SANOFI’s ambition is to be an integrated World Leader in Healthcare, focused on patient needs.
Join SANOFI and take part in our ambition: to protect health, bring hope and improve the quality of life of the seven billion people in the world.
Thanks to a dynamic and diverse environment, we offer you opportunities to develop your skills, achieve your goals and contribute to breakthrough innovations in health.
In this context, Sanofi Pasteur research :
AND ALTERNATE – GLOBAL VACCINES REGULATORY AFFAIRS MANAGER (H/F)
Site de Marcy-l’Etoile (69)
Description of the assignment:
Within the Global Regulatory Affairs department of Sanofi’s Vaccines unit and in conjunction with your tutor, you will participate in the missions of the Franchise Global Regulatory Affairs Influenza Vaccines / RSV.
In this context, your missions will consist of:
- Work in close collaboration with the Global Regulatory Team Leaders (GRTLs) of the Franchise for the coordination of regulatory activities within their product regulatory teams and the RD project teams or product teams of the vaccines for which they are responsible,
- Contribute to the GRTLs for the definition and execution of the overall regulatory strategy for Franchise vaccines in connection with other functions such as the R&D, Clinical, CMC, Toxicology functions, and the Medical, Pharmacovigilance, Marketing, Industrial Affairs functions , Supply Chain, depending on the product life cycle or development plans,
- Participate in the preparation of consultations for the authorities according to the regions, in particular WHO, EMA, CDE, PMDA,
- Coordinate the preparation of clinical trial application files in collaboration with the regulatory team coordinating submissions,
- Monitor and update overall regulatory plans for planned Marketing Authorization submissions,
- Provide support to the GRTLs for the preparation and follow-up of the meetings of the product regulatory teams including the various regulatory players such as CMC, Labeling, Regional contacts, Regulatory Operations and for updating the document summarizing the Global Regulatory strategy.
Required profile :
You are looking for a work-study contract for a period of 12 monthstarting in september 2023 as part of a level training Bac +5 in Regulatory Affairs de type Faculty of Pharmacy or University.
For this position, you justify a first experience or knowledge in the field of International Regulatory Affairs or Pharmaceutical Sciences.
You master Office package software.
Working in an international environment, you are able to write and converse easily in English with non-French speakers.
Autonomous and motivated, you have good interpersonal skills and you demonstrate team spirit and adaptability.
You wish in parallel with your theoretical learning, to put them into practice immediately in business, please send us your CV and cover letter.
At Sanofi, diversity and inclusion are at the heart of how we operate and are embedded in our Core Values. We recognize that to truly harness the richness that diversity brings to us, we must be inclusive and create a work environment where those differences can flourish and be developed to improve the lives of our colleagues, patients and customers. We respect and value the diversity of our employees, their backgrounds and their experiences with the aim of equal opportunity for all. As part of its diversity commitment, Sanofi welcomes and integrates employees with disabilities.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.
