Akash Patel
Manager, Regulatory Affairs Cmc @AstraZeneca
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WORK HISTORY
Manager, Regulatory Affairs Cmc @AstraZeneca
CA
EDUCATION
Ashish higher secondary school, Ahmedabad
Higher secondary education
Gujarat University
Bachelor of Pharmacy (B.Pharm.), P&M kansara Pharmacy college
National Institute of Pharmaceutical Education and Research
M.S (Pharm.), Biotechnology
ABOUT AKASH PATEL
A Biopharmaceutical professional having 10+ years of experience as regulatory CMC and GxP professional having hands-on expertise on CMC regulatory strategies- In-depth knowledge of CMC regulatory requirements for product life cycle management and new product launch; recognized as CMC expert in biologics and small molecules by global and local matrix teams; knowledge of quality systems and supply chain complexities- Proven ability to communicate and negotiate with US-FDA, EMA, Health Canada and Swissmedic to achieve on-time regulatory approvals- Successfully managed PLCM projects such as manufacturing scale up, technology transfer, change of container closure system, product monograph updates etc. Hands-on experience with analytical method development, validation and testing of biopharmaceuticals- Thorough understanding of pharmaceuticals and biologics - drug development, aseptic manufacturing, sterile filling and commercialization processes- Strong ability to apply and leverage scientific knowledge for the submission preparation and Health authority interactions- Recognized as a strong team-player and trusted partner; effectively facilitate discussions and build trusted relationships in internal and external cross-functional environments.
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