Senior Director, CMC Regulatory

About Us 

Position Title: Senior Director, CMC Regulatory

Department: Regulatory Affairs

Reports To: Head of CMC Regulatory

Location: Princeton, NJ (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.