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Kardigan

Senior Director, CMC Regulatory

Kardigan · Princeton, New Jersey, United States

Posted about 2 months ago

or apply directly on Kardigan's site. We never take the application ourselves.

Is this posting real?

This role has been open
59 days
Kardigan's roles stay open a median of 83 days
Reposted
No
Salary listed
No
0% of Kardigan's roles list one
Ghost-job risk at Kardigan
high
38 stale, 4 reposted of 38 open
Hiring momentum
54 roles opened in the last 90 days
↑ up vs. the prior 90 days
Last confirmed on the employer's board
2026-10-25

Measured from postings appearing on and disappearing from Kardigan's own greenhouse board since 2026-08-03. Full hiring picture for Kardigan.

About this role

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.

Our read on this posting2.8out of 5
benefits
1/5
freshness
4/5
career value
4/5
role clarity
5/5
pay transparency
0/5

Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Kardigan as an employer.

What you need

  • 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

Worth weighing

  • 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

Summarised from Kardigan's posting. Read the full original.

Listed by Kardigan on their greenhouse job board, last confirmed open on 2026-10-25. PitchMeAI is not the employer.

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