Senior Director, CMC Regulatory

Kardigan • Princeton, NJ

11h • $241,000 - $300,000 • Onsite

About The Position

Kardigan is seeking a Senior Director, CMC Regulatory, in its Regulatory Affairs department to lead CMC regulatory activities for late-stage clinical assets, supporting their progression through clinical development and toward marketing approval. The role will define and execute CMC regulatory strategies for submissions and health authority interactions in close collaboration with cross-functional partners, ensuring strategies align with program objectives and timelines. The position is based onsite in Princeton, New Jersey, four days per week, and reports to the Head of CMC Regulatory.

Requirements

• Bachelor’s degree in a scientific discipline.
• At least 10 years of industry experience, with most experience in CMC Regulatory Affairs or related roles.
• Experience with global early- and late-phase submissions, including IND/IMPD and NDA/MAA submissions, amendments, and annual reports.
• Experience with health authority interactions.
• Excellent knowledge of FDA, EMA, and ICH regulatory guidelines and regulations.
• Ability to collaborate and communicate with employees at all levels, including peers, executives, and cross-functional partners.
• Strong interpersonal, oral and written communication, and organizational skills.
• Ability to handle and prioritize multiple assignments in a fast-paced environment.

Nice To Haves

• Advanced degree in Chemistry.
• Prior small molecule experience.

Responsibilities

• Lead the development and execution of CMC regulatory strategies in collaboration with cross-functional teams, ensuring alignment with program objectives and timelines.
• Proactively manage regulatory CMC aspects of programs to ensure timely delivery of global, high-quality submissions across development-stage programs.
• Manage global health authority interactions, including meeting preparation and participation, responses to questions, and negotiations.
• Provide CMC regulatory expertise to cross-functional teams, anticipate regulatory concerns, and propose solutions.
• Ensure compliance with global CMC requirements, including FDA, EMA, and ICH guidelines, and monitor regulatory trends, guidance documents, and changes to regulations.
• Evaluate proposed manufacturing and quality changes for their impact on ongoing and existing submissions and provide strategic regulatory guidance for implementing changes.
• Help develop and implement department practices, policies, processes, and SOPs.
• Manage internal or external staff as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior