Manoj Kumar Gupta
Regulatory CMC Project Lead
- Role
- Regulatory Cmc Manager at Novartis
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Manoj Kumar Gupta
Expertise in Regulatory Submission to EMEA, Health Canada - TPD, TGA, Medsafe and MCC- Having 6 years experience of regulatory activities (product development support, submissions, prost approval regulatory compliance)- Product life cycle management and Regulatory compliance (Strategic planning of variation submissions)- Working experience on Global Change Control processing in Quality Management System TrackWise® - Working experience on regulatory submission software’s like Documentum Compliance Management, Citrix® (eCTDXpress), PharmaReady- Post Graduate in Pharmacy from University of Delhi (DIPSAR, New Delhi)- GATE qualified with 99.68 percentile (All India Rank -88) from IISc Bangalore
Experience
Regulatory Cmc Manager
Apr 2018 — Present · Hyderabad, IN
Education
Delhi University
M Pharm, Pharmacology
2008 — 2010
B N College of Pharmacy, Udaipur
B Pharm, Pharmaceuticals Sciences
2003 — 2007
Skills
- Anda
- Ectd
- Hplc
- Generic Programming
- Standard Operating Procedure (Sop)
- Pharmaceutical Industry
- Sop
- Pharmaceutics
- Excel
- Microsoft Word
- Powerpoint
- Microsoft Excel
- Pharmaceutical Sales
- Pharmacovigilance
- Gmp
- Research
- Regulatory Affairs
- Regulatory Submissions
- Quality System
- Word
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