Vice President, Regulatory Affairs

The Company is seeking a Vice President of Regulatory Affairs to lead global regulatory strategy for an assigned disease area, guiding programs from early development through approval, launch, and lifecycle management. The role includes developing regulatory plans with cross-functional teams and leading the preparation, review, and submission of regulatory documents. The Vice President will represent Regulatory Affairs on program teams and in business development activities, and serve as a primary liaison with US and international health authorities. Additional responsibilities include supporting compliance initiatives, audits, and inspections; overseeing external regulatory partners; and improving departmental systems and processes. Candidates must hold an undergraduate degree; an advanced degree is preferred. At least 10 years of relevant pharmaceutical or biotechnology regulatory affairs experience is required, including deep expertise in global strategy from early development through approval and post-approval. Applicants should have strong knowledge of US and European regulatory requirements, FDA and ICH guidelines, and experience leading formal health authority interactions; experience with approval submissions and expedited development programs is an advantage. The role also requires excellent communication, writing, organizational, and prioritization skills, along with experience mentoring and developing staff. Candidates should be collaborative, adaptable, and able to translate regulatory requirements into practical plans while delivering results in a fast-paced environment.