Regulatory Affairs Project Coordinator
il y a 1 semaine
Join Groupe ProductLife as a Regulatory Affairs Project Coordinator and contribute to the success of our global life sciences industry clients.
About the Role:We are seeking a highly motivated and organized Regulatory Affairs Project Coordinator to join our team. As a key member of our Regulatory Affairs team, you will be responsible for coordinating activities for our clients, including post-MA regulatory activities related to International and EU markets.
Key Responsibilities:- Coordinate activities for clients, including renewals, safety and quality variations for 3 therapeutics areas in French speaking and non-French speaking areas.
- Manage CCDS (Company Core Data Sheet) and Product Information updates.
- Manage CEP (Certificate of Suitability) and ASMF (Active Substance Master File): regulatory assessment of new versions and writing of variation packages.
- Respond to internal requests for technical and/or regulatory information.
- Monitor and maintain up-to-date knowledge of international and European guidelines/legislation.
- Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data.
- At least a Bachelor's Degree in Life Sciences, ideally a Pharmacy Degree (PharmD).
- International markets LifeCycle Maintenance (LCM) experience.
- Experience in managing CCDS (Company Core Data Sheet) and Product Information updates.
- Experience in managing CEP (Certificate of Suitability) and ASMF (Active Substance Master File).
- Strong computer skills, including MS Office applications, data and document management systems.
- Fluency in French and English is mandatory.
Groupe ProductLife is a global industry leader in regulatory outsourcing and consulting services for the life sciences industry. With offices across Europe, the Middle East, Asia, Africa, Latin America, and North America, we provide world-class services to our clients. Our team is driven, talented, and motivated by a supportive environment and opportunities to learn and grow professionally.
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