Bharath Kumar N
Senior Manager, GRAAS Operations @ Amgen | Ex. Pfizer | Ex. Parexel | Regulatory Operations
- Role
- Senior Manager, Graas Operations at Amgen India
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Bharath Kumar N
As Senior Team Lead in Submissions Management at Pfizer, my focus is on maintaining the integrity of our pharmaceutical portfolio, ensuring compliance and managing the lifecycle of critical submissions, including the COVID-19 vaccine. With proficiency in CMC systems, our team adeptly handles queries, change management, and submission document compliance, which are vital to the success of our product lines.My role involves the strategic planning of eCTD submissions, lifecycle management of drug products, and oversight of pre- and post-publishing activities to guarantee high-quality submissions. Thanks to robust attention to detail and a strong technical understanding, we contribute effectively to Pfizer\'s mission of delivering breakthroughs that change patients\' lives, while navigating the complexities of regulatory operations with finesse.
Experience
Senior Manager, Graas Operations
May 2025 — Present · Hyderabad, IN
Education
M.S.Ramaiah College of Pharmacy
Master of Pharmacy, Pharmaceutics
2010 — 2012
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