Prashant Kumar
Pharma/Medical Devices/Chemicals
- Role
- Senior Global Program Regulatory Manager at Novartis
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
OperationsView LinkedIn profile
About Prashant Kumar
Results-driven Regulatory Affairs Expert with 10.1 years of experience in Drug & Medical…
Experience
Senior Global Program Regulatory Manager
Aug 2024 — Present · Hyderabad, IN
Education
Dayananda Sagar College of Pharmacy,Bangalore
Bachelor of Pharmacy (B.Pharm.), Pharmacy
2005 — 2009
Holy Mission High School
Higher Secondary, Biology/Biological Sciences, General
2001 — 2004
Indian Institute of Technology, Delhi
Certificate Programme , Project Management - Theory and Practice
JSS College of Pharmacy,Ooty
M. Pharmacy, Pharmaceutical Regulatory Affairs
2010 — 2012
Skills
- Change Control
- CRO
- Regulatory Affairs
- Lifesciences
- Contract Management
- Pharmacovigilance
- Quality Control
- Gmp
- Nanotoxicology
- Anda
- Validation
- 21 Cfr Part 11
- Pharmaceuticals
- Regulatory Requirements
- Oncology
- Ind
- Cgmp
- Regulatory Submissions
- Glp
- Medical Writing
- Pharmaceutical Industry
- Sop
- Fda
- Ectd
- Regulatory Strategy
- Process Validation
- Quality Assurance
- Life Sciences
- Clinical Development
- Hplc
- Quality Systems
- Ich-Gcp
- Medico Marketing
- Operations Management
- Drug Development
- Gcp
- Biopharmaceuticals
- Biotechnology
- Technology Transfer
- 510 K
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