A leading healthcare provider is looking for a Regulatory/Quality 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 Regulatory/Quality 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
- Contribute to the implementation of the company's quality system and continuous improvement process
- Contribute to the monitoring, processing, and review of deviations and CAPA for operating activities
- Control and validation of promotional elements in compliance with the Marketing Authorization and the legislation on advertising
Key requirements of the Regulatory/Quality Specialist include:
- State diploma in pharmacy
- Master in Regulatory Affairs or Quality Assurance
- Experience in regulation and certification of Marketing and Promotional Information
- Knowledge of benchmarks used in the health sector: BPF, BPD, CSP and Information Charter through door-to-door sales aimed at promoting medicines
- 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
