Regulatory affairs specialist resume examples from 2026

Q: How do you write a regulatory affairs resume?

You write a regulatory affairs resume by highlighting your prior work experience focusing on key soft skills and educational knowledge. Additionally, for resumes for regulatory affairs, it will be important to note any relevant certifications you have earned and any required licensing.

Q: What is regulatory work?

Regulatory affairs work is an industry that oversees how foods, drugs, and medical products are developed, tested, manufactured, marketed, and distributed to certify that they meet regulatory standards for human use. Regulatory affairs professionals are responsible for ensuring manufacturers' compliance.

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Updated March 26, 2025

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Regulatory affairs specialist resume

Tyler Murphy

(780) 555-3860 | tmurphy@example.com

San Diego, CA | 93759 S. Evergreen St. - 83103

Work experience

2020 - Present
Regulatory Affairs Specialist, Pfizer - San Diego, CA
- Follow up progress on regulatory submissions with PCO countries.
- Led the successful transfer of the entire Caribbean Regulatory activities to Costa Rica Operations.
- Communicated with Pfizer local country regulatory colleagues to determine regulatory requirements and CMC needs for global clinical submissions.
- Review the contents of such documents prior to submission to FDA to ensure their completeness.
- Reviewed / approved site procedures, validation protocols /reports.
2015 - 2020
Quality Assurance Auditor, Kaiser Permanente - Santa Clara, CA
- Reviewed all policies and procedures for compliance with local, State, and federal regulations.
- Created monthly reports for each facility's Medical Staff Board to measure core competencies and improve overall patient satisfaction.
- Communicated with global entities to facilitate investigations and compliance with corporate procedures.
- Evaluated current operating procedures from a three dimensional aspect.
2014 - 2015
Validation Specialist, Intel - Santa Clara, CA
- Tool was C-based, XML driven, and ran under Linux.
- Monitored and ran hardware tests for Intel 6th Gen chipset Modified and developed python scripts to help automate testing
- Tested bleeding edge technologies and software with Intel hardware.
- Created Validation Summary Report (VSR) to summarize overall validation activities.

Skills

Procedures
Process Validation
FDA
Financial Statements
Communication
Product Development
Regulatory Issues
Quality Procedures
Utility Systems
CFR

Education

Bachelor's Degree, Business (2006 - 2009)
San Jose State University
San Jose,

Regulatory affairs specialist resume

Richard Andrews

(660) 555-3878 | randrews@example.com

San Jose, CA | 7274 N. Oak St. - 50390

Work experience

2014 - Present
Regulatory Affairs Specialist, CARDIMA - San Jose, CA
- Mentored new employees and conducted training on regulatory procedures.
- Planned and executed Regulatory strategies for domestic and international manufacturing site transfers.
- Keep current with Medicaid/Medicare, and Worker's Compensation policies and procedures.
- Prepare regulatory submissions to secure timely approvals in support of business initiatives.
- Interfaced with the FDA and Consumer Product Safety Commission (CPSC) via teleconferences and face-to-face meetings.
- Designed and distributed quarterly internal e-newsletter to communicate potential regulatory issues across functional areas of the company.
2009 - 2014
Regulatory Affairs Specialist, Intuitive Surgical - San Jose, CA
- Contribute a regulatory perspective to product development teams.
- Prepare documents, as directed, for internal use or submission to regulatory authorities.
- Prepare local labeling deviation forms, based on queries from the Health Authorities.
- Provided regulatory support for new and ongoing research studies including filings, document creation and maintenance.
2007 - 2009
Clinical Research Assistant, Clinimetrics - San Jose, CA
- Communicate with sponsors, site and Clinimetrics colleagues to ensure effective project management.
- Maintain and track study data (enrollment and CRF collection).
- Conducted literature reviews for two aging and home health care projects.
- Assisted the PI and others on developing and writing original research projects with the goal of publication.

