Co-Founder and Board Member @ (May 2024 - Present)
Supervisory Board @ aidCure AG (October 2023 - Present)
VP, Head of Global RA (Major downsizing of the entire organization-Formerly Freeline Therapeutics) @ (March 2022 - December 2022)
Vice President Global Regulatory Affairs @ (January 2020 - January 2022)
Interim VP of Global Regulatory Affairs - Jan-Sept 2020 @ (January 2017 - January 2020)
Head of Regulatory Affairs, PAL (Products and Resources Reallocated and Sold to Purdue Pharma) @ (January 2015 - January 2017)
Global Head of A and L Regulatory Affairs - (Acquired by Shire - position relocated to Lexington, MA) @ (January 2013 - January 2015)
Director Regulatory Affairs @ (January 2007 - January 2013)
Assoc. Director Regulatory Affairs @ (January 2000 - January 2007)
Global CMC Regulatory Affairs @ (January 1998 - January 2000)
Alpesh Patel Education
University of Phoenix
MBA (Marketing)
Long Island University
Alpesh Patel Skills
21 CFR Part 11
Advertising
Biologics
Biopharmaceuticals
Biotechnology
Business Development
CAPA
CMC
CRO
CTMS
Clinical Development
Clinical Operations
Clinical Trials
Communication
Development Of Promotional Materials
Diabetes
Drug Development
FDA
GCP
GLP
GMP
Generic Programming
Good Laboratory Practice (GLP)
IND
Infectious Diseases
Leadership
Management
Market Access
Marketing
Medical Affairs
Medical Writing
NDA
Oncology
Pharmaceutical Industry
Pharmaceutics
Pharmacovigilance
Regulations
Regulatory Affairs
Regulatory Compliance
Regulatory Filings
Regulatory Intelligence
Regulatory Requirements
Regulatory Risk
Regulatory Submissions
SOP
Therapeutic Areas
U.S. Food and Drug Administration (FDA)
Vaccines
eCTD
Public Speaking
Troubleshooting
Good Laboratory Practice Glp
Microsoft Office
Promo
u.s. Food and Drug Administration Fda
u.s. Food and Drug Administration
Good Laboratory Practice
Alpesh Patel Summary
Alpesh Patel, based in Princeton, NJ, US, is currently a Senior Vice President, Regulatory Affairs and Quality at BioTissue. Alpesh Patel brings experience from previous roles at BioTissue, Ardanza BioPharma and aidCure AG. Alpesh Patel holds a MBA in Marketing @ University of Phoenix. With a robust skill set that includes 21 CFR Part 11, Advertising, Biologics, Biopharmaceuticals, Biotechnology and more. Alpesh Patel has 4 emails and 1 mobile phone numbers on RocketReach.
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