Director, Regulatory Strategy

Role: Lead global regulatory activities for one or more development programs in biopharma, ensuring compliance and strategic alignment for compounds from preclinical stages through initial marketing applications. Responsibilities: develop and execute regulatory strategies, prepare IND/CTA/NDA/MAA submissions, author essential documentation, coordinate agency interactions, and guide cross-functional teams on regulatory requirements. Serve as primary regulatory contact with authorities and represent the company in key meetings. Requirements: BS/BA with 12+ years (or advanced degrees with relevant experience), extensive expertise in drug regulatory submissions, FDA/EMA/ICH knowledge, prior US marketing application experience preferred, and managerial skills. High-Value: significant experience in regulatory leadership within biopharma, with a focus on neurological, psychiatric, endocrine, or immunological therapies; experience across global markets; familiarity with lifecycle management and strategic agency interactions.