Priya Chatterjee
Regulatory Affairs
- Role
- Head Regulatory Affairs- South Asia at Bayer
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Priya Chatterjee
Associated with the pharma industry since 1996 in QC & RD. Working for regulatory affairs since 2003.Well-versed with the general SoP as a part of global Regulatory Affairs, general compliance, and conduct of an MNC with the regulatory authorities. Successful in early registration of NDAs across different therapy areas in drugs/devices and biologicals Specialties: Regulatory Strategy and planning: NDA Drug / Device /Biologicals /Food /Consumer Products. CTs Phase II to IV. Have been working with DCGI, FDA, DGFT, ICMR, CDTL, IPC; NIB; CDL, FSSAI New Delhi, and FSSAI zonal offices. Regulatory strategy and planning the path for new product launches are my forte.
Experience
Head Regulatory Affairs- South Asia
Mar 2021 — Present · Mumbai, IN
Education
St. Joseph's Academy, Dehradun
ICSE
1983 — 1989
University of Mumbai
Ph.D, Biotechnology , Biochemistry and Tissue Culture
1997 — 2001
Jai Narain Vyas University; Jodhpur ; India
B.Sc, Chemistry, Botany, Zoology
1991 — 1994
University of Mumbai
Master's degree
1994 — 1996
Cornell University
Executive Program in Management, Business Administration and Management, General
Kendriya Vidyalaya
H Sc, Science
1989 — 1991
Skills
- Regulatory Submissions
- Pharmacovigilance
- Gmp
- Gcp
- Biotechnology
- Regulatory Affairs
- Clinical Development
- Clinical Trials
- Pharmaceutics
- Pharmaceutical Industry
- Sop
- Medical Affairs
- Fda
- Drug Safety
- Clinical Research
- Good Clinical Practice (Gcp)
- Regulatory Requirements
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