Akshata Udas
Analyst Global Regulatory Affairs at Apotex
- Role
- Analyst at Apotex Inc.
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Akshata Udas
A dedicated and motivated regulatory professional with experience in Drug regulatory affairs. Adept at QMS Trackwise, QMS RIMS, BLUE, DocuBridge, SAP and ESG Gateway. Proficient in eCTD submission, Submission content plan, Submission Delivery/ coordination.
Experience
Analyst
Jun 2024 — Present · Mumbai, IN
In this regulatory role, I manage eCTD and NDS, ANDS submissions, PM updates, Clarifax, and Level filings in compliance with Health Canada guidelines. I compile key regulatory documents, including Product Monographs and Prescribing Information, while coordinating with the Pharmacovigilance team for safety content. I collaborate with design teams to develop compliant artwork—labels, inserts, and cartons—and initiate Change Control Records (CCRs) for post-launch and tech transfer. I lead and coordinate submission planning meetings and support French labeling translations using the Welocalize Portal. My work ensures timely, accurate, and compliant submissions that support product lifecycle management and Canadian market access.
Education
Biocon Academy
Biocon JSS AHER Certificate Program in Global Regulatory Affairs, Regulatory affairs
Sinhgad Technical Education Societys Sinhgad Institute of Pharmacy, Pune Mumbai Bypass Highway, Narhe Ambegaon,Dist.Pune 41
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences
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