Executive Director, Head of Regulatory Affairs

JOB SUMMARY The Executive Director, Head of Regulatory Affairs will be responsible for overseeing all regulatory affairs activities related to the development of innovative small molecules for the treatment of cancer. This role will involve directing regulatory submissions, ensuring compliance with global regulatory requirements, and actively engaging with regulatory authorities. The ideal candidate will have a strong background in oncology and substantial experience in regulatory processes within the biotech or pharmaceutical industry. RESPONSIBILITIES Lead all aspects of regulatory affairs, including growing a high-performing regulatory team to support the development and approval of multiple pipeline assets. Develop and implement regulatory strategies for drug development that align with business objectives and timelines. Oversee the preparation and submission of regulatory documents including INDs, CTAs, BLAs, and NDAs to the FDA and other regulatory authorities. Serve as the primary point of contact for regulatory agencies and facilitate communication between the company and regulatory bodies. Provide expert regulatory guidance to cross-functional teams, including clinical development, CMC, and quality assurance. Monitor and interpret FDA regulations, guidelines, and industry standards; ensure company practices are compliant with these requirements. Communicate to leadership timely updates on changes to regulatory requirements, or other issues that may impact product development. Stay informed of the evolving landscape of oncology regulations and lead initiatives to adapt company strategy accordingly. QUALIFICATIONS Bachelor's degree in a relevant scientific discipline; advanced degree (PhD, MD, or equivalent) preferred. Minimum of 10 years of experience in regulatory affairs, with specific experience in oncology drug development. Proven track record of leading successful regulatory submissions and interactions with regulatory agencies. Deep understanding of FDA regulations, and international regulatory requirements (EMA, ICH, etc.). Strong leadership skills with experience managing cross-functional teams. Excellent communication, negotiation, and interpersonal skills. Ability to work in a fast-paced and dynamic environment, demonstrating flexibility and adaptability. #J-18808-Ljbffr

Created: 2025-03-12