Hybrid (work remotely up to two days per week; or on-site five days per week with ad hoc flexibility)
French and european legislation
Marketing authorizations management
Responsible person duties
Vertex Pharmaceuticals is seeking a Regulatory Affairs Director in France to oversee marketing authorizations and ensure compliance with pharmaceutical operations. The ideal candidate should be a qualified pharmacist with extensive experience in regulatory affairs and a strong understanding of French and European legislation
Job Summary
As Regulatory Affairs Director and member of the Country Leadership Team, you will manage company Marketing Authorizations at the country level and contribute to the general management of Vertex Pharmaceuticals (France) as a pharmaceutical establishment.
Key duties include acting as the contact person for health authorities, implementing regulatory surveillance, and ensuring employee training in regulatory areas.
You will be responsible for the creation of the application for the opening of the Exploitant pharmaceutical establishment, organizing and supervising various pharmaceutical operations, and ensuring regulatory compliance.
Matching Summary
Match Score: 85
Vertex Pharmaceuticals is seeking a Regulatory Affairs Director in France to oversee marketing authorizations and ensure compliance with pharmaceutical operations. The ideal candidate should be a qualified pharmacist with extensive experience in regulatory affairs and a strong understanding of French and European legislation.
Skills & Requirements
Must-have
French and European Legislation
Marketing Authorizations management
Responsible Person duties
pharmaceutical operations
regulatory compliance
advertising control
Nice-to-have
scientific information validation
quality audits of suppliers
research and study programs
Key Requirements
Pharmacist qualified for registration in section B
Training in Pharmacovigilance
PhD with healthcare law degree preferred
At least 10 years' experience as Responsible Pharmacist or Deputy