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Director or Senior Director, Regulatory Affairs

Kymera Therapeutics

Kymera Therapeutics seeks a Director or Senior Director of Regulatory Affairs to lead global regulatory strategy for its IRF5 degrader program across multiple immunology and inflammation indications. The role involves managing regulatory filings, leading cross-functional teams, and mentoring junior staff while advancing a novel targeted protein degradation therapeutic.

Responsibilities

  • Develop and drive global regulatory strategy for IRF5 degrader program across immunology and inflammation indications
  • Lead regulatory filings and health authority interactions including INDs, CTAs, IMPDs, and briefing packages
  • Serve as primary regulatory partner collaborating with clinical, CMC, nonclinical, quality, and commercial teams
  • Manage junior regulatory staff through coaching, mentoring, and professional development
  • Monitor regulatory intelligence and emerging guidance to advise on program and business impact

Requirements

  • Bachelor's degree in scientific discipline; advanced degree preferred
  • 8–10 years regulatory affairs experience for Director level; 10–12+ years for Senior Director
  • Demonstrated regulatory lead role with substantial marketing application contribution and approval
  • Proven ability to drive cross-functional teams toward critical program milestones
  • Experience in rheumatology, GI, or immunology/inflammation disease indications strongly preferred
Vacancy posted 7 days ago
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