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Regulatory Affairs Product Manager

Posted 23 Mar 2024
Work experience
5 to 7 years
Full-time / part-time
Full-time
Job function
Degree level
Required language
English (Fluent)

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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

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.

Pharmaceutical
Amsterdam
100,000 employees