Poonam Jamwal
Regulatory affairs & business continuity- US & OAM
- Role
- Executive (Regulatory & Business Continuity) at Sun Pharma Advanced Research Company Ltd.
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
Experience
Executive (Regulatory & Business Continuity)
Sun Pharma Advanced Research Company Ltd.
Mar 2024 — Present
Experienced in ANDA submissions for US market across OSD and injectable dosage forms and handling FDA queries including DRL, CRL, and IR responses for ANDA submissions in OSD and injectable projects. Regulatory Affairs professional with 3 years of experience in post-approval regulatory submissions for the US market, specializing in oral solid dosage (OSD) and injectable projects. Proficient in managing ANDA lifecycle activities, including CMC variations, annual reports, labeling updates, and CBE-30, CBE-0, post-approval supplements (PAS). Skilled in PharmaReady and Amplexor software for regulatory document management and eCTD submissions, ensuring FDA compliance and efficient handling of post-approval commitments. Adept at cross-functional collaboration to streamline regulatory workflows.
Education
PIONEER PHARMACY COLLEGE, SAYAJIPURA 235
B.pharma, Pharmacy
The Maharaja Sayajirao University of Baroda
M.pharma, Pharmaceutical chemistry
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