Shalav Kela
Manager | Global Regulatory Affairs Strategist
- Role
- Manager - Global Regulatory Affairs Strategist at 辉瑞
- Location
- Franklin Park, NJ, US
- LinkedIn followers
- 500 followers
About Shalav Kela
As a Manager of Global Regulatory Affairs at Pfizer, I lead the regulatory strategy and submission activities for complex drug-device combination products, such as inhalers, nasal sprays, and injectables. I have over 12 years of hands-on experience in the regulatory industry, with a strong educational background in pharmacy, pharmacy administration, and health care management.I work with cross-functional teams, including CMOs, to ensure the quality, compliance, and timely delivery of regulatory submissions, such as NDA, IND, IMPD, amendments, supplements, and annual reports. I also participate in the development and implementation of regulatory assessments, change controls, verification and validation activities, technical reviews, and submission peer reviews. I have a proven track record of handling multiple projects from initiation to submission phase and throughout the product life cycle. My mission is to facilitate the approval and launch of innovative and safe products that improve the health and well-being of patients worldwide.
Experience
Manager - Global Regulatory Affairs Strategist
Sep 2022 — Present · Peapack - Gladstone, NJ, US
Education
Sinhgad College of Pharmacy, Pune
Bachelor of Pharmacy (B.Pharm.), Pharmacy
Long Island University
Master of Science (M.S.), Pharmacy Administration and Pharmacy Policy and Regulatory Affairs
Nirma University
Master of Pharmacy (M.Pharm), Pharmaceutical Analysis
Goldey-Beacom College
Master of Business Administration - MBA, Health/Health Care Administration/Management
Skills
- Quality Assurance
- Anda
- Validation
- Abbreviated New Drug Application (Anda)
- Uv
- Electronic Common Technical Document (Ectd)
- 21 Cfr Part 11
- Fda Labeling
- Generic Programming
- Standard Operating Procedure (Sop)
- Hplc
- Drug Delivery
- Regulatory Affairs
- Microsoft Excel
- Regulatory Submissions
- Regulatory Compliance
- Pharmaceutical Industry
- Fda
- Pharmacovigilance
- High-Performance Liquid Chromatography (Hplc)
- Quality Control
- Gmp
- U.s. Food and Drug Administration (Fda)
- Documentation
- Bioequivalence
- Pharmaceutics
- Generics
- Dissolution Testing
- Regulatory Requirements
- Software Documentation
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