5 Regulatory Affairs Resume Examples & Guide for 2023

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5 Regulatory Affairs Resume Examples...

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Top Regulatory Affairs sections that make the best resume

  • Header
  • Professional summary
  • Experience (with numbers & results)
  • Relevant skills
  • Education
  • Certifications

Things to remember when writing your Regulatory Affairs experience section

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Regulatory Affairs Experience Section Checklist:
  • Keep it short: use no more than 4-6 bullet points per position;
  • Go for short, easy-to-read sentences to keep recruiters engaged;
  • Focus on relevant job experience that will enhance your application;
  • Describe your experience using the C-A-R (challenge, action, result) methodology;
  • Ditch buzzwords and go for power words instead.

Use the examples below to build your own experience section!

Work Experience
Regulatory Affairs Specialist
ABC Pharmaceuticals
06/2019 Present
  • Coordinated and organized regulatory information, data, documents, and other information in support of regulatory filings or procedures, resulting in a 30% reduction in submission errors
  • Managed Regulatory Authority Communication Logs, Compliance activity logs, Product Portfolio, and Asset Information, leading to a 25% increase in compliance rate
  • Ensured all regulatory documentation was compliant with Standard Operating Procedures (SOP’s) for format, content, and storage, reducing the need for re-submissions by 20%
  • Provided summaries of complex communication and follow-up to ensure proper and timely action was taken in the Regulatory Affairs Centralized Services function, resulting in a 15% increase in efficiency
  • Scheduled meetings, tracked expenses, and made travel arrangements, resulting in a 10% reduction in scheduling errors and travel costs
Work Experience
Regulatory Affairs Associate
XYZ Medical Devices
01/2017 06/2019
  • Assisted in the preparation, assembly, and submission of regulatory filings for medical devices, leading to the successful approval of 5 products
  • Compiled and maintained regulatory documentation databases and information management systems in compliance with regulatory requirements, reducing the need for resubmissions by 15%
  • Provided administrative support for the activities conducted by the Regulatory Affairs Department, including scheduling meetings and tracking expenses
  • Ensured compliance with regulatory requirements and internal policies, resulting in zero compliance violations during audits
  • Assisted in the preparation and review of regulatory documents to ensure high-quality submissions, resulting in a 20% reduction in submission errors
Work Experience
Regulatory Affairs Manager
ABC Pharmaceuticals
01/2017 06/2022
  • Led preparation and submission of INDs, NDAs, and annual reports resulting in 100% approval rate from regulatory agencies.
  • Organized and facilitated regulatory agency meetings resulting in successful outcomes, including FDA approval of a new indication for an existing product.
  • Collaborated with internal stakeholders to develop and optimize regulatory processes and procedures resulting in a 20% reduction in submission timelines.
  • Provided regulatory intelligence on changing landscape resulting in successful implementation of new regulations and standards.
  • Managed multiple projects simultaneously resulting in timely completion of all regulatory activities.
  • Mentored and trained junior regulatory affairs professionals resulting in their successful growth within the company.
Work Experience
Senior Regulatory Affairs Specialist
XYZ Biotech
01/2014 12/2016
  • Authored and edited INDs, briefing documents, and other regulatory submissions resulting in successful approval from regulatory agencies.
  • Coordinated with cross-functional teams to ensure timely submission of all regulatory documents resulting in meeting all deadlines.
  • Participated in agency meetings, provided guidance on regulatory requirements, and responded to regulatory authorities resulting in successful outcomes.
  • Reviewed and interpreted regulatory requirements and provided guidance to cross-functional teams resulting in compliance with applicable regulations.
  • Managed regulatory submissions for multiple products resulting in timely approval of all submissions.
Work Experience
Regulatory Affairs Specialist
2019-01-01 2021-12-31
  • Assisted with the development and/or review of regulatory documents resulting in the submission of 5 high-quality submissions per quarter.
  • Coordinated, and organized regulatory information, data, documents, and other information resulting in a 20% increase in efficiency.
  • Provided summaries of complex communication and follow-up resulting in proper and timely action taken in the Regulatory Affairs Centralized Services function.
Work Experience
Regulatory Affairs Associate
2017-01-01 2018-12-31
  • Assisted in the preparation of 10 regulatory dossiers per quarter resulting in a 15% increase in the efficiency of the Regulatory Affairs team.
  • Provided meeting minutes or dashboard updates to/for related activities resulting in a 20% increase in communication efficiency within the department.
  • Scheduled meetings, tracked expenses, and submitted purchase orders resulting in efficient financial management of the department.
Work Experience
Regulatory Affairs Intern
Molecular Devices
2016-01-01 2016-05--12
  • Assisted in the preparation of presentation materials resulting in a 25% increase in communication efficiency within the department.
  • Provided summaries of complex communication resulting in proper and timely action taken in the Regulatory Affairs Centralized Services function.
  • Scanned, filed, and archived documents in compliance with regulatory requirements.
pro tip icon

