Vice President, US Regulatory Affairs

The Company is seeking a Vice President of US Regulatory Affairs to lead regulatory strategy and activities for its rare disease portfolio across development and marketed products. Responsibilities include directing regulatory interactions and submissions, overseeing FDA engagement, and ensuring compliance with regulatory, promotional, post-market safety, and pharmacovigilance requirements. The role will guide regulatory planning throughout product development and lifecycle management, contribute to global strategy, and provide regulatory intelligence to inform business decisions. The Vice President will build and lead a high-performing regulatory team, collaborate with global and cross-functional partners, and advise on regulatory risks and opportunities in business development. Candidates should have at least 15 years of progressive experience leading regulatory strategy, preparing major submissions, and negotiating product labels, along with direct experience in FDA interactions and filings. An advanced scientific degree is preferred. Required expertise includes rare diseases, small and large molecules, FDA requirements for investigational products and IND, NDA, and BLA submissions, and product lifecycle management. Candidates should also understand global regulatory frameworks and CTD/eCTD formats, and bring strong scientific writing, strategic thinking, and experience leading cross-functional teams in international, matrixed organizations.