Skills

State Agencies
Regulatory Submissions
Regulatory Authorities
Research Projects
Study Protocol
Data Management
MRI
CPR
Promotional Materials
Medical Records

Education

Bachelor's Degree, Business (2004 - 2007)
San Jose State University
San Jose,

Regulatory affairs specialist resume

Susan Cox

(450) 555-7707 | scox@example.com

Charlotte, NC | 10384 S. Evergreen Ave. - 32426

Work experience

2011 - Present
Regulatory Affairs Specialist, Bank of America - Charlotte, NC
- Developed and updated departmental procedures, ensuring the team s payment posting processes are compliant with the most current company policies.
- Help create procedures and document the regulatory filing process to enhance efficiency of filings.
- Reviewed and approved labels, revised to meet ISBT 128 standards, for successful submission to FDA.
- Developed new and revise current processes and standard operating procedures.
- Coordinate meetings with KPMG to evaluate best practices and meet with department heads to implement procedures while maintaining meeting minutes.
- Managed several projects with a regulatory submissions focus.
2009 - 2011
Regulatory Administrator, Bank of America - Charlotte, NC
- Experienced on Maintaining & troubleshooting SAN and Fiber Channel Card related on LINUX and UNIX Operating systems.
- Root cause analysis after Panic/Dump/Crash related to Linux and Solaris by co-coordinating with Vendors for permanent resolution.
- Verify and investigate consumer complaints and respond to them with the regulatory agencies.
- Create and update department procedures Demonstrate the technical ability to perform server UNIX commands Maintaining audio fidelity of the call.
2002 - 2009
Regulatory Affairs Associate, Pepco Holdings - College Park, MD
- Support the Company's business plan through the development of cost of service studies for regulatory proceedings and regulatory filings.
- Participated in all aspects of the production and review of daily, monthly, quarterly, and semi-annual Regulatory Filings.
- Update regulatory technical files and review documentation and preparation of regulatory and associated dossiers.
- Prepared all initial regulatory submissions, protocol amendments and continuing review reports submissions to their appropriate regulatory authority agency.
- Participate in coordinating all aspects of regulatory submissions and responses and regulatory management of reformulation products.

Skills

Project Management
ISO
Quality Standards
Regulatory Agencies
State Regulations
Regulatory Issues
Regulatory Information
Institutional Review
Product Development
Regulatory Submissions

Education

Bachelor's Degree, Biology (1994 - 1997)
University of Maryland - College Park
College Park,

Regulatory affairs specialist resume

Bryan Sanders

(520) 555-9613 | bsanders@example.com

Round Lake, IL | 59710 E. First St. - 93716

Work experience

2019 - Present
Regulatory Affairs Specialist, Baxter Regional Medical Center - Round Lake, IL
- Developed and implemented regulatory strategies for electronic submissions to agencies in U.S. and Europe.
- Maintain electronic and historical regulatory files of submissions to regulatory authorities in accordance with record retention guidelines.
- Collaborate with 3rd party companies for US regulatory submissions.
- Manage regulatory activities relating to the company core safety information for base solutions in the Baxter's Fluid Systems franchise.
2018 - 2019
Regulatory Administrator, JPMorgan Chase - Chandler, AZ
- Reset passwords for Midrange, Windows, Unix, and Mainframe accounts
- Train new employees as well as current employees from other platforms on the procedure for processing requests on the UNIX platform.
- Configured VMware and installed several Linux and Windows Operating Systems according to the client needs.
- Installed and configured TIBCO EMS servers on developer's workstations and UNIX machines.
- Administer users, connections, roles and permissions via Informatica and within Unix.
2017 - 2018
Study Coordinator, Premier - Chandler, AZ
- Acted as the point person for end of study data reconciliation with the CRO and clinical sites.
- Collaborated with clients and consultants to change and improve protocols.
- Maintained the trial master file and ensured a high level of quality for all study documents.
- Supervised and conducted data collection.
- Act as liaison between research and data collection staff.

