RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society is highly desirable
- The ability to work collaboratively in a highly matrixed environment is required
6
Skills For Future Senior Regulatory Affairs Engineer Opportunities Resume
- Build and sustain productive partnerships across multiple platforms is required
- Evaluate new regulatory requirements as well as regulatory changes and correctly assess business impact is required
- Plan and execute complex projects through timely completion with positive business results is required
- Knowledge of chemistry, flavor raw materials
- Knowledge of Chinese Food Safety Law (GB2760)
- Knowledge of Risk Management Standard ISO 14971 is required
7
Skills For Senior Regulatory Affairs Therapeutic Resume
- Familiarity with International medical device registration requirements (China, Japan, Canada, Australia, Brazil, Russia, etc.) is required
- Proficiency in Microsoft Office and all related applications is required
- Familiarity with Title 21 of the US Code of Federal Regulations Parts 800-1299 (21 CFR 800-1299) is required
- Experience in the application of the European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) and CE marking is required; EU MDR familiarity is desired
- Direct experience with international medical device registration (especially China, Japan, Canada, Australia, Brazil, and Russia) is required
- Familiarity with Risk Management Standard ISO 14971 is required
- Familiar with International Regulations, Standards and QS requirements
- Multi-task and take firm positions on tachnical issues when necessary to ensure compliance is maintained
- Medical Product knowledge preferable
8
Skills For Senior Regulatory Affairs Office Resume
- Knowledge of World Wide regulatory requirements
- Handle a variety of task and/or responsibilities
- Knowledge of FDA/GMP compliance requirements
- Prepares responses to regulatory agencies’ questions and other correspondence
- Assist in preparation of regulatory documents
- Compile applications and prepare for sign-off (INDs/NDAs/BLAs/510ks, IND amendments & Annual Progress
- Reports, NDA Annual Reports & Annual ADE Reports, IND Safety Reports, Drug & Establishment Listings, responses to FDA communications, among others as assigned), assure submission to government agencies in support of investigational and marketed products is completed in accordance with supervisor’s requirements and guidance
9
Skills For Senior Regulatory Affairs & Pharmacovigilance Executive Resume
- Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guidelines, and proactively provides guidance to ROI staff as needed during assembly of regulatory submissions
- Manage assigned project responsibilities, compose routine draft correspondence relevant to projects as assigned, such as letters of response, transmittal and memoranda where applicable. Use of templated correspondence as appropriate, ensuring that all new information is correct
- Prepare drafts of routine correspondence
- Prepare ROCs for routine FDA contacts
- Review information from local & NNAS contributing departments and provides comments to assure that documents are accurate and complete and comply with FDA regulations
10
Skills For Senior Regulatory Affairs & Export Control Specialist Resume
- Researches and consolidates global regulatory requirements and communicates this information to project teams and business partners and maintains information within team database
- Provides independent regulatory guidance to business partners and global Regulatory affiliates in strategic planning to support optimal timelines for new/modified product launches, communicates regulatory submission requirements
- Leads the preparation of global registration submission dossiers for new and existing products, by developing optimal submission strategies and sourcing and providing required documentation to meet timelines
- Good communication skills with peers
- Demonstration of positive interaction skills and work ethic
- Lead Regulatory Team member supporting continued access of new/modified/current Interventional Solutions products in key regions
- Utilizes strategic regulatory thinking along with technical expertise to implement regulatory strategies for new product clearances and approvals
- Represents Regulatory Affairs on cross-functional project teams as required
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