Regulatory Affairs Manager (M/F)

SUPPLAY is recruiting for SANOFI a Regulatory Affairs Manager (M/F) for a 12-month mission at the Val-de-Reuil site.

Remuneration: €3,775.88 gross monthly

Your missions

Within the Regulatory Affairs team reporting to the site's Quality department, you will contribute to maintaining the regulatory compliance of vaccines marketed by SANOFI.

Main responsibilities Regulatory assessment of changes Assess the regulatory impact of changes initiated by the Val-de-Reuil site as well as supplier notifications. Interact with the Global Regulatory Affairs teams when changes present a regulatory impact. Participate in the site's Change Committees. Contribute to working groups within the framework of projects requiring a regulatory assessment. Management and monitoring of regulatory actions Ensure the monitoring of regulatory actions in the site's quality database. Guarantee their closure in compliance with internal procedures. Ensure the harmonization of regulatory impact assessments. Provide regulatory monitoring regarding the pre-assessment of changes. Management of regulatory data Validate the interface links between the regulatory tool Vault RIM and SAP. Transmit regulatory data during the creation of article codes. Implement the company tools necessary for the performance and monitoring of regulatory activities.

Profile sought Education Bac +4 / Bac +5 in Chemistry, Biochemistry or Regulatory Affairs. Pharmacist or holder of a Master's in Regulatory Affairs. Experience 2 to 5 years of experience in Regulatory Affairs. Experience acquired in the pharmaceutical or biotechnology industry. Required skills Proficiency in professional English, both written and spoken. Analytical, microbiological or pharmaceutical technology knowledge. Good knowledge of Good Manufacturing Practices (GMP). Mastery of quality processes in the pharmaceutical sector. Knowledge of regulatory dossiers, guidelines and regulatory directives. Desired qualities Ability to work in a team and cross-functionally. Sense of organization and ability to coordinate multiple subjects simultaneously. Ability to anticipate, analyze and synthesize. Proactive. Ability to argue and make decisions. Rigor and autonomy.