GLOBAL REGULATORY AFFAIRS SUPPORT 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.
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 since the VIE Program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.
Only applications that are submitted in English will be considered.
JOB DESCRIPTION:
Key responsibilities will include:
- Support to the Global Regulatory Affairs, Business Unit Franchise (GBU)
- Support for the development of product/project-related global regulatory strategy
- Support for the oversight and prioritization of product/project-related activities
- Assist the Global Regulatory Team-Leader (GRT-L) for preparing for meetings, writing, meeting minutes, Sharepoint organization/maintenance, dashboards, action follow-up
- Consolidating various global information relevant for products or portfolio
- Preparation of Briefing Packages or other submission components, as necessary
- Provide support for the preparation and maintenance of the document inventory for core dossier preparation (= Product Reference File)
- Provide support for various governance committees and related documents
- Monitoring of global submissions/approval status, global oversight of Health Authority commitments, and contribute to Key Performance Indicators (KPI) monitoring
- Preparation of regulatory information for Periodic Benefit-Risk Evaluation Reports (PBRERS) and Development Safety Update Reports (DSURs)
- Coordination and submission of WHO
- related submissions, including Quality Control (QC) checks, tracking and archiving activities Provide support to GRT-L for Investigational New Drug (IND) /Clinical Trial Application (CTA) submissions (document inventory; core dossier preparation)
- Provide support to GRT-L for meeting preparation with external consultants/experts for product-related matters or Health Authority interactions
PROFILE:
Job requirements:
- Master of Science Degree in one of the life sciences or related field
- Prior Regulatory Affairs experience
- Ability to manage multiple priorities efficiently
- Proficiency in use of Microsoft Office including Outlook, Excel, PowerPoint and Word
- Strong written, verbal and interpersonal communication skills
- Full proficiency in English is a must