Cover letter for a regulatory affairs position(5 samples)

This blog post will show samples of “cover letters for a regulatory affairs position.”

How to write a cover letter for a regulatory affairs position

To get a regulatory affairs position, you need a well-written cover letter that showcases your passion for and dedication to the industry. When writing a cover letter for a regulatory affairs position, these are some of the essential things to include in your letter:

  • Address the employer with a formal salutation. For example, “Dear/Hello (name of the recipient or hiring manager).”
  • The next step is to state the position you are applying for and how you found the opening. 
  • Write a short sentence about why you’re interested in the position.
  • State your skills and work experience; ensure they are similar to the job position. When stating your skills, provide the accomplishment you have achieved. 
  • Conclude your letter with a forward-looking statement. For example, “I look forward to discussing the position further.”

Sample 1: “Cover letters for a regulatory affairs position”

“Breanna Wallace

City, State, Zip Code

Home : 000-000-0000 Cell: 000-000-0000

Dear Ms. Schwartz,

I came across your notice on for a Regulatory Affairs Associate with MacProductions Foods Unlimited. I am submitting my resume. I strongly feel my experiences and education puts me high on the list of potential applicants.

My Master’s in Food Science led to three years working in an FDA regulated industry. I maintained direct and daily contact with a number of FDA representatives. My responsibilities also included interaction with disciplinary groups for developing and registering marketing strategies. I am quite knowledgeable in FDA policies and regulations. Well versed in the guidelines of perishables I know the best ways to implement safe strategies that adhere to FDA standards.

My strengths as a regulatory affairs associate would enhance every operation at MacProductions. I would ensure everything was done the right way in the most cost effective manner. I keep up with the governing bodies to stay abreast of the latest trends and where necessary integrate them into current operations as seamlessly as possible. I know my experiences and background would be of great benefit to MacProductions.

I would be happy to come in for an interview to discuss the Regulatory Affairs Associate position more. We can discuss details that began formulating the moment I read your ad.I look forward to hearing from you.

Best Regards,

Breanna Wallace”

Sample 2: “Cover letters for a regulatory affairs position”

“Dear Ms. Bertha Manhart,

I have recently seen your notice regarding an opening for a regulatory affairs associate at your company Fougera Pharmaceuticals Inc. and would like to be considered for the position.

I currently hold a master’s degree in biology and have two years of experience working an FDA regulated industry. I am fully versed in all aspects of FDA regulations and policies regarding all medical devices and understand the guidance that is used for these regulations. I can collaborate and interact with many different disciplinary groups to develop and register marketing strategies for any project.

I am able to conduct research for regulatory need and can allocate the affairs along with submitting advertising proposals and any promotions the client requires. In order to do this, I always keep up with the latest trends and merge all new requirements for each department. I have great communication skills which enables me to offer large or small meetings to ensure that all department heads know and understand these trends.

My strengths lie in enhancing the trends and activities to come up with reengineered projects in order to give our clients the highest quality products. I am also able to submit annual reports and any control documents that are required by the FDA. In order to do this I will always make sure that each department submits their data by the timelines that are set.

You can reach me at any time by calling (555)-555-5555 to set up an interview. I look forward to hearing from you.



Casey Rutledge

Encl: Resume”

Sample 3: “Cover letters for a regulatory affairs position”

“Dear Casey Huel,

Please consider me for the regulatory affairs associate opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for guidance to project teams to ensure compliance with applicable FDA regulations and guidelines.

Please consider my experience and qualifications for this position:

  • Possess interpersonal and organizational savvy
  • Understanding of the pharmaceutical industry, clinical trial processes, and GxP
  • Able to deal effectively with all levels of the organization
  • Self-starting with outstanding work ethic
  • Aptitude for eCOA, electronic source data, data handling, and data privacy principles
  • Fluency in English along with the local language
  • Previous experience in Regulatory Affairs and Clinical Research Experience in clinical study start-up
  • He/She has worked already in an international environment or CRO

Thank you for considering me to become a member of your team.


Rory Wyman”

Sample 4: “Cover letters for a regulatory affairs position”

“Dear Lennon Lang,

In response to your job posting for regulatory affairs associate, I am including this letter and my resume for your review.

In the previous role, I was responsible for assistance and support to Principal Investigators, for timely and accurate submissions of annual reports or other regulatory documents required by the FDA.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

  • IND Amendments and Annual Reports
  • Provide CMC Regulatory support as needed for the authoring/co-authoring/review of documents related to all OTC drugs marketed in the US under the FDA Monographs
  • Attend meetings for assigned projects, as needed, to provide Regulatory perspective/oversight and ensure products are developed and manufactured in accordance with cGMP and all applicable US regulations
  • Collaborate with R&D and other cross-functional partners to support compliant execution of change management via the review of CMC-related change documentation
  • Assess and communicate potential CMC Regulatory risks to products and/or projects and propose mitigation strategies
  • Deliver all CMC Regulatory milestones for assigned products across the product lifecycle
  • Identify, communicate and escalate potential CMC Regulatory issues to Regulatory Management, as needed
  • Monitor the US Regulatory environment, gather any CMC-related technical information and work with the CMC Regulatory Manager/US Regulatory client procedures

Thank you for considering me to become a member of your team.


Onyx Wilderman”

Sample 5: “Cover letters for a regulatory affairs position”

“Dear Azariah Cummerata,

I submit this application to express my sincere interest in the regulatory affairs associate position.

In my previous role, I was responsible for expert review of FDA submissions, design dossiers, technical files, post market submissions, and other regulatory documents.

Please consider my qualifications and experience:

  • Employment or general knowledge of regulatory issues and governmental practices preferred
  • Team player – able to coordinate effectively in a team-oriented environment
  • Self-starter – takes initiative to solve problems and make decisions
  • Broad knowledge of regulatory and healthcare registration systems
  • Participate in industry association meetings
  • Act as a sparring partner for marketing to ensure regulatory compliance
  • Knowledge of Microsoft Office applications and Acrobat Professional
  • Experience in health software or medical device industry

Thank you in advance for taking the time to read my cover letter and to review my resume.


Shiloh Bruen”

Frequently Asked Questions: How to write a cover letter for a regulatory affairs position

How do I write a cover letter for an associate job?

Tips for using your cover letter to stand out

  • Make it personal. 
  • Prioritize the positive. 
  • Get to the point. 
  • Set the right tone.
  • Proofread.

How do I write a cover letter for a work-from-home job?

How to write a work-from-home cover letter:

  • State why you want to work at that law firm.
  • Highlight why you’re a good fit.
  • Ending the law covering letter with a thank you and looking forward a message.

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Regulatory Affairs Manager Cover Letter Examples & Writing Tips

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