Regulatory Affairs Specialist
il y a 2 semaines
Reporting to the Regulatory Affairs Directorate, your key responsibilities will include:
1 – Regulatory Affairs Activities
- Organizing and managing Regulatory Affairs activities for products under your responsibility, ensuring compliance with applicable regulations.
- Maintaining the validity of existing Market Authorizations (MAs) in line with the company strategy.
- Serving as the primary contact for healthcare authorities during regulatory procedures.
2 – Product Registration and Maintenance
- Preparing and submitting registration dossiers, ensuring coherence between constituent parts.
- Monitoring regulatory dossier projects and assessing feedback from healthcare authorities.
- Managing scientific support for export registrations and implementing necessary actions for MA obtention.
3 – Regulatory Monitoring and Control
- Validating packaging items and ensuring compliance with MA and applicable procedures.
- Regulatory monitoring of promotional elements and ANSM follow-up.
- Monitoring regulatory activities on internal databases and participating in department meetings.
Profile:
Pharmacist with at least 5 years of experience in Regulatory Affairs, fluent in English, available for immediate full-time employment with the possibility of working from home 2 days a week.
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