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Sr. Associate Regulatory Affairs

HyderabadFull-timeMid levelPosted over a month ago

Mid-level pharma role at Amgen in Hyderabad.

About the role

For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. Interact with authors/reviewers and subject matter experts with respect to delivery of CMC and/or Device documents required for regulatory submissions Coordination, preparation, collection and/or legalization of CMC country specific documents

What you'll do

  • Lead submission for annual reports, facility registrations, facility renewals, and product renewals
  • Interact with authors/reviewers and subject matter experts with respect to delivery of CMC and/or Device documents required for regulatory submissions

What you need

  • Regulatory affairs

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