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← Kymera Therapeutics

Director or Senior Director, Regulatory CMC

Kymera Therapeutics
Location
Watertown, MA
Posted
1 month ago
Department
Development
Salary
$195,000 – $330,000
What they actually want (must-haves)
  • BS, MS, or PhD in Chemistry, Pharmaceutics, Biochemistry, Chemical Engineering, or a related scientific discipline
  • 10+ years of progressive Regulatory Affairs CMC experience in the biotechnology or pharmaceutical industry
  • Deep experience in late-stage regulatory CMC activities
  • Extensive hands-on small molecule CMC experience
  • Demonstrated success independently authoring, reviewing, and managing CMC content for small molecule INDs/CTAs and marketing applications
  • Strong working knowledge of global CMC regulatory requirements and guidance for small molecule products
What the job really is

In this role, you will lead the development and execution of global regulatory CMC strategies for targeted protein degradation programs, focusing on late-stage development and approval processes. You will collaborate with various teams to ensure alignment of regulatory strategies with program timelines, author and review regulatory submission content, and provide strategic guidance to senior leadership. Additionally, you will oversee external manufacturing partners to ensure compliance and readiness for submissions.

Benefits
  • Competitive compensation package
  • Eligibility for annual bonus
  • Equity participation
  • Comprehensive benefits
Things to weigh
  • Role involves significant responsibility in regulatory strategy and compliance, which may be high-pressure
  • Focus on late-stage activities may limit exposure to early-stage development processes
Job score4/5
Benefits2/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency5/5

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