A leading healthcare/diagnostics provider in Paris is looking for an experienced Regulatory Affairs candidate to join their growing team. This company is a world leader in its area, with a presence across 160+ countries worldwide and 50,000+ employees.
Responsibilities of the RA Manager include:
- Support for the lifecycle management of pharmaceuticals such as marketing authorization applications, variations, renewals and responses to questions from authorities
- Prepare and submit translations of local documents (AMM Annexes) in accordance with local requirements
- Create and update regulatory texts (SPC, Instructions and labeling)
- Regulatory watch on national and European legislation to ensure regulatory compliance of Pharmaceutical Diagnostics products in France
- Preparation and implementation of requests for price / reimbursement or Authorization to Communities at HAS and CEPS
- Control and validation of promotional elements in compliance with the Marketing Authorization and the legislation on advertising
- Implementation of strategies to improve existing processes (revision of local procedures, etc.) and implementation of new initiatives to support sales teams
Requirements for the role:
- MSc in Regulatory affairs, Pharmacist background preferred
- 4+ years' experience working in RA in France
- Hands-on experience with marketing/promotional material for pharmaceuticals
- Ability to work independently between departments
- Ability to establish relationships within French Regulatory Affairs, Group Regulatory Affairs and with other functions within the French organization
- Excellent organisational and communication skills
- Fluent French and English (at least C1 level)
Benefits include:
- Permanent employment at a world leader in its field
- Competitive salary package including variable bonus