
Shailesh Patel
Achievement – driven Regulatory Affairs professional with nearly 13+ years of working experience with leading Organizations. Regulatory expertise... | Greater Ahmedabad Area, Greater Ahmedabad Area, India
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Shailesh Patel’s Emails sh****@ya****.co
Shailesh Patel’s Phone Numbers No phone number available.
Social Media
Shailesh Patel’s Location Greater Ahmedabad Area, Greater Ahmedabad Area, India
Shailesh Patel’s Expertise Achievement – driven Regulatory Affairs professional with nearly 13+ years of working experience with leading Organizations. Regulatory expertise includes Regulatory strategies, Pre-IND & Pre-ANDA meetings, Dossier compilation for ANDAs, MAA, 505(b)(2), Complex Generics, Peptides and Drug-Device Combination Products and Product life cycle management for USA and Europe. I am competent, enthusiastic Regulatory affairs professional, who strives to develop and successfully implement progressive strategies for effectively meeting the challenges of global Regulatory environments. Combined knowledge of Scientific, Regulatory and Business perspectives for products that are developed, manufactured or distributed to meet required Regulatory expectations. Support senior management in planning, evaluation and finalization of Regulatory strategy for pre and post approval of drug products.
Shailesh Patel’s Current Industry Amneal Pharmaceuticals
Shailesh
Patel’s Prior Industry
Zydus Cadila
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Unimark Remedies
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Claris Lifesciences
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Amneal Pharmaceuticals
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Work Experience

Amneal Pharmaceuticals
Sr. Manager - RA
Sat Jan 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Amneal Pharmaceuticals
Manager - RA
Wed Jan 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Amneal Pharmaceuticals
Assistant Manager - RA
Mon Jan 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Amneal Pharmaceuticals
Sr. Executive - RA
Fri Jan 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Amneal Pharmaceuticals
Executive - RA
Sat Feb 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Claris Lifesciences
Jr. Executive -IRA
Sun Apr 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Feb 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Unimark Remedies
RA chemist
Sat Jan 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Feb 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Zydus Cadila
Project Trainee
Sun Nov 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jul 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)