HHiring Reality
← Kardigan

Senior Director, CMC Regulatory

Kardigan
Location
Princeton, New Jersey, 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 of experience in CMC Regulatory Affairs or related roles
  • Experience with global early and late phase submissions (IND/IMPD and NDA/MAA, amendments, and annual reports) and health authority interactions
  • 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, and work 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 regulatory activities to advance the company's late-stage clinical assets towards marketing approval. This role involves developing and executing CMC regulatory strategies, managing submissions and health authority interactions, and ensuring compliance with global regulatory requirements. The position requires close collaboration with cross-functional teams and may involve managing internal or external staff.

Things to weigh
  • Onsite requirement of 4 days per week
  • Exact compensation may vary based on skills, experience and location; pay range provided is $241,000 — $300,000 USD
Job score2.8/5
Benefits1/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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