Regulatory affairs manager resume examples from 2026

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Updated March 26, 2025

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Regulatory affairs manager resume

Amber Russell

(410) 555-4813 | arussell@example.com

North Haven, CT | 97799 E. Park Ave. - 47779

Work experience

2016 - Present
Regulatory Affairs Manager, Medtronic - North Haven, CT
- Provided regulatory support to key products and projects.
- Collected, reviewed and tracked regulatory documentation for study site activation in accordance with standard operating procedures and GCP ICH guidelines.
- Evaluate change controls in Trackwise system for CMC regulatory impact to international countries.
2013 - 2016
Scientist, Biogen - Cambridge, MA
- Contributed to an antibody's (targeting RRMS) R to D transition.
- Prepared, reviewed, and QC'd protocols and validation reports for on-site GLP sample testing.
- Developed and streamlined assays used to generate EC50 data for small molecule candidates, enabling timely completion of pre-clinical studies.
2003 - 2013
Research Scientist, Arizona State University - Chandler, AZ
- Worked with research economists on banking research projects.
- Maintained and calibrated all instruments that are involved in the processes and kept procedures up to date.
2000 - 2003
Assistant Scientist, Arizona State University - Chandler, AZ
- Designed experimental procedures in regard to grant-specific laboratory aims and plans.
- Worked closely with contract manufacturing facilities qualifying new technologies, ensuring compliance of USDA requirements in formula and process.
- Served as the Lead Analytical Scientist for multiple projects carrying out analytical activities and experiments * Developed analytical methods (i.e.
- Supervised purification operations in the Multiproduct Cell Culture Protein Purification Facility (MPCCPPF).

Skills

Procedures
Technical Reports
Business Partners
Clia
CMC
QC
R
Regulatory Information
Final Reports
Analytical Methods

Education

Doctoral Degree, Business (1997 - 2000)
American InterContinental University
Chandler,
Master's Degree, Human Resources Management (1996 - 1997)
DeVry University
Oakbrook Terrace,
Bachelor's Degree, Business (1993 - 1996)
American InterContinental University
Chandler,

Regulatory affairs manager resume

Lisa Boyd

(550) 555-7329 | lboyd@example.com

West Greenwich, RI | 77161 W. Oak Ave. - 13192

Work experience

2020 - Present
Regulatory Affairs Manager, Amgen - West Greenwich, RI
- Served as the Oncology Team Leader for international reporting of regulatory submissions / data for facility compliance and licenses.
- Modified cover letter templates to FDA and uploaded transfer of obligations for CROs.
- Responded to CMC questions in collaboration with internal and local CMC functions.
- Responded to CMC, and non-clinical questions working in collaboration with a CRO and internal subject matter experts.
2018 - 2020
Quality Assurance Supervisor, Pfizer - Collegeville, PA
- Managed and administrated Quality Standards and Compliance systems which include global Level One manufacturing standards and twelve different SOP systems.
- Monitored the status of validation/qualification and preventative maintenance for lab equipment and correspond with Maintenance, QA and Building Coordinator.
- Reviewed documentation associated with raw materials, intermediate and finished product.
2008 - 2018
Leading Petty Officer, Georgia-Pacific Chemicals - Grayling, MI
- Followed set procedures and exercised independent judgment in carrying out instructions.
- Managed the qualifications of 120 sailors in all aspects of shipboard watch qualifications.
- Organize and supervise emergency repair teams by conducting real time scenarios and conduct mandatory training.
- Completed Electronic Warfare C School Pensacola, Fla.4.
- Instructed over 350 personnel on the Operations Security (OPSEC) program procedures.
- Achieved 100% advancement of 21 trained junior sailors.
2004 - 2008
Reactor Operator, Georgia-Pacific Chemicals - Grayling, MI
- Planned and performed maintained and operations on S6G nuclear power plant.
- Performed complex troubleshooting and repair operations on nuclear power indication and reactor control rod systems.
- Monitor and control the nuclear power plant from the control room within design and operating bands.
- Followed safety procedures for transporting hazardous goods.

Skills

Procedures
Quality Checks
Electrical Systems
Sailors
SSN
SQL
Nuclear Power
Regulatory Support
Regulatory Agencies
Plant Equipment

