Senior Director, CMC Regulatory
Kardigan · South San Francisco, California, United States
Posted 21 days ago
or apply directly on Kardigan's site. We never take the application ourselves.
Is this posting real?
- This role has been open
- 21 days Kardigan's roles stay open a median of 45 days
- Reposted
- No
- Salary listed
- No 0% of Kardigan's roles list one
- Ghost-job risk at Kardigan
- high 22 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
- 2026-09-17
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 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.
- 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 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
Worth weighing
- 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
Summarised from Kardigan's posting. Read the full original.
Listed by Kardigan on their greenhouse job board, last confirmed open on 2026-09-17. PitchMeAI is not the employer.
More roles at Kardigan
- Head of Medical AffairsPrinceton New Jersey
- Senior Director, CMC RegulatoryPrinceton, New Jersey, United States
- Director, Clinical Trial Liaison WestUnited States
- Sr. Executive Assistant - Contract to HireSouth San Francisco
- Scientist, Drug Metabolism and Pharmacokinetics (DMPK)South San Francisco, California, United States
- Director, Demand/Supply PlanningSouth San Francisco, California