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← Kardigan

Senior Director, CMC Regulatory

Kardigan
Location
South San Francisco, California, United States
Posted
25 days ago
Department
235 Regulatory
What they actually want (must-haves)
  • Bachelor’s degree in scientific discipline
  • Minimum of 10 years industry experience with majority in CMC Regulatory Affairs or related roles
  • Experience with global early and late phase submissions (IND/IMPD and NDA/MAA, amendments, and annual reports)
  • Excellent knowledge of FDA, EMA and ICH regulatory guidelines and regulations
  • Strong interpersonal, communication (oral and written), and organizational skills
  • Ability to handle and prioritize multiple assignments in a fast-paced environment
Nice to have
  • Advanced degree in Chemistry
  • Prior small molecule experience
What the job really is

The Senior Director, CMC Regulatory at Kardigan will lead the development and execution of regulatory strategies for CMC activities, ensuring alignment with program objectives and timelines. This role involves managing regulatory submissions and interactions with global health authorities, providing expertise on CMC strategies, and ensuring compliance with relevant regulations. The position requires close collaboration with cross-functional teams and may involve managing internal or external staff.

Things to weigh
  • Onsite work required 4 days per week
  • Exact compensation may vary based on skills, experience and location, with a specified pay range of $248,000 — $310,000 USD
Job score2.8/5
Benefits1/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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