REGULATORY AFFAIRS OFFICER 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:
Regulatory Affairs Officer
- VIE Contract (W/M)
The Regional Europe Excellence VIE will be responsible for coordinating operational excellence activities within the Global Regulatory Affairs (RA) governance and country management in collaboration with European RA countries.
Responsibilities:
Participation in regulatory activities:
- Reviewing and commenting on specific Standard Operating Procedures
- Consolidation of RA teams mapping and activities
- Monitoring of regulatory activities through analyzing and reporting of performance indicators
Participation in transversal projects, such as:
- Post-approval commitments (PAC) oversight
- Health Authority Safety Requests (HASR) oversight
- Safety requests and RMP (risk minimization plan)
- Article 23 preparation
- SHARE Quality Control monitoring
- Discontinuation process and portfolio rationalization
- Participation to Audits and inspection preparation
- Extended EudraVifilance Medical Product Dictionary (xEVMPD) / Identification of medicinal products (IDMP)
- Labelling submission monitoring
- Portfolio integration
Participation and preparation of specific meetings for:
- Experiences sharing across the RA country teams
- Projects and products review
- Monthly Teleconferences with EU country RA Heads
- Annual EU RA Seminar
- New comer training
Requirements:
- Master Degree in Life Sciences / Pharmacy (or last year of Pharmacy study, physician, Ph.
D. or master of Sciences)
- First experience in Regulatory Affairs/ Medical/ Pharmacovigilance and/or drug development is required
- Project management skills
- Adaptive/flexible person
- Good communication skills / Negotiation skills
- Good level of oral and written communication
- Good level of analytical skills
- Good level of computer skills
- Ability to solve issues / Pro-active behaviour
- Ability to work as an individual and with multi-function teams
- Ability to manage multi projects in short timelines
- Fluent English
- French would be a big plus