Chargé d’Affaires Réglementaires F/H
Core
Prepare, submit, and track regulatory dossiers for clinical studies involving medicines and medical devices in France and internationally.
Role type
Regulatory Affairs Specialist (Clinical Research)
Builds
Regulatory submissions for clinical trials
Domain
Healthcare / Clinical Research / Regulatory Affairs
Required skills
Regulatory dossier preparation, submission tracking, stakeholder coordination, regulatory compliance monitoring, regulatory intelligence, clinical trial regulations knowledge (EU 536/2014, MDR/IVDR), scientific degree (Bac+5), English fluency
Preferred skills
Pharmacist qualification, CRO or pharmaceutical lab experience
Technologies
EU 536/2014, MDR, IVDR
Responsibilities
Prepare and submit regulatory dossiers for clinical study initiation and follow-up; track submission progress and ensure deadline adherence; coordinate with regulatory authorities, ethics committees, and clinical research teams; ensure regulatory compliance for studies; monitor regulatory updates at European and international levels
Seniority
Mid-level, hands-on IC