ARPIT PATEL
Senior Manager, Regulatory CMC@Biogen
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Summary
Global Regulatory Affairs CMC Lead at Biogen. A highly qualified Pharmacology postgraduate with vast experience in pharmaceutical New Product Development, Quality, Regulatory Affairs and Compliance within Medicinal Products and Medical Devices. Confident with strong scientific knowledge and articulate communicator in a professional manner with ability to conduct impressive presentations to a multi-disciplinary audience. Extremely organised and highly self-motivated, with a proven background in achieving targets and meeting tight deadlines, performing well in a highly pressurised working environment. Possessing excellent interpersonal and liaison skills with the ability to communicate concisely at all levels building and maintaining productive working relationships. Specialities: New Product Development, Regulatory Submission, Dossier Preparations, Data Interpretation,Quality Management, Team work, Strong Communication skills, Knowledge of MS office and Adobe Reader.
Work experience
Senior Manager, Regulatory CMC
Biogen2025.01-Current(2 years)Global Regulatory Affairs CMC Lead
Kenvue2022.01-2025.01(3 years)Associate Regulatory Affairs Director - Oncology
AstraZeneca2021.02-2022.01(a year)Regulatory Affairs Consultant
Parexel2018.07-2021.02(3 years)Regulatory Affairs Manager
MEDICOM HEALTHCARE LIMITED2015.07-2018.07(3 years)Senior Regulatory Affairs Officer
MEDICOM HEALTHCARE LIMITED2013.04-2015.06(2 years)Regulatory Affairs & Quality Assurance Controller
HealthAid Limited, UK2011.06-2013.03(2 years)Medical Counter Assistant
Ritechem Pharmacy, UK2008.06-2009.12(2 years)
Educational experience
University of Hertfordshire
Master of Pharmacology, Life Sciences2010.01-2011.01(a year)M.I.P.S. Ujjain (University of Technology of Madhya Pradesh, INDIA)
Bachelor of Pharmacy, Pharmaceutical2003.01-2007.01(4 years)
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