Regulatory Affairs Director

Job description

The Director of Regulatory Affairs is responsible for assigned regulatory strategy and operations related to unlicensed medicines (ULMs) , early access programs , and commercial product launches across Europe. This role ensures regulatory compliance while enabling timely patient access to critical therapies. The Director will help define regulatory frameworks, engage with health authorities, manage end‑to‑end launch readiness, and collaborate cross‑functionally to support business growth and operational excellence. - They will work in partnership with the Head of Regulatory Affairs, Business Unit Directors and the project teams to ensure that they are able to deliver best-in-class service and business support across the Division. - The Director Regulatory Affairs will be responsible to provide strategic guidance for regulatory activities supporting expanded access programs conducted on behalf of biotech and pharmaceutical companies. - In addition, this role will provide strategic advice and leadership for all regulatory activities supporting the approval and lifecycle management of biotechnology clients’ assets ensuring successful regulatory submissions and compliance across global...