REGULATORY SUBMISSION MANAGEMENT LEAD

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 Submission Management Lead
- VIE Contract (W/M)
Key responsibilities:
- Provide value to the GBU (Global Business Unit) Submission Management Team and the portfolio we support by delivering on key initiatives and special projects
- Coordinate, drive the development and implementation of a GBU Submission Management Tool-Kit for Major Marketing Applications
- Provide organizational support of GBU contributions towards a M&A (Mergers & Acquisitions) playbook
- Work closely with the GBU Submission Management Head and Dossier Leads in order to manage team efforts and present deliverables that meet team needs
- Engage with our key stakeholders and partners (Global Regulatory Teams and Regional Submission Management Platforms for example) to ensure a comprehensive solution and holistic approach to effective GBU submission management of New Marketing Applications and successful integrations
- Work with the Americas Platform with a focus on US Annual Reports
- Assist in the integration of Pasteur Annual Report (CMC
- Chemistry, Manufacturing and Control
- Annual Reportable Changes) planning and publish into existing processes in Submissions Management
Candidate's profile:
- Education: Master degree in Regulatory; scientific/business background is welcome
- Experience: at least 1 year of relevant professional experience (in Regulatory); project management experience is a plus
- Soft skills: attention to detail; good communication skills; strong project management skills; team player; ability to work within given deadlines
- IT tools: MS Office (Excel skills; MS Project or Sharepoint experience is welcome)
- Languages: fluent English
Avant de postuler, veillez à vérifier les conditions d’éligibilité pour cette destination http://www.civiweb.com/FR/le-volontariat-international/conditions-du-VIE.aspx
Le visa requis dans le cadre d’une mission VIE est en effet soumis à des conditions de formation et/ou d’expérience »