A leading healthcare provider is looking for an RA specialist to join their newly expanded pharmaceuticals division based in Paris. This role would join a dynamic team working with some of the top products in the field of diagnostics.
Key responsibilities of the RA Specialist include:
- Responsibility and support for the life cycle management of pharmaceuticals such as:
- marketing authorization applications
- variations
- renewals
- responses to questions from authorities
- Management of local regulatory activities
- Prepare and submit translations of local documents (AMM Annexes) in accordance with local requirements
- Regulatory watch on national and European legislation
- Contribution to negotiations with the authorities
- Control and validation of promotional elements in compliance with the Marketing Authorization and the legislation on advertising
Key requirements of the RA Specialist include:
- State diploma in pharmacy
- Master in Regulatory Affairs
- Experience in regulation and certification of Marketing and Promotional Information
- Strong analytical skills
- Ability to work independently with minimal supervision on projects and activities
- Ability to prioritize, plan and evaluate deliverables
- Fluent English and French
- Previous MS Office experience using spreadsheets and presentation software
