Responsable Affaires Réglementaires et Pharmacovigilance (RPV/LSO) - Pharmacien Responsable Intérimaire
CSL • Baltimore, Maryland, United States
Posted April 10, 2026
Full Time
About the Company
CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our businesses, CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. See our community guidelines: https://bit.ly/3Bs17Ra
Job Description
Seeking a Regulatory Affairs and Pharmacovigilance Manager to ensure regulatory compliance and quality of laboratory activities in Seqirus France.
Requirements
- Reviewing and controlling promotional and non-promotional documents
- Preparing and chairing cross-functional meetings
- Ensuring timely submission of marketing authorization applications to regulatory authorities
- Validating product information before signature
- Coordinating with sales, marketing, medical, and economic departments
- Managing product listings
- Preparing and filing market authorization applications
- Coordinating with international regulatory affairs departments
- Managing the pharmacovigilance system
- Monitoring adverse event reports
- Ensuring compliance with regulatory requirements
