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Poste
Mission
The regulatory affairs specialist would be responsible for implementing the regulatory strategy for products in development, for activities related to the authorization and maintenance of clinical trials, in compliance with the regulations in force and the deadlines set.
Will also be required to participate in the implementation and maintenance of the quality system inherent to Regulatory activities.
Main Activities
- Participate in the planning of regulatory activities for the clinical trial(s) in progress;
- Follow up on regulatory maintenance in conjunction with the service provider for the clinical trial(s) in progress;
- Participate in the drafting and coordinate the review of regulatory documents in accordance with applicable regulations (Investigator Brochure, Development Safety Update Report (DSUR) and potentially: initial clinical trial submission, briefing documents for interactions with EU/US agencies, Pediatric Investigation Plan, Orphan Drug Designation);
- Provide regulatory support to other departments;
- Conduct impact analysis of clinical trial regulatory monitoring;
- Drafting or updating of procedures / documents related to Regulatory Affairs.
Profil
- Bac +5 in Regulatory Affairs, Quality, Drug and Health Products Sciences, Pharmacy;
- First experience within a regulatory affairs department;
- Scientific and regulatory knowledge related to pharmaceutical affairs and clinical trials;
- Knowledge of quality standards;
- Able to manage a project in collaboration with a cross-functional team;
- Excellent written and oral expression in French and English.
- Writing skills, knowing how to write submission files containing the right level of information, knowing how to synthesize scientific data;
Postuler