Swohinee Sarkar
Regulatory Affairs | Post-Approval Changes & Labeling | USFDA, EMA & Morocco Submissions | Pharmaceutical Industry
- Role
- Regulatory Affairs Specialist at Onesource
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Swohinee Sarkar
Regulatory Affairs professional with an MPharm in Regulatory Affairs from Manipal Academy…
Experience
Regulatory Affairs Specialist
Jun 2025 — Present · Bengaluru, IN
I support global regulatory submissions and compliance for pharmaceutical products, with a focus on the US market. My role includes:• Preparing and reviewing high-quality ANDAs and regulatory dossiers• Ensuring timely submissions for ANDAs, post-approval changes, and control correspondences• Reviewing master documents (e.g, Specifications, MFR, Packing records, and Stability protocols) to meet global market requirements• Using tools like eCTD, Educe, and SPL for regulatory compliance• Monitoring labeling updates and coordinating with cross-functional teams for submission-readiness• Addressing deficiency responses to support first-cycle approvals• Gaining hands-on experience with regulatory guidelines and compliance documentation across sites
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