Regulatory Affairs and Pharmacovigilance Manager

A full-service CRO that supports biotech, biopharma, and pharmaceutical companies globally is seeking a Regulatory Affairs and Pharmacovigilance Manager for their Rennes location in Northwest France.

This role is pivotal for managing clinical trial authorisations, setting up pharmacovigilance systems, and overseeing post-market surveillance. The position requires on-site presence.


Role:

• Prepare and submit applications for clinical trial authorisations to relevant authorities.
• Oversee the entire approval process for clinical trial dossiers.
• Handle importation of experimental drugs and manage submissions with local authorised bodies.
• Establish and implement pharmacovigilance systems from scratch, including SOPs and planning.
• Conduct post-market surveillance and monitor serious adverse events within pharmacovigilance databases and on the European Eudravigilance platform.
• Collaborate with clinical operations teams, sponsors, and relevant authorities.
• Assist in drafting and reviewing pharmacy procedures for studies in Europe and the USA.

Qualifications:

• Required: Diploma or extensive experience in Pharmacy.
• Preferred: Higher education in regulatory affairs.
• Ideally, at least 1 year of experience in a CRO or pharmaceutical industry.
• Professional proficiency in English.
• Demonstrated ability to manage multiple projects with high quality.

Apply now to join a team dedicated to advancing global pharmaceutical development. For questions or to hear about similar positions in the regulatory affairs field, please reach out directly.