REGULATORY AFFAIRS CONSULTANT

Description de l'offre

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 in patients’ daily life, wherever they live and enable them to enjoy a healthier life.
iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.
PLEASE NOTE that since this 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.
At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. 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 employees, patients and customers.
We are looking for a candidate for a VIE mission of:
Regulatory Affairs Consultant
- VIE Contract (W/M)
VIE will be fully integrated into the Regulatory Affairs (RA) team of the Swiss affiliate. The person will be trained in all the Swiss regulatory activities required for the role. VIE will participate in the daily activities, meetings and strategic thinking of the RA Department and will be in charge of managing a product portfolio.
Main duties:
- Preparation and submission of regulatory variations such as Labeling, Chemistry, Manufacturing and Controls (CMC) to Swissmedic
- Follow-up of submissions
- Management of Corporate requests concerning registered files
- Preparation and submission of special requests (co-marketings, Marketing Authorization renewals, etc.)
- Participation in strategic registration discussions (within the department, with marketing, medical, logistics, etc.)
- Participation in specific projects (related to service, subsidiary or new products)
- Updating or drafting of internal procedures
- Continuous updating of the Group and local databases
- Initiation and handling of submissions in electronic Common Technical Document (publishing)
- Serving as the Regulatory representative on specific multi-discipline teams
- Cooperating with the Swiss health authorities (Swissmedic)
Candidate's profile:
- Education: Master's degree, preferably in pharmacy or other scientific degree
- Experience: previous experience in Regulatory Affairs would be an asset; pharmaceutical industry experience is preferred
- Soft skills: critical mind; conscientious, accurate, with a sense of organization and analysis; team spirit; great communication skills
- IT skills: at ease with MS Office suite (Word, Excel, PowerPoint)
- Languages: fluent French and English; knowledge of German would be an asset