About Us
Position Title: Senior Director, CMC Regulatory
Department: Regulatory Affairs
Reports To: Head of CMC Regulatory
Location: South San Francisco, CA (onsite 4 days per week)
Job Overview
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.
Essential Duties and Responsibilities
- 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
Qualifications and Preferred Skills
- 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.
Skills Required
- Bachelor's degree in a scientific discipline
- Advanced degree in Chemistry
- Minimum of 10 years of industry experience, primarily in CMC Regulatory Affairs or related roles
- Experience with global early- and late-phase submissions, including IND, IMPD, NDA, MAA, amendments, and annual reports
- Experience with small-molecule products
- Strong knowledge of FDA, EMA, and ICH regulatory guidelines and regulations
- Ability to collaborate and communicate effectively with employees at all levels and cross-functional teams
- Strong interpersonal, oral and written communication, and organizational skills
- Ability to manage and prioritize multiple assignments in a fast-paced environment
Kardigan Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Kardigan and has not been reviewed or approved by Kardigan.
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Healthcare Strength — Comprehensive medical, dental, and vision coverage is paired with life and disability insurance and an EAP, signaling a robust core benefits backbone. Employer materials present this coverage as part of a standard, well-rounded package for a U.S. biotech.
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Fair & Transparent Compensation — Explicit salary ranges are posted for multiple roles and the company highlights competitive salaries, indicating greater pay transparency for candidates. The careers site and job postings also outline an annual bonus program, clarifying elements of total cash compensation.
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Leave & Time Off Breadth — Paid holidays and paid time off are called out, with culture materials referencing “generous” PTO. These signals point to substantive time-off provisions even if accrual details are not yet specified.
Kardigan Insights
What We Do
Kardigan is a patient-driven heart health company that is modernizing cardiovascular drug development to deliver medicines that move patients beyond symptom management to functional cures. By matching critical disease drivers with treatment responders identified in clinical trials, Kardigan is developing a portfolio of medicines that modify the underlying cardiovascular disease pathophysiology to get patients closer to the cures they deserve. For more information about Kardigan, please visit kardigan.bio. If you are interested in joining our passionate and driven team with deep cardiovascular, biotechnology and operational expertise, please visit kardigan.bio or the careers tab of this page.
