New · posted Oct 15
Kardigan · Pharmaceuticals
Senior Director, CMC Regulatory
- Princeton, NJ
- Hybrid
- Full-time
- Director
Open until filled
The role
Kardigan is seeking a Senior Director, CMC Regulatory to support Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases closer to the cures they deserve. The Senior Director will be responsible for leading CMC Regulatory activities to help advance Kardigan’s late-stage clinical assets through clinical development and towards marketing approval. We are looking for a highly motivated individual who will help define CMC Regulatory strategies and successfully execute them in submissions and health authority interactions, in close collaboration with cross-functional partners. This position will report to the Head of CMC Regulatory.
Position Title: Senior Director, CMC Regulatory
Reports To: Head of CMC Regulatory
What you need
Qualifications and Preferred Skillsnice to have
- Bachelor’s degree in scientific discipline required, advanced degree in Chemistry preferred
- 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
- Prior small molecule experience preferred
- Excellent knowledge of FDA, EMA and ICH regulatory guidelines and regulations
- Collaborate and communicate well with all levels of employees, including peers, executives and cross-functionally
- Strong interpersonal, communication (oral and written), and organizational skills
- Ability to handle and prioritize multiple assignments, and work in a fast-paced environment.
Exact Compensation may vary based on skills, experience and location.
What you'll do
- Lead the development and execution of CMC regulatory strategies, working in close collaboration with cross-functional teams to ensure regulatory strategies are aligned with program objectives and timelines
- Proactively manage regulatory CMC aspects of programs to ensure on-time delivery of global, high-quality submissions across all development-stage programs
- Manage regulatory interactions with global health authorities, including meeting preparation and participation, responses to questions, and negotiations.
- Provide regulatory expertise on CMC strategies to cross-functional teams, anticipating regulatory concerns, and proposing innovative solutions.
- Ensure compliance with relevant global CMC requirements (FDA, EMA, and ICH guidelines), and proactively monitor regulatory trends, guidance documents and changes to existing regulations.
- Evaluates proposed manufacturing and quality changes for impact to ongoing and existing submissions and provides strategic regulatory guidance for optimal implementation of changes.
- Help develop and implement department practices, policies, processes, and SOPs
- Manage internal or external staff as needed
Pay
$241,000 – $300,000 a year
Employer provided$241,000—$300,000 USD
Where you'll work
Princeton, NJHybridOpen in Maps (opens in a new tab)
More jobs in Princeton, NJWorking conditions
Department: Regulatory Affairs
From the posting
About Kardigan
Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world.
It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.
Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.
We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.
At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.
These values are the foundation of our work, empowering us to make a real difference, every day.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 29% above the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Director roles in the US43 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $241,000 | — | $300,000 |
| All US (middle half) | $190,500 | $210,000 | $244,500 |
This role: Kardigan's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 82 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Kardigan's own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership6
- Documentation and SOPs5
- Regulatory submissions5
- GMP and compliance2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
Company hiring pulse
Kardigan on Regulatory Jobs
- 4
- Open roles
- 3
- Distinct roles
- 2
- Locations
By discipline
- Regulatory3 75%
- Quality1 25%
By level
- Director4 100%
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Senior Director, CMC Regulatory at Kardigan
Open until filled. $241K–$300K a year, employer provided.