Forum Sanghvi
Senior Regulatory Affairs Professional | Rare Diseases Orphan Drug Development | Early-Stage to Post-Marketing
- Role
- Senior Director, Global Regulatory Strategy Lead at PepGen
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
ScienceView LinkedIn profile
Experience
Senior Director, Global Regulatory Strategy Lead
Sep 2025 — Present
Education
Mumbai Educational Trust
Bachelor's Degree, Pharmacy
2005 — 2009
Northeastern University College of Professional Studies
Masters, Master of Science in Regulatory Affairs for Drugs, Biologics and Medical Devices
2010 — 2012
Skills
- Amendments and Supplements
- Pharmaceutics
- Clinical Trials
- Spl
- Ectd
- Global Regulatory Compliance
- Global Cmc Submissions
- Regulatory Affairs
- Pma
- Gmp
- Regulatory Submissions
- Annual Reports
- Regulatory Documentation
- Medical Devices
- Ide
- Labeling
- Electronic Common Technical Document (Ectd)
- Ind
- Pharmaceutical Industry
- Sop
- Fda
- Regulatory Strategy Development
- 510k
- Technical Files
- Anda
- Biotechnology
- Ce Marking
- Drug Development
- Biopharmaceuticals
- Nda
- Bla
- Pharmacology
- Title 21 Code of Federal Regulations
- Cmc Regulatory Affairs
- U.s. Food and Drug Administration (Fda)
- Fda Guidance Documents
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