REGULATORY AFFAIRS OFFICER

Job description

Enterprise:
Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. More than 110,000 people at Sanofi are dedicated to make a difference on patients’ daily life, wherever they live and enable them to enjoy a healthier life.
Program SaVIE (VIE of Sanofi) is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.
PLEASE NOTE that since the VIE Program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.
PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered.
We are looking for a candidate for a VIE mission of:
Regulatory Affairs Officer
- VIE Contract
Job Specification:
The Regional Europe Governance and Countries Management team member will be responsible for coordinating operational excellence and strategic governance with the EU Regulatory country teams.
Key respoonsibilities include:
- Coordination of transverse projects: in particular tracking/oversight on post-approval commitment
- Safety requests and RMP (risk minimization plan), article 23 and discontinuation process
- Participate to communication channels to strengthen experiences sharing across the Regulatory Affairs country teams
- Projects and products review
- Monthly Teleconferences s with EU country RA Heads
- Annual EU RA Seminar
- New comer training
Candidate Profile and requirements:
Education :
Pharmacist / Scientist (Education
- "Bac +5/6 years" Sciences / Pharmacy),
Degree in Regulatory (eg "DESS droit de la santé ", Master)
Experience :
First experience in Regulatory Affairs is required
Professional skills and attitude :
- Project management skills
- Adaptive/flexible person
- Good communication skills / Negotiation skills
- Good level of oral and written communication
- Ability to solve issue / Pro-active behavior
- Ability to work with multi-function teams
- Ability to manage multi projects in short timelines
Languages:
Full proficiency in English is a must