Include quantitative data throughout your Regulatory Affairs resume to impress the hiring manager. Real facts and figures that show off your competency as an audit manager go a long way. Did you reduce the costs of audits? Manage a large team? Boosted efficiency? Show off the real numbers!

Action Verbs for your Regulatory Affairs Resume

Action verbs will make your [Job Title] resume sound relevant and professional. They will also help you make a strong first impression. Make sure to use them whenever possible!

Impressing Recruiters with a Top Regulatory Affairs Resume Skills Section

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Regulatory Affairs resume: skills section checklist
  • Scan the job advert for keywords worth including in your resume;
  • List both hard and transferable skills;
  • Leave room for discussion: include some of your skills in other sections of your resume;
  • Focus on skills that prove your expertise and leave the irrelevant ones behind.
Top skills for your regulatory affairs resume

Regulatory submissions

Quality assurance

Risk management

Document control

FDA regulations

Medical device regulations

Pharmaceutical regulations

Clinical trial design

ISO standards

Product labeling



Attention to detail

Analytical thinking


Problem solving

Time management


Organizational skills

Interpersonal skills


pro tip icon

When picking skills to feature in your resume, make sure they'll be relevant to the position you’re applying to. The point of listing skills is for you to stand out from the competition. Stay away from repetitive, meaningless skills that everyone uses in their resumes. Or else, they’ll backfire and make you look like an average candidate.

what to write in your resume header
Checklist icon
Regulatory Affairs resume summary checklist:
  • Mention your position and total years of experience in the field;
  • Highlight 1-2 of your top achievements;
  • Go for shorter sentences and keep them to the point – don’t include anything that doesn’t support your application;
  • Add 2-4 keywords present in the job description.
resume Summary Formula icon
Resume summary formula:
Resume Summary Formula: [Adjective] [job title] with [number] years of experience in [industry], a proven ability to [relevant, measurable skills], and a strong background in [relevant context of your work experience] seeks a position as [the job title you’re applying for].
pro tip icon

Your summary section should act as a professional taster. Use it wisely. Effectively convey your professional profile and let the hiring manager know that if they hire you, they won’t be disappointed. Make sure to include keywords from the job description too! Elaborate on your abilities further in your experience section. Again, cater to the job description.

Choosing the Best Format for Your Regulatory Affairs Resume

The content of your Regulatory Affairs resume is what will get you hired, right?

But even when your content’s amazing and you’re a true over-achiever, recruiters might not think you’re a good fit if your resume looks messy or is not formatted the right way.

In general, there are three basic resume formats we advise you to stick with:

Deciding which one to use depends on your experience, the industry, and the company. In short — you need to know what your applicant profile is.

For instance, reverse-chronological resumes are great for people with over 10 years of experience and no employment gaps. Here, you need to list all your relevant experience in a reverse-chronological format, starting from the most recent and going back to less recent positions.

Functional skills-based resumes, on the other hand, are great for entry-level applicants, graduate students, or people who have different kinds of experience. It focuses on skills, education, and character traits, rather than experience.

If none of these work for you, and you dream of adopting a more creative approach that makes a difference, the combination (or hybrid) resume format is exactly what you’re looking for. It allows you to focus on both your experience and your skills, making it a ‘best of both worlds’ format. It’s also suitable for those who want to spice things up by adding different creative sections (e.g. ‘life philosophy’ or ‘what my day looks like’).

Here are some more things worth remembering when it comes to formatting your Regulatory Affairs resume:

Tired of getting rejected? Check out this article on how to craft a resume that stands out!

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