EU Platform Regulatory Coordinator

Responsibilities

• ▹Coordinate all centralized EU regulatory operational non-core LCM activities across the Sanofi portfolio
• ▹Serve as the primary contact for GBU Regulatory Strategists, EU regulatory affiliates, CMC and labelling strategists
• ▹Manage and coordinate labelling variations, initial variations and responses to requests for supplementary information
• ▹Oversee established centralized EU activities (e.g. Article 23 procedures)
• ▹Maintain regulatory repositories and keep training materials and Ways of Working current with evolving EU regulations
• ▹Drive continuous improvement of end-to-end processes, championing automation and digitalization
• ▹Act as digital partner supporting activities aligned with the EMA Digital Roadmap (PLM/eAF/ePI, ESMP, IRIS portals)
• ▹Develop processes and reports to centralize and automate EU regulatory activities

Requirements

• ▹Minimum 3-4 years in the pharmaceutical industry
• ▹Demonstrated experience in European Regulatory Affairs
• ▹Good understanding of post-authorization regulatory activities, GxP principles and quality management systems
• ▹Proficiency with regulatory databases and document management systems, ability to generate reports and track submission metrics
• ▹Analytical, problem-solving mindset with a forward-thinking approach to digital transformation
• ▹Strong coordination, planning, project and people management skills
• ▹Ability to work effectively with multifunctional, multicultural teams
• ▹Ability to multi-task and perform well under pressure
• ▹Understanding of organizational and intercultural sensitivities
• ▹Communication and negotiation skills

Soft skills

What we offer

• ▹Supportive, future-focused team in an international work environment
• ▹"Office of the Year 2025" award-winning workplace with flexible home office policy
• ▹Thoughtful, competitive