Debasisha Samantara
Regulatory Affairs Associate || M.pharm
- Role
- Glos (Freyr) at MSD
- Location
- Hyderabad, IN
- LinkedIn followers
- 500 followers
About Debasisha Samantara
Regulatory Submission and Labeling
Experience
Glos (Freyr)
Jul 2022 — Present · Hyderabad, IN
NDA Submission to the Health Authority USFDA.* BLA Submission to the Health Authority USFDA.* SPL Processing and auditing which will publish to the dailymed (For PAS, AR, CBE0, & CBE 30).*Update/Review activities of EU response documents (for Type IA, Type IAIN, Type IB, & Type II variations) for CP/MRP/DCP procedures to ensure they comply with the guidelines of EMA.*Update/review of HQ documents (CCDS & CCPPI) as per current style guide.*Update/review of core US/EU documents to ensure that they are aligned with HA requirements.*Creating & Updating US, EU, WHO & PAHO Artworks including Product Literature & Packaging components via AMS.* Update/ review of Current circular notification.* Update of Brand development review.*Monitor and Update the document repository with latest approved Labeling.*Update/review of FDA approval letters, client response & final cumulative documents for filling to comply with SRPI, PLR & PLLR guidelines.
Education
Biju Patnaik University of Technology, Odisha
M.pharm
Biju Patnaik University of Technology, Odisha
B.pharm
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