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Sr. Associate Regulatory Affairs

Amgen·Hyderabad

Pay not statedMid levelFull-time
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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
  • Any graduate

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