Education

Bachelor's Degree, Business (2001 - 2004)
Monroe College
Bronxville,

Regulatory affairs manager resume

Harold Andrews

(990) 555-8488 | handrews@example.com

San Bernardino, CA | 43603 N. Second Ln. - 60391

Work experience

2014 - Present
Regulatory Affairs Manager, Rabobank, N.A. - San Bernardino, CA
- Identify, prioritize and deliver on key initiatives relating to compliance risk management program.
- Developed and enforced compliance policies and procedures.
- Drafted and revised policies and procedures on all substantive bank activities prior to adoption.
- Maintained all state and EPA regulatory, as well as MSDS and product labels.
- Developed continuity and trust among team members and direct reports.
2013 - 2014
Regulatory Specialist, City of Corona - City Government - San Bernardino, CA
- Avoid lengthy and unnecessary product recall by drafting regulatory compliance question to Office of Chief Counsel * Draft preamble for proposed rule
- Reviewed / approved site procedures, validation protocols /reports.
- Ensured site regulatory documents and site contract / budget were complete prior to site initiation / release of investigational product.
- Perform final quality check of electronic versions of regulatory submissions.
- Assist in auditing/monitoring clinical trials and/or field investigation studies.
- Led the development, analysis and evaluation of Bureau-wide compliance policies, procedures and productivity standards.
2012 - 2013
Clinical Research Coordinator, Kforce - San Bernardino, CA
- Train on-site team, including the investigator and other site personnel, in proper conduct of clinical studies.
- Provided in-house support for regional CRAs monitoring mega-trial.
- Supported the regional field monitors by performing co-monitoring visits for Oncology trials.
2010 - 2012
Clinical Research Associate, Harley-Davidson - San Bernardino, CA
- Maintain Database -Analyze research data -In collaboration with investigators, develops and documents standard operating procedures and trial protocols.
- Provide oversight of a study to ensure progress according to study timelines.
- Participate in the development of monitoring procedures and standards and assure consistent implementation.

Skills

Promotional Materials
Institutional Review
RN
Regulatory Strategies
Federal Regulations
CRS
Regulatory Documents
Data Management
Oncology
III

Education

Bachelor's Degree, Business (2001 - 2004)
California State University - San Bernardino
San Bernardino,

Regulatory affairs manager resume

Elizabeth Moore

(600) 555-0869 | emoore@example.com

Columbia, SC | 36580 S. Cedar Ave. - 77664

Work experience

2019 - Present
Regulatory Affairs Manager, American Pipe and Supply - Columbia, SC
- Participated in multiple meetings and teleconferences with FDA.
- Implemented standardized procedures enterprise wide to allow better review of suspicious activity reporting and compliance with BSA/AML FinCEN standards.
- Improved food safety and quality by implementing microbiological studies and solid sanitation procedures at five plant locations within one year.
2016 - 2019
Quality Assurance Supervisor, Verizon - Columbia, SC
- Benchmarked corporations for quality standards.
- Key Accomplishments: Crafted new audit procedures resulting in 40+ hours of saved audit time.
- Coach coordinators to help improve Quality metrics and overall Productivity.
- Audited completed national orders to ensure compliance and accuracy.
- Developed test plans on all CQA systems utilizing systems analysis techniques and procedures.
2013 - 2016
Leading Petty Officer, United States Marine - Beaufort, SC
- Ensured that crew members were fully trained on security procedures and were able to successfully complete security exercises.
- Coordinated training for engineering department including classroom and hands-on casualty response training.
- Originated and established standard operating procedures streamlining all core operational procedures.
- Supervised all operations performed by 40+ sailors.
2010 - 2013
Reactor Operator, Rea Magnet Wire - West Lafayette, IN
- Operated excavator Sennebogen 840,850,and 870 Operated front end loader, fork lift and heavy duty dump truck's.
- Operated assembly line for auto part, was materal handler
- Performed analytical testing and verification of all incoming raw materials and sampled and ran analytics on finished product.

Skills

Diesel Generators
CMC
Nuclear Power
Abnormal Conditions
Control Room Operations
ISO
HR
Sailors
Regulatory Submissions
Outage

Education

Bachelor's Degree, Pharmacy (2007 - 2010)
Purdue University
West Lafayette,

Regulatory affairs manager resume

Julia Turner

(930) 555-0893 | jturner@example.com

Los Angeles, CA | 29743 S. Second Ave. - 56699

Work experience

2020 - Present
Regulatory Affairs Manager, Robert Half International - Los Angeles, CA
- Developed and wrote all process validation, recall policy, document/engineering change control and training procedures.
- Conducted technical meetings with regulatory advisory committees and government agencies.
- Experience using the Lorenz Validator to ensure that submissions meet the FDA standards.
- Reviewed all scientific data for regulatory submissions.
- Trained on regulatory labeling policies and procedures, as required.
- Take lead in electronic assembly and publishing of regulatory submissions.
2017 - 2020
Quality Assurance Manager, Robert Half International - Los Angeles, CA
- Worked with third-party and in-house laboratories to establish requirements and feasibility of testing procedures.
- Involved in System Integration, Regression, UAT testing, parallel testing, End-to-End Business Testing & Agile Methodology testing project.
- Created a new software development methodology, improving all standards and procedures including automated testing.
- Test the accuracy and classification of account balances through analytical procedures and analysis of the accounting functions for each client.
2015 - 2017
Consultant, Robert Half International - Los Angeles, CA
- Design evaluation tool for new contracts to allow for quick setup in compliance with guidance.
- Write conversion scripts in T-SQL/Management Studio [ ] * Programmed C# web services in Visual Studio IDE.
- Maintain payroll-related accounts and responsible for multi-state payroll administration and orientation preparation.
- Maintain Active Directory add, remove & modify users accounts.
- Led new business development and project teams for the Consulting organization within IRI.
- Created vbs programs to extract Blob from SQL server 2012 database and save in corresponding .xls and .csv formats.
2012 - 2015
Product Developer, Motorola Solutions - Tempe, AZ
- Chaired change control meetings, and reviewed product test and QA functions.
- Devour Motorola Lens optical activities and development technical advisor 13 patent disclosures were written related to product development activities.
- Defined product roadmap authored technical product requirements and led product development efforts.
- Coordinated product development for new Iridium2 subscriber handheld phone utilizing $4,000,000,000 Iridium satellite system.
- Managed the business analysis, technical writing and project management teams.

