Parita Varma
Director Regulatory Cell Therapy/ Biologics - CMC
- Role
- Director Regulatory Affairs - Cmc at Vericel® Corporation
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Parita Varma
Regulatory Affairs professional with a genuine desire to achieve, excel and evolve. Have worked on Modules 1-5. Have worked with publishing, operations and CMC. Accustomed to FDA and EMA regulations. Well versed in all aspects of data handling and compiling. Enjoy working as team player as well as independently. Combine patience and determination to solve problems. Goal-oriented and result-driven. Able to prioritize and operate proactively.
Experience
Director Regulatory Affairs - Cmc
Mar 2025 — Present · Boston, MA, US
Education
Gujarat Forensic Sciences University
M. Pharm, Pharmaceutical Analysis
2010 — 2012
Northeastern University
Master's Degree, Regulatory Affairs in Drugs, Biologics and Medical Devices
2014 — 2016
Savitribai Phule Pune University
Bachelor of Pharmacy (B.Pharm.)
2006 — 2010
Skills
- Preparation and Submission of Dossier and Variation in Ctd Format & Nees Format
- Life Sciences
- Quality Assurance
- Biotechnology
- Regulatory Submissions
- Eursvalidator
- Fda Gmp
- Sap
- Management
- Anda
- Extedo Ectd Manager
- Goose Artwork Manager
- Regulatory Requirements
- Pharmacovigilance
- Quality Control
- Gmp
- Renewals
- Ctd
- Microsoft Office
- Regulatory Compliance
- Windows
- Formulation
- Andas
- Regulatory Affairs
- Sop
- Fda
- Clinical Trials
- Variations
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