Pratiksha Wavale
USFDA_EU DRA_Global Drug regulatory affairs_Abbott
- Role
- Regulatory Affairs Manager at Abbott
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Pratiksha Wavale
Seeking challenging assignments in an organization of good repute which provides me…
Experience
Regulatory Affairs Manager
Sep 2023 — Present · Mumbai, IN
Regulatory affairs expert with 8+ years experience covering several roles such as CMC, Clinical -Non clinical, Process set up, Project management. knowledge of CTA/IND, MAA, NDA/ANDA of small and large molecules products in therapeutic areas such as Oncology, CNS, Respiratory.
Education
University of Mumbai
Bsc biotechnology, Biotechnology
2010 — 2013
IPM academy
Regulatory affairs for API and formulation, Regulatory submissions for DMF,ASMF,CEP,ANDA,MAA
2018 — 2019
Sophia Girls College
PGD in QA for food and pharamaceutical industry, Post graduation in quality assurance in food and pharamaceutical industry management
2013 — 2015
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