Full-time

Amgen Inc. is hiring a Regulatory Affairs Manager (CMC)

About the Role

Amgen Inc. is looking for a Regulatory Affairs Manager (CMC) to play a key role in the global regulatory lifecycle of our commercial portfolio. You will be responsible for executing and coordinating Chemistry, Manufacturing, and Controls (CMC) activities to ensure regulatory compliance and strategy implementation.

What You'll Do

  • Execute and coordinate global regulatory CMC activities for assigned commercial products.
  • Provide leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy.
  • Communicate the regulatory strategy, risks, and issues to Regulatory and Operations senior management.
  • Coordinate communication, collaboration, and coordination with site and regional CMC representatives to develop and execute global regulatory activities.

Amgen Inc. is an equal opportunity employer.

Required Skills
Regulatory AffairsCMCBiologicsRegulatory SubmissionsFDAEMAICH GuidelinesQuality SystemsComplianceProject ManagementCommunicationLife SciencesChemistryManufacturingBiotechnology
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About company
Amgen Inc.

Amgen is a biotechnology company that pioneers the world of biotech in the fight against the world’s toughest diseases, with a focus on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease.

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Job Details
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Posted 7 months ago