Regulatory Affairs Manager
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Resume samples
Magnolia Thimmesch
magnolia.thimmesch@gmail.com | (367) 741-8850 | Maple Grove, MN
Summary
I am a Regulatory Affairs Manager with over 5 years of experience in the medical device industry. I have a strong background in regulatory compliance and have successfully managed projects from start to finish. I am an expert at developing and implementing strategies to ensure compliance with regulations, as well as preparing for and responding to audits. I also have experience conducting training on regulatory requirements and procedures.
Experience
Regulatory Affairs Manager at 3M, MNMar 2022 - Present
- Led a team of 4 regulatory affairs specialists in preparing and submitting 5 IND applications to the FDA within 6 months, resulting in approval for all 5 clinical trials.
- Wrote or contributed to 10 SOPs related to regulatory affairs procedures and processes.
- Reviewed 100% of marketing collateral for compliance with FDA regulations prior to release.
- Trained 20 new employees on FDA regulations relevant to their job duties.
- Submitted 15 amendments/supplements/annual reports to the FDA without any major deficiencies cited by the agency during review.
Regulatory Affairs Specialist at Mayo Clinic, MNAug 2017 - Mar 2022
- Negotiated and obtained approval from the FDA for a new drug within 6 months of starting at the company.
- Wrote and submitted 3 successful INDs to the FDA in 1 year.
- Successfully navigated 2 NDA submissions through the FDA process, resulting in approvals within 12 months.
- Led a team of 4 Regulatory Affairs Associates in preparing 5 Annual Reports to the FDA.
- Trained 4 new employees on Regulatory Affairs procedures.
Education
Bachelor of Science in Regulatory Affairs at University of MinnesotaSep 2013 - May 2017
I have learned excellent research, writing, and communication skills while studying for my Bachelor of Science in Regulatory Affairs.
Skills
- Regulatory Affairs
- Clinical Trials
- FDA Regulations
- Medical Devices
- Pharmaceuticals
- Biologics
Matalyn Coye
matalyn.coye@gmail.com | (971) 161-3746 | 603 Maple Street, Manchester, NH 03103, USA
Summary
I have over 5 years of experience in Regulatory Affairs and truly enjoy the work that I do. In my previous positions, I was responsible for managing all regulatory aspects of clinical development projects, as well as interacting with global health authorities. My strong communication skills have helped me build positive relationships with both internal and external stakeholders. Additionally, I am very detail-oriented and thrive in fast-paced environments. In my current role as a Regulatory Affairs Manager, I am responsible for overseeing all regulatory activities for our organization
Experience
Regulatory Affairs Manager at Pfizer, NHMay 2022 - Present
- Led the development and implementation of a new regulatory affairs strategy that resulted in a 20% increase in approval rates for submissions.
- Negotiated with FDA on behalf of company to have 3 clinical holds lifted, allowing for resumption of trials and saving $1.5 million in costs.
- Developed and implemented training program for staff on Good Clinical Practices (GCPs), which resulted in 100% compliance with GCPs during audits.
- Wrote successful grant application to NIH resulting in $3 million funding for clinical trial.
- Led team of 4 regulatory associates who submitted 50 IND/IDE applications per year.
Regulatory Affairs Specialist at Sanofi, NHJul 2017 - Apr 2022
- Negotiated and secured approval from the FDA for a new medical device, which increased company revenue by $5 million within the first year of launch.
- Wrote and submitted 50 successful regulatory submissions to various international agencies, resulting in timely approvals for clinical trials and commercialization of products.
- Managed a team of 5 regulatory affairs associates in developing country-specific strategies for product registration and maintenance across 60 countries worldwide.
- Led the development of comprehensive training materials on Good Regulatory Practices (GRP) compliance requirements, reducing audit findings by 80%.
- Successfully completed 10 complex projects with little to no direction while consistently meeting deadlines set forth by clients .
Education
Bachelor of Science in Regulatory Affairs at University of New HampshireAug 2013 - May 2017
I have learned excellent writing, research, and communication skills while studying for my Bachelor of Science in Regulatory Affairs.
Skills
- Regulatory Affairs
- Clinical Trials
- FDA Regulations
- Pharmaceuticals
- Medical Devices
- Quality Assurance
- Compliance