About the job
Join Sanofi Global Regulatory Affairs team as Regulatory Project Manager – Immuno & Inflammation (I&I). In this role you will be responsible for managing regulatory activities and EU strategy for a marketed product with an active Life Cycle Management.
Possible working locations: Europe
- Develop regulatory strategy for Europe and provide regulatory expertise for the project/indication assigned
- Define, coordinate and contribute to the preparation of CTA, IMPD, DSUR and major regulatory submission (i.e. MAA and non-EU Region EU countries) and/or any type of responses document to region Health Authority questions with the stakeholders (nonclinical, clinical, Medical, Pharmacovigilance, etc.)
- Ensure maintenance and compliance of regulatory activities for both development and life-cycle activities, including Veeva responsibilities
- Participate to the Regulatory sub-teams within GRA and be the regional regulatory representative in outside Regional GRA multi-function teams
- Lead and coordinate scientific advices (including briefing package preparation), oral explanations and pre-submission meetings
- Provide operational support to the other Product Regulatory Managers in any major regulatory submissions (e.g., Scientific advice request or type II variations) that would have to be prioritized during the period
- Contribute to the execution of the Region Europe agency relations management strategy
- Follow regulatory intelligence updates and competitor’s status and assess potential impact on daily activities and project strategy, including sharing with the appropriate stakeholders within the department or project team(s)
- Master’s degree in a Life Sciences subject, e.g. Physician, Pharmacist, Veterinarian or other Life Sciences Degree
- 2+ years of experience in EU Regulatory Affairs
- Good knowledge and operational expertise of EU regulations, and ability to implement this into regulatory strategy and practice
- Development and business environment understanding
- Ability to produce written and oral regulatory or scientific communications with clarity and accuracy; ability to communicate effectively and efficiently with other functions in the business, as well as with the Health Authorities
- Solution finder, proactivity, organization and communication skills
- Oral and written fluency in English
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