Dr. Ghulam Moinuddin
LRR, Global Regulatory Affairs and Safety (GRAAS)
Biotechnology
AMGEN
India
Biography
Dr. Moin is a Scientific Regulatory Professional with 13 years of extensive Regulatory and 5 years of academic experience, with a track record of providing leadership for Quality-CMC, Non-Clinical and Clinical Regulatory Projects at Amgen, LG Life Sciences; Intas Bio-Pharmaceuticals; Dr. Reddy’s Laboratories (Biologics Division); Biocon and Recon (Zydus). Demonstrated ability to strategize, compile and review regulatory submissions to Health Authorities. Actively participated in New Drug Development; Clinical Trial approvals; Marketing Approvals and commercialization of 2 NBEs; 14 biologics in India; SAARC; RoW; and 1 in Europe. Product Life Cycle management. Efficiently handled queries; regulatory negotiations; Tech Transfer; Due-Diligence, Licensing. Participated in GMP audits by Benchmark Regulatory Agencies and Global Pharmaceutical Companies. Audited GLP Laboratories and Manufacturing facilities. Dr. Moin holds Diploma in Pharmacy; Bachelor’s Degree in Pharmaceutical Sciences; Post Graduate Degree in Pharmacology; and Doctor of Philosophy in Pharmacology (Cardiovascular) from one of India’s top-notch Pharmaceutical Sciences Schools at Al-Ameen College of Pharmacy, Bangalore.
Research Interest
Regulatory Strategy, MAA, IMPD, CTAs, Pre-IND, IND, ANDA, DMFs, CTD Module 1-5, Form-44, PAC.
