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Regulatory Affairs Associate

Writing a great regulatory affairs associate resume is important because it is one of the first things a potential employer will see when they are considering you for a position. It is your opportunity to make a good first impression and sell yourself as the best candidate for the job.

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If you're looking for inspiration when it comes to drafting your own regulatory affairs associate resume, look no further than the samples below. These resumes will help you highlight your experience and qualifications in the most effective way possible, giving you the best chance of landing the regulatory affairs associate job you're after.

Resume samples

Denee Heckenbach

denee.heckenbach@gmail.com | (202) 677-2731 | Billings, MT

Summary

I have over 1 year of experience working in regulatory affairs. I am responsible for ensuring that products are compliant with all relevant regulations. I have a strong understanding of the regulatory process and how to navigate it effectively. I am able to work independently and take ownership of projects. I am an excellent communicator and have a proven track record of successful interactions with regulators.

Experience

Regulatory Affairs Associate at MCR American Regulatory Affairs, MTApr 2022 - Present

  • Led the development of 3 successful new products, which generated $12 million in sales within the first year.
  • Wrote and implemented 5 company-wide policies that improved compliance with FDA regulations.
  • Trained 10 employees on proper regulatory procedures.
  • Negotiated with FDA officials to get approval for 2 clinical trials.
  • Successfully launched 1 new product in 6 months, ahead of schedule.

Regulatory Affairs Specialist at Regulatory Affairs Professionals Society, MTSep 2021 - Mar 2022

  • Successfully completed 8 regulatory submissions within tight timelines, while ensuring compliance with applicable regulations.
  • Successfully navigated 5 complex projects through the regulatory process.
  • Liaised effectively with cross-functional teams to ensure successful and timely completion of all deliverables.
  • Demonstrated excellent written and verbal communication skills by preparing clear and concise submission documents.
  • Maintained up-to-date knowledge of global regulatory requirements and provided input on potential impact to project plans.
  • Played a key role in developing and implementing new departmental procedures which improved efficiency by 30%.

Education

Bachelor of Science in Regulatory Affairs at Montana State University, Bozeman, MTAug 2016 - May 2021

I have learned excellent research, writing, and communication skills while studying for my degree.

Skills

  • Regulatory Affairs
  • Clinical Trials
  • Good Manufacturing Practices (GMP)
  • Good Laboratory Practices (GLP)
  • 21 CFR Part 11 Compliance
  • Validation and Qualification

Roselyn Gromley

roselyn.gromley@gmail.com | (757) 848-7623 | Charlotte, NC

Summary

I have over 1 year of experience working in regulatory affairs. I am responsible for ensuring that products are compliant with all relevant regulations. I have a strong attention to detail and excellent organizational skills. I am able to work independently and as part of a team.

Experience

Regulatory Affairs Associate at GlaxoSmithKline, NCMay 2022 - Present

  • Negotiated with the FDA on behalf of a pharmaceutical company to get approval for a new drug.
  • Wrote and submitted regulatory filings to the FDA for review.
  • Reviewed clinical trial data and made recommendations to improve study design.
  • Monitored compliance with regulations governing clinical trials.
  • Trained staff on Good Clinical Practices (GCPs).
  • Led development of Standard Operating Procedures (SOPs) for Regulatory Affairs.

Regulatory Affairs Specialist at Novartis, NCSep 2021 - Apr 2022

  • Successfully completed 4 regulatory submissions in 6 months, ahead of schedule.
  • Successfully navigated 3 complex projects through the regulatory approval process with no major delays.
  • Managed a team of 5 Regulatory Affairs Associates and helped train 2 new employees on submission requirements and processes.
  • Worked closely with cross-functional teams to ensure all required information was gathered for submissions.
  • Identified potential risks/issues early on in the development process and worked with project teams to mitigate those risks.
  • Maintained up-to-date knowledge of global regulatory requirements and provided input into product development plans.

Education

Bachelor of Science in Regulatory Affairs at Duke University, NCAug 2017 - May 2021

I have learned how to effectively communicate with different types of regulatory agencies, how to read and interpret scientific and medical literature, and how to write clear and concise regulatory documents.

Skills

  • Medical Terminology
  • FDA Regulations and Guidelines
  • Clinical Trials Management
  • Regulatory Affairs Documentation
  • Electronic Submissions (eCTD)
  • ICH Guidelines

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