SANOFI’s ambition is to be an integrated World Leader in Healthcare, focused on the needs of patients.
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 REGULATORY AFFAIRS OFFICER CMC (H/F)
Site de Marcy-l’Etoile (69)
Description of the assignment:
Within Sanofi Pasteur’s Global Regulatory Affairs department and in conjunction with your tutor, you will take part in the drafting in English of the regulatory files (sections CTD -Common Technical Document- modules 2.3 and 3.2) as well as in the drafting of answers to questions from Health Authorities in accordance with European, Canadian, American and international regulatory requirements.
In this context, your missions will consist of:
- Participate in the identification of documents/information necessary for scientific demonstrations with experts and subcontractors,
- Provide support for the analysis and synthesis of scientific data from the documents collected and coordinate regulatory drafting activities,
- Take part in the organization of meetings with experts to validate editorial choices,
- Participate and/or organize meetings with subcontractors,
- Be a player in the regulatory strategy within the department,
- Provide support to the multi-project team within the framework of regulatory activities.
Required profile :
You are looking for a work-study contract for a period of 12 monthstarting in september 2022 as part of a level training Bac +6 in Regulatory Affairs de type School of Engineering, Faculty of Pharmacy or University.
For this position, you justify a first experience or knowledge in the field ofs Regulatory Affairs.
You master Office package software. Knowledge of Veeva-Vault would be a plus.
Working in an international environment, you are able to converse easily in English with non-French speakers.
Rigorous, you are recognized for your writing skills and your analytical mind. For this work-study program, you are curious and you like working in a team and interacting on cross-functional subjects. You have an appetite for computer tools.
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.
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