Regulatory Affairs Director, France

Job description

Job Description General Summary: As Regulatory Affairs Director and member of the Country Leadership Team, management of company Marketing Authorizations (MA) at the country level. As Responsible Person, contributes to the general management of Vertex Pharmaceuticals (France) as a Exploitant pharmaceutical establishment and responsible for all pharmaceutical operations (e.g. GMP, Public Health Code, supervision of promotional material). Key Duties and Responsibilities: - Member of the Vertex France Leadership Team advising on regulatory requirements for the Vertex marketed and pipeline portfolio. - Act as the contact person for the health authorities and professional organizations. - Implement regulatory/legal surveillance - Ensure that each employee of Vertex Pharmaceuticals (France) SAS receives high-level initial and ongoing training in regulatory area (Exploitant / Charter on Information / GMP / GDP) enabling them to develop knowledge and skills that match their position, in conjunction with the Human Resources Director. - Contributes to ensure the operational relationship with the MA holder (functional link with the International Quality Director of Vertex Pharmaceuticals Euro...