Senior Director, CMC Regulatory

The role

The Senior Director will lead CMC regulatory activities to advance late-stage clinical assets through clinical development and towards marketing approval. This role involves defining and executing CMC regulatory strategies and managing health authority interactions.

What you will do

• Lead the development and execution of CMC regulatory strategies.
• Manage regulatory CMC aspects of programs to ensure on-time delivery of global submissions.
• Manage regulatory interactions with global health authorities.
• Provide regulatory expertise on CMC strategies to cross-functional teams.
• Ensure compliance with relevant global CMC requirements.
• Evaluate proposed manufacturing and quality changes for impact to submissions.
• Help develop and implement department practices, policies, processes, and SOPs.
• Manage internal or external staff as needed.

Required qualifications

• Bachelor's degree in scientific discipline
• 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
• 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

Nice to have

• advanced degree in Chemistry
• Prior small molecule experience

About the company

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. The company has a cutting-edge discovery and translational research platform and a pipeline of late-stage candidates.