As Regulatory Affairs Director and member of the Country Leadership Team, you will manage company Marketing Authorizations at the country level
Job Summary
As Regulatory Affairs Director and member of the Country Leadership Team, you will manage company Marketing Authorizations at the country level.
You will act as the contact person for health authorities and professional organizations, and implement regulatory/legal surveillance.
This role is responsible for ensuring compliance with all Vertex Pharmaceuticals (France) SAS and Vertex global SOPs, policies, and quality system requirements.
Matching Summary
As Regulatory Affairs Director and member of the Country Leadership Team, you will manage company Marketing Authorizations at the country level.
Skills & Requirements
Must-have
Management of company Marketing Authorizations
Contact person for health authorities
Implementation of regulatory/legal surveillance
Control of advertising in accordance with Public Health Code
Management of technical product complaints
Monitoring of batches and product withdrawal
Nice-to-have
Contribution to general management of pharmaceutical establishment
Supervision of promotional material
Ensuring regulatory compliance of pharmaceutical suppliers
Key Requirements
Pharmacist, qualified for registration in section B
Training in Pharmacovigilance
At least 10 years’ experience as Responsible Pharmacist or Deputy