DOSSIER SUBMISSION COORDINATOR HF

Job description

Please note that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi Pasteur worldwide.
Therefore, it is STRONGLY RECOMMENDED that you post your resume in English.
The VIE Program is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.
COMPANY:
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. We distribute more than 1 billion doses of vaccine per year, making it possible to vaccinate more than 500 million people across the world and save more than 3 million lives
JOB DESCRIPTION:
- Responsible for activities related to planning and coordination of dossiers production and submission.
- Take part to 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.
- Expert in dossier submission in Europe and worldwide.
- Primary contact point and information source in dossier submission management within Global Regulatory Affairs.
- Contribute to regulatory updates interpretation/implementation, procedures maintenance and new process implementation.
- Implication as Expert in multidisciplinary working groups.
- Interact as Expert with local affiliates concerning dossier submission
- Ensure high quality of dossiers submitted to Health Authorities.
CANDIDATE'S PROFILE:
Education:
Master's degree
Experience:
- At least two/three years of experience in Regulatory Affairs preferentially at Corporate level.
- Experience in dossiers and/or documents to be submitted to Health Authorities.
- Experience in dossier submissions.
- Experience in project and dossier planification.
- Knowledge in dossier publishing and reviewing tools.
Skills and knowledge required:
- Knowledge in technical and regulatory requirements related to submissions dossiers.
- Expertise in European dossier types (structures, procedures).
- Knowledge in different types of US and international dossier.
- Knowledge in electronic documents management systems, databases, dossiers and publishing tools.
- Good level of expertise in planning methods and tools.
- Ability to coordinate, organize and plan in an efficient and effective manner.
- Ability to deal with conflicting priorities in constantly changing environment.
- Negotiation and communication skills with internal and external stakeholders.
- Ability to work in multidisciplinary and multicultural environment.
Languages:
- Fluency in English mandatory