Vice President, CMC Regulatory Affairs Remote (anywhere in United States)

The Company is seeking a Vice President of CMC Regulatory to lead and oversee all aspects of CMC regulatory activities. The successful candidate will be responsible for developing and owning the global CMC regulatory strategy for the portfolio, with a focus on Phase 3 readiness, marketing application planning, and launch. This role involves serving as the primary CMC regulatory contact with global health authorities, ensuring the quality and timeliness of CMC regulatory submissions, and anticipating and addressing evolving regulatory expectations. The Vice President will also be tasked with building and leading a high-performing CMC regulatory team, setting standards for submission quality, and establishing strategic relationships with CDMO partners and internal executives. Applicants for the Vice President of CMC Regulatory position at the company should have a minimum of 15 years of experience in the biopharmaceutical industry, with at least 10 years in relevant regulatory CMC. A proven track record of successful submissions to FDA and/or other health authorities is essential. The role requires the ability to apply scientific principles to regulatory issues, motivate and lead teams, and effectively communicate and influence. The ideal candidate will be comfortable in a fast-paced, small company environment and be adept at adjusting to changing priorities. A BS degree in a related field is required, with an advanced degree preferred.

Hiring Company

Kailera Therapeutics