Skills

QC
Internal Database
Regulatory Support
Counsel
Procedures
Dossiers
Regulatory Agencies
Regulatory Issues
Administrative Functions
Study Protocol

Education

Bachelor's Degree, Business (2009 - 2012)
American InterContinental University
Chandler,

Regulatory affairs specialist resume

Scott Wilson

(290) 555-3303 | swilson@example.com

Warsaw, IN | 34501 E. Second St. - 65411

Work experience

2017 - Present
Regulatory Affairs Specialist, Zimmer Biomet - Warsaw, IN
- Aided in development of regulatory strategy for remediation project for Zimmer Biomet.
- Write, prepare, and submit medical device and manufacturer registration application dossiers to the governments of India and Taiwan.
- Managed regulatory projects, coordinating regulatory related activities and provided regulatory supports for sterile/non-sterile products, small and monoclonal antibodies molecules.
- Scanned and imported PDF renditions of regulatory submissions into the Documentum database.
2016 - 2017
Marketing Analyst, JPMorgan Chase - Columbus, OH
- Achieved optimal PPC results by continual optimization of budget and campaigns.
- Gained advanced knowledge on Underwriting procedures specific to Independent Foreclosure Review process.
- Relay appropriate resolutions to specify government agencies such as Deloitte and Touch consulting as appropriate.
- Developed and executed marketing collateral for new product launches, customer case studies, and web copy.
2014 - 2016
Market Research Analyst, JPMorgan Chase - Columbus, OH
- Promoted as an Archivist to reopen completed cases to ensure it adheres to the procedures and compliance.
- Performed OFAC related investigations on entities as well as its directors among other determinations according to USA PATRIOT Act.
- Assisted with the development, design, and input process for new procedures related to modification and foreclosure complaints.
- Developed in-house database, analyzed market research to recommend marketing tools.

Skills

A/B
Regulatory Changes
Business Units
ROI
Product Demand
Product Development
Special Projects
Real Estate
Regulatory Strategies
Research Projects

Education

Bachelor's Degree, Business (2011 - 2014)
Ohio State University
Columbus,

How to write a regulatory affairs specialist resume

Craft a resume summary statement

Your resume summary sums up your experience and skills, making it easy for hiring managers to understand your qualifications at a glance. Here are some tips to writing the most important 2-4 sentences of your resume:

Step 1: Mention your current job title or the role you're pursuing.

Step 2: Include your years of experience in regulatory affairs specialist-related roles. Consider adding relevant company and industry experience as relevant to the job listing.

Step 3: Highlight your greatest accomplishments. Here is your chance to make sure your biggest wins aren't buried in your resume.

Step 4: Again, keep it short. Your goal is to summarize your experience and highlight your accomplishments, not write a paragraph.

These tips will help you demonstrate why you are the perfect fit for the regulatory affairs specialist position.

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List the right project manager skills

Your Skills section is an easy way to let recruiters know you have the skills to do the job. Just as importantly, it can help your resume not get filtered out by hiring software. Here is how to make the most of your skills section and make sure you have the right keywords:

You often need to include the exact keywords from the job description in your resume. Look at the job listing and consider which of the listed skills you have experience with, along with related skills.
Include as many relevant hard skills and soft skills as possible from the listing.
Use the most up to date and accurate terms. Don't forget to be specific.

These five steps should give you a strong elevator pitch and land you some regulatory affairs specialist interviews.

Here are example skills to include in your “Area of Expertise” on a regulatory affairs specialist resume:

Regulatory Affairs
FDA
Regulatory Agencies
Medical Devices
Regulatory Compliance
Regulatory Submissions
Patients
Excellent Interpersonal
Regulatory Authorities
Regulatory Issues

EU
Regulatory Strategies
PMA
Product Development
ISO
Regulatory Support
Dossiers
MDR
Regulatory Filings
IRB

Clinical Trials
III
International Regulations
GCP
Regulatory Guidance
Informed Consent
Product Registrations
MDD
CFR
Management System

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How to structure your work experience

Your work experience should be structured:

With your most recent roles first, followed by earlier roles in reverse chronological order.
Job title, along with company name and location on the left.
Put the corresponding dates of employment on the left side.
Keep only relevant jobs on your work experience.

