Company Profile

Job Summary The Senior Director, Regulatory Affairs serves as the Global Regulatory Affairs Lead (GRL), responsible for developing and executing comprehensive global regulatory strategies that support the advancement and commercialization of therapeutic programs. This role oversees regulatory submissions, approvals, and compliance across multiple jurisdictions and product life cycles. The position requires strong leadership, strategic insight, and the ability to collaborate effectively with ...

Job Summary The Director of Regulatory Affairs is responsible for developing and executing global regulatory strategies, overseeing life cycle management, and ensuring compliance with all applicable regulatory requirements. This role involves managing submissions and approvals for various applications, including INDs, BLAs, CTAs, MAAs, Amendments, PIPs, and Designations, while maintaining post-approval commitments. The Director will collaborate with cross-functional teams, internal leadership, ...

Job Summary The Executive Director, Government Affairs Policy is responsible for developing and executing a comprehensive government relations and policy strategy to advance the organizations mission of delivering innovative therapies to patients with rare diseases. This leader will serve as a primary liaison with policymakers, trade associations, and other key stakeholders at the federal and state levels, ensuring the organizations perspectives are effectively represented in legislative ...