Karin Pihel
- Role
- Senior Director, Regulatory Affairs at Sumitomo Pharma America, Inc.
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
Manufacturing & ProductionView LinkedIn profile
About Karin Pihel
Regulatory Affairs Certified (RAC) Proficient in the following: • Product…
Experience
Senior Director, Regulatory Affairs
Jul 2023 — Present
Regulatory lead for RETHYMIC, a commercial tissue-based regenerative medicine • Led Agency regulatory interactions to advance RETHYMIC initiatives, including addition of a new manufacturing facility • Wrote and edited sections of regulatory submissions
Education
The University of North Carolina at Chapel Hill
Ph.D., Chemistry
1991 — 1996
Rensselaer Polytechnic Institute
B.S., Chemical Engineering
1987 — 1991
Skills
- Cmc
- V&V
- Cgmp
- Quality Assurance
- Vaccines
- Chemical Engineering
- Fda
- Biotechnology
- Clinical Diagnostics
- Medical Devices
- Drug Development
- Biologics
- Biological Products
- Ich Guidelines
- Medical Diagnostics
- Chemistry
- Validation
- Pharmaceutical Industry
- Quality System
- Gmp
- Quality Systems
- Regulatory Affairs
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