DOSSIER SUBMISSION MANAGER HF

Job description

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:
Dossier Submission Manager
- VIE Contract (W/M)
Key accountabilities :
- Responsible for activities related to planning and coordination of dossiers production and submission to Health Authorities (new drug registration dossiers, safety and non-safety labelling changes, Chemistry, Manufacturing and control [CMC] changes)
- Take part in ad-hoc committees as Global Regulatory Operations Expert (submission task force, global project team, pre-submission meetings, etc.) to bring Regulatory Operations expertise for dossiers during submission preparation
- Primary point of contact and source of information in dossier submission management within GRA (Global Regulatory Affairs)
- Contribute to regulatory updates interpretation/implementation, procedures maintenance and new process implementation
- Responsible for dossier submission in Europe
- Interact as expert in multidisciplinary working groups and with local affiliates concerning dossier submission to Health Authorities
- Ensure high quality of dossiers submitted to Health Authorities
Candidate's profile:
- Education: relevant scientific Master degree or Pharm.
D.
- Experience: at least 1 year of relevant professional experience
- Soft skills: attention to detail, team player
- IT tools: MS Office
- Languages: fluent English, at least intermediate French