Regulatory Affairs Director

Job description

Regulatory Affairs Director Oncology R&D: Gaithersburg, MD: Hybrid Work- on average 3 days a week from office The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialisation, and life cycle management of the assigned cell and gene therapy (CGT) product(s). You'll s erve as the global regulatory lead ( GRL ) on early - stage projects or be responsible for specific indications or jurisdictions of larger programs . You'll have the opportunity to contribute significantly to product and clinical strategy and support cross-functional alignment for governance and health authority interactions . Th e RAD also serves as the face of the company with Health Authoritie s. What you'll do: A ccountable for leading the development and implementation of the regional or global regulatory strategy for a CGT product/group of products. E nsure s that the strategy is designed for efficient development tailored to the global or specific regional regulatory environment (s), and to deliver approval s aligned to the needs of the business, markets and patients. This includes optimizing the health authority engagement strategy , aligning cr...