Mohit Khandelwal
Global Regulatory Affairs Leader | Bioloigcs & Synthetics | People Manager | Industry focused AI Leader
- Role
- Associate Director Regulatory Affairs at AstraZeneca
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Mohit Khandelwal
I\'m a Regulatory Affairs Professional with 17+yrs of experience and worked for Global Markets for some of the Pharmaceuticals Global MNCs like Medtronic, Alkem, Sun Pharma erstwhile Ranbaxy, Syneos Health, AZ, Merck Inc, UCB, GE Healthcare, Biocon Ltd, Eli Lilly & Co.Specialties: Technical and People Development Group Leader, Project manager. Regulatory authoring, reviewer/approver, GPT contributor, end to end labeling and artwork management, regulatory gap analysis, negotiation, front end HA partners / customers liaising, planning and planning and executing regulatory strategy, Reg tool development, Veeva Vault expert, market research, team player and team handling.Subject Matter Expert in Global markets product life cycle management and US Annual Reports, RIMS- Veeva Vault
Experience
Associate Director Regulatory Affairs
Aug 2022 — Present · Bengaluru, IN
Education
Eli Lilly and Company
Internal courses
AstraZeneca
Internal training courses and workshops
Jiwaji University Gwalior
B. Pharm, pharmacy
2003 — 2007
Manipal Academy of Higher Education
M.S. Regulatory Affairs, Pharma Regulatory Affairs
2007 — 2009
Skills
- Market Research
- Regulatory Affairs
- Pharmacovigilance
- Gmp
- Quality Assurance
- Pharmaceutical Sales
- Strategy
- Pharmaceutical Industry
- Sop
- Pharmaceutics
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