Vice President/Executive Director, Regulatory Affairs About the Company Forward-thinking biopharmaceutical company Industry Biotechnology Type Privately Held About the Role The Company is seeking a Vice President/Executive Director of Regulatory Affairs to join their team. The successful candidate will be responsible for leading the development and execution of both non-clinical and clinical regulatory strategies. This includes the critical tasks of authoring and overseeing key regulatory submissions and leading interactions with the FDA and global health authorities. The role also involves serving as the global regulatory lead for assigned programs, providing cross-functional regulatory guidance, and ensuring alignment of internal stakeholders on strategic and operational regulatory goals. Applicants for the Vice President/Executive Director of Regulatory Affairs position at the company should have a strong background in regulatory affairs, with a focus on the biopharmaceutical industry. The role requires a leader who can build and maintain a high-performing regulatory function, mentor staff, and enhance regulatory processes. Ensuring compliance and engaging external consultants to support program success are also key aspects of the job. The ideal candidate will have a proven track record in regulatory affairs, including experience with INDs and BLAs, and a deep understanding of the regulatory landscape for the development of innovative, transformational medicines. A strategic mindset, excellent communication skills, and the ability to work effectively in a cross-functional environment are essential. Travel Percent Less than 10% Functions CEO/President Non-Profit Management Operations General Management Strategy Confidential
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