Executive Director, Regulatory Strategy, Cell & Gene Therapy

General Summary: The Executive Director, Regulatory Strategy will oversee development and implementation of global regulatory strategies for product development and commercialization within the T1D portfolio. Manages global/regional regulatory professionals and shapes cohesive regulatory strategy across programs. Key Duties And Responsibilities: Lead regulatory strategy development for multiple T1D projects from FIH through post-marketing application stages. Ensure global regulatory strategy aligns with corporate business objectives and is negotiated with relevant health authorities as appropriate. Coordinate unified regulatory input with global program leads and regional representatives across development, clinical, and commercial teams. Review, author, and ensure quality of regulatory submission documents and Health Authority communications. Counsel senior management on Regulatory Affairs strategy/tactics, procedures, and practices. Create/assess project plans and timelines; assign/manage staff; prioritize work and meet key goals; support staff career growth. Influence the regulatory environment via conferences, industry/agency regulatory meetings, committees, and trade associations. Sponsor continuous improvement of department processes/strategies; provide resource planning recommendations. Knowledge And Skills: Expertise in regulatory affairs science and global/regional/local regulatory frameworks for pharmaceutical development. Advanced knowledge of R&D, preclinical/clinical requirements, drug registration, and maintenance. Strong skills in analyzing/interpreting data, protocols, safety reporting, and labeling. Advanced ability to create and assess regulatory path/clinical plan proposals and lead health authority interactions. Ability to navigate ambiguity; strategic thinking; excellent written/verbal communication; strong matrix leadership. Education And Experience: Bachelor’s degree in Biology, Chemistry, or related field. Typically 15 years of relevant pharmaceutical/biotech regulatory affairs experience and 7 years supervisory/management experience (or equivalent). #J-18808-Ljbffr Scorpion Therapeutics