How to write regulatory affairs specialist experience bullet points

Your resume is not a list of responsibilities or a job description. Instead, it is your chance to show your accomplishments and show why you're good at what you do.

Use the What, How, and Why format. Answering these questions turns a bland job description into an effective showcase of your abilities.
What were your responsibilities or goals?
How did you accomplish them?
Why were your results important? (How did it impact your company? Can you quantify the results in numbers? )

Here are examples from great regulatory affairs specialist resumes:

Work history example #1

Regulatory Affairs Specialist

Merck & Co.

Performed statistical analysis of stability data generated on pharmaceutical market approved products for specification trend analysis.
Maintained database of release and stability data generated on pharmaceutical market approved products.
Positioned as CMC regulatory lead for sterile products including a hospital-use only broad spectrum antibiotic and an oncology product.
Coordinated CMC activities and authored multiple CMC sections in support of new and existing drug product registrations US and worldwide.
Directed troubleshooting in preparation for Advisory Board meeting; averted potential emergency due to insufficient information technology support.

Work history example #2

Quality Associate

Anixter

Created training communications targeting internal departments to increase awareness of Quality training course offering.
Implemented and maintained the registration of the Quality Management System to the ISO 9000 Standard.
Received Certificate For PC-DMIS CMM Machine Measurement Software in 1995.
Prepared PPAP documents; Control Plan, Flow Charts, Process Drawings, PSW's and PFMEA's.
Performed SPC gauging as required and light tunnel testing.

Work history example #3

Public Affairs Assistant

Department of Homeland Security

Assisted Limited English Proficiency individuals with registering for FEMA assistance.
Distributed 108 FEMA News Releases to Congressional district offices affected by the tornado and flooding disasters.
Leveraged entrepreneurial orientation and expertise in government transactions to acquire excellent relationships outside of FEMA.
Facilitated public affairs and crisis communications training support to combatant commands.
Developed and led proactive campaigns that reached nearly 2,000,000 people on Twitter.

Work history example #4

Quality Associate

Blue Cross and Blue Shield of Florida

Conducted Telephone, in-person, and on-the record hearings which determine if a beneficiary / supplier receive payment from Medicare.
Synchronized data among multiple systems.
Supervised Staff for Financial Suspense Department
Prepared Plan for NCQA Accreditation for two survey periods.
Redesigned and built new QA laboratory and sample retain area.

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Add an education section to your resume

Employers are looking for a few things when looking at the Education section of your resume:

The highest degree you have achieved.
TWhere you attended school, and the dates (Although if you graduated some time ago, leave the date off to avoid ageism)
TField of study
TAny honors, relevant coursework, achievements, or pertinent activities

Here are some examples of good education entries for resumes:

Bachelor's Degree in business

San Jose State University, San Jose, CA

2006 - 2009

Bachelor's Degree in business

San Jose State University, San Jose, CA

2004 - 2007

Highlight your regulatory affairs specialist certifications on your resume

Certifications are a great way to showcase special expertise or niche skills. Some jobs even require certifications to be hired.

Include the full name of the certification, along with the name of the issuing organization and date of obtainment.

If you have any of these certifications, be sure to include them on your regulatory affairs specialist resume:

Regulatory Affairs Certification - US (RAC)
Certified Clinical Research Professional (CCRP)
Certified Quality Auditor (CQA)
Certified Pharmacy Technician (CPhT)
Certified Clinical Research Coordinator (CCRC)
Incident Safety Officer - Fire Suppression Certification (ISO)
Certified Billing and Coding Specialist (CBCS)

Regulatory affairs specialist resume FAQs

How do you write a regulatory affairs resume?

What is regulatory work?

Have more questions? See all answers to common business and financial questions.

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Updated March 26, 2025

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