Shakun Kumar
DIRECTOR REGULATORY AFFAIRS
- Role
- Director Regulatory Affairs at ADVANZ PHARMA
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
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About Shakun Kumar
17 years of experience in Regulatory Affairs with wide experience in various regulated…
Experience
Director Regulatory Affairs
Jul 2025 — Present · Mumbai, IN
Education
Punjabi University
Master's degree, Pharmaceutical Sciences
Welingkar Institute of Management
PGDBM, International Business
2018 — 2020
Hindu College of Pharmacy
Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Sciences
Skills
- Regulatory Requirements
- Pharmaceutical Industry
- Fda
- Regulatory Strategy Development
- Quality System
- Product Lifecycle Management
- Pharmacovigilance
- Gmp
- Quality Management System
- Technology Transfer
- Abbreviated New Drug Application (Anda)
- Dissolution
- Trackwise
- Life Cycle Cost Analysis
- Ectd
- Global Regulatory Compliance
- Research
- Generic Programming
- U.s. Food and Drug Administration (Fda)
- Clinical Trials
- Electronic Common Technical Document (Ectd)
- Global Regulatory Affairs
- Regulatory Affairs
- Anda
- Regulatory Budgeting
- Validation
- Business Enabler
- Regulatory Submissions
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