Senior Director, CMC Regulatory

Posted yesterday

kardiganSouth San Francisco (CA)

Regulatory Affairs Managers Research and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Manager

SALARY

$248,000 per year

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About the role

About Us: 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 closer 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 inbeing 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 aneagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed towinning as a teamwith urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive toenable the impossiblebecause 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.

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 SOPsManage 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.
Pay range $248,000 - $310,000 USD

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