Dilip Kumar Mahapatra
Associate Director, Global Regulatory Affairs at AstraZeneca
- Role
- Associate Director Global Regulatory Affairs at AstraZeneca
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Dilip Kumar Mahapatra
Individual with more than 7 years of experience in pharmaceutical industry with specialization in regulatory affairs for ensuring appropriate licensing, marketing and legal compliance of pharmaceutical products including various NCEs, and Generics. Currently associated with Novartis Health Care Pvt Ltd, Hyderabad, India as a Regulatory Specialist in International Market. Coordination of regulatory activities between source contact & RA affiliates to ensure availability of the new registration, Renewals and variation dossier/additional data and find appropriate ways to facilitate and speed product registration. Ability to understand the patent system and find ways for early filing of dossier to enable FTF. Ability to provide input, guidance and recommendation in the preparation of dossier to give uniformity of filing.
Experience
Associate Director Global Regulatory Affairs
May 2022 — Present · Bengaluru, IN
Regulatory Affairs Management- Global Labelling Management- Dossier Management- IVDR submission
Education
WIPO-UNIGE Summer School on Intellectual Property
General Course on Intellectual Property Rights
2010
Regulatory Affairs Professionals Society | RAPS
Certificate course on Pharmaceutical US & EU regulations
2011 — 2012
Manipal Academy of Higher Education
Master of Pharmacy (M.Pharm), Pharmaceutical Sciences
2004 — 2006
Utkal University
Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Sciences
1999 — 2004
National Academy of Legal Studies & Research (NALSAR) University Hyderabad
PGDPL, PG Diploma in Patent Law
2007 — 2008
Massachusetts College of Pharmacy and Health Sciences
MS-Master of Science, Regulatory Affairs and Health Policy; Massachusetts, USA
2016 — 2018
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