Your Mission
New opportunity available within the Sanofi Vaccines Global Regulatory Affairs team for a Europe Regulatory Affairs Product Manager role!
You will be accountable for managing products under development and/or marketed products.
Main responsibilities
- Develop Europe regulatory strategy and provide regulatory expertise within project/product teams for products under development and/or marketed products as required
- Define, coordinate and contribute to the preparation of major regulatory submission (e.g. MAA, indication extensions, labelling variations…), CTA, PBRER, DSUR and/or any type of responses document to Europe Health Authority (HA) questions with the stakeholders (Non-clinical, Clinical, Medical, Pharmacovigilance, etc.)
- Lead and coordinate interactions with European HA: Scientific advice (including briefing package preparation), oral explanations and pre-submission meetings
- Follow regulatory changes, competitor's status and assess potential impact on daily activities and project strategy
- Provide regional inputs, updates, and reviews of Global Regulatory Product Strategies as needed. Ensure maintenance and compliance of regulatory activities for development and marketed products
About you
- 5+ years of experience in the pharmaceutical industry
- Demonstrated experiences in regulatory affairs
- Comprehensive knowledge and operational expertise of the EU regulations,
- Ability to work with multifunctional and multicultural teams
- Ability to produce written and oral regulatory or scientific communications with clarity, accuracy and rigor
- Ability to communicate effectively and efficiently with other functional departments in the business
- Good relationship ability
- Ability to resolve issues and proactivity
- Physician, Pharmacist, Veterinarian or Life Sciences Bachelor’s Degree
- Fluent English