Executive Director, Regulatory Affairs

Executive Director, Regulatory Affairs About the Company Innovative biopharmaceutical company IndustryPharmaceuticals TypePublic Company Founded2018 Employees51-200 Funding$200+ million Categories PharmaceuticalsBiotechnologyHealth CareMedicineManufacturingChemical Products About the Role The Company is seeking an Executive Director for Regulatory Affairs to provide global regulatory leadership in the development, registration, and life-cycle management of innovative oncology programs. The successful candidate will be responsible for overseeing the preparation of all regulatory documents and submissions, mentoring junior team members, and ensuring compliance with FDA, EU, and other global regulations. This role requires a proven leader with a strong managerial background, a deep understanding of oncology development and commercialization, and the ability to proactively identify and address regulatory issues. The Executive Director will also be the direct point of contact with health authorities, driving the planning and implementation of regulatory meetings, and representing the company in all regulatory interactions. Applicants for the Executive Director, Regulatory Affairs position at the company should have a minimum of a Bachelor's degree in a relevant scientific field, with at least 15 years of experience, and a preference for an advanced scientific degree. A background in oncology is strongly preferred, as is experience in a global regulatory environment. The role demands a candidate with a strong knowledge of FDA and EU regulations, eCTD elements, and regulatory writing skills. The ideal candidate will be a problem-solver, personable, credible, and possess strong communication, accountability, and adaptability skills. They should be adept at managing in an ambiguous environment, embracing change, and demonstrating emotional intelligence and curiosity in their approach to building and improving regulatory strategies. Hiring Manager TitleChief Regulatory Officer Travel PercentLess than 10% Functions CEO/PresidentNon-Profit ManagementOperationsGeneral ManagementStrategy

Created: 2025-01-30