Associate Director, Cmc Regulatory Affairs

Alkermes

Waltham, MA, United States
Base: $172,000 to $187,000; bonus/equity: eligible...
Hybrid
Lead regulatory cmc strategy
Prepare and submit cmc sections
Respond to health authority queries
The Associate Director, Regulatory Affairs CMC will serve as the Regulatory CMC Lead for a late-stage small molecule development program

Job Summary

  • The Associate Director, Regulatory Affairs CMC will serve as the Regulatory CMC Lead for a late-stage small molecule development program.
  • Key responsibilities include leading regulatory CMC strategy and execution, collaborating cross-functionally, and overseeing the preparation and submission of CMC sections for regulatory filings.
  • Alkermes offers a competitive benefits package and has been recognized as an employer of choice.

Matching Summary

The Associate Director, Regulatory Affairs CMC will serve as the Regulatory CMC Lead for a late-stage small molecule development program.

Salary

Base: $172,000 to $187,000; Bonus/Equity: eligible for annual performance pay bonus; Benefits: competitive benefits package

Skills & Requirements

Must-have

  • Lead regulatory CMC strategy
  • Prepare and submit CMC sections
  • Respond to Health Authority queries
  • Develop Health Authority meeting strategies
  • Monitor global CMC regulations

Nice-to-have

  • Strategic excellence and collaborative spirit
  • Continuous improvement and best practices
  • Foster relationships with stakeholders

Key Requirements

  • Bachelor of Science in scientific discipline
  • 7+ years pharmaceutical/biopharmaceutical industry experience
  • 3+ years Regulatory Affairs CMC experience
  • Regulatory CMC lead experience required

Work Rights

Not specified

Tailored Resume

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