Skills

Product Development
Quality Standards
Regulatory Strategies
Health Authorities
Data Warehouse
Customer Service
Project Management
Process Control
Business Development
Quality Procedures

Education

Bachelor's Degree, Management (2009 - 2012)
Colorado Technical University
Colorado Springs,

How to write a regulatory affairs manager 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 manager-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 four steps should give you a strong elevator pitch and land you some regulatory affairs manager interviews.

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List the right project manager skills

Your Skills section is a place to list all relevant skills and abilities. 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 manager interviews.

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

Regulatory Affairs
FDA
Medical Devices
Regulatory Submissions
Regulatory Agencies
Global Regulatory
Regulatory Strategies
Project Management
Regulatory Compliance
EU

Product Development
Regulatory Authorities
NDA
Regulatory Issues
IND
CMC
Regulatory Guidance
Excellent Interpersonal
ICH
Health Authorities

Clinical Trials
Regulatory Support
ISO
ECTD
Lifecycle Management
Regulatory Filings
Regulatory Bodies
International Regulations
III
Quality System

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How to structure your work experience

A work experience section is a vital part of your resume because it shows you have the experience to succeed in your next job.

Put your most recent experience first. Prospective employers care about your most recent accomplishments the most.
Put the job title, company name, city, and state on the left. Align dates in month and year format on the right-hand side.
Include only recent, relevant jobs. This means if you're a fairly experienced worker, you might need to leave off that first internship or other positions in favor of highlighting more pertinent positions.

How to write regulatory affairs manager experience bullet points

Effective job bullet points do more than just describe your job duties. Instead, they should be specific and measurable accomplishments. Here are some strategies to mastering job bullet points:

Use strong action verbs like Led, Built, or Optimized.
Follow up with numbers when possible to support your results. How much did performance improve? How much revenue did you drive?
Wrap it up by explaining the actions you took to achieve the result and how you made an impact.

Here are examples from great regulatory affairs manager resumes:

Work history example #1

Regulatory Affairs Manager

Pharmaceutical Product Development

Prepare ANDA submission for drugs seeking approval from US FDA.
Performed document and submission activities for 5 Oncology studies and 6 Endocrinology studies
Reviewed FDA reporting of promotional materials and submissions.
Prepared medical device 510(k) for Sepramesh IP, received FDA clearance after 60 days.
Support US Regulatory activities, including building FDA submissions, drafting of formal FDA submission letters, and managing publishing workload.

Work history example #2

Chemist

Johnson Matthey

Prepared quantitative and qualitative analysis of precious metals for finished products.
Analyze and identify compounds utilizing a range of analytical techniques (NMR, HPLC, TLC, GC/MS).
Perform syntheses of Active Pharmaceutical Ingredients (API) under cGMP protocol.
Performed review and approval of QC data of raw materials, intermediates, and final products.
Maintained and promoted GMP standards.

Work history example #3

Quality Assurance Analyst

IBM

Develop API's to automate the creation of multiple network architectures on the Openstack controller in Python.
Conducted End-to-End and Regression Automation of HAP Application using the tool QTP 11.
Prepared jobs (JCL) based on design.
Tested components on several UNIX and Windows platforms.
Evaluated data collected from various x-ray and ultra sound equipment and generated technical reports reflecting extensive results.

Work history example #4

Quality Engineer

FedEx

Consulted Quality Action Teams (QATs) and guided them to successful project implementations utilizing Six Sigma tools.
Assisted teams with measuring and evaluating the post-project success.
Used data base user interface and SQL.
Prepared educational material that equipped team members to improve their processes.
Advised project leaders with prediction and quantification of quality benefits resulting from a project.

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Add an education section to your resume

The education section should display your highest degree first.

Place your education section appropriately on your resume. If you graduated over 5 years ago, this section should be at the bottom of your resume. If you just graduated and lack relevant work experience, the education section should go to the top.

If you have a bachelor's or master's degree, do not list your high school education. If your graduation year is more than 15-20 years ago, it's better not to include dates in this section.

Here are some examples of good education entries from regulatory affairs manager resumes:

Doctoral Degree in business

American InterContinental University, Chandler, AZ

1997 - 2000

Bachelor's Degree in business

Monroe College, Bronxville, NY

2001 - 2004

Highlight your regulatory affairs manager certifications on your resume

Certifications can be a crucial part of your resume. Many jobs have required certifications.

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 manager resume:

Regulatory Affairs Certification - US (RAC)
Certified Clinical Research Professional (CCRP)
Certified Quality Auditor (CQA)
Clinical Trial Investigator (CTI)
Certified Regulatory Compliance Manager (CRCM)

Updated March 26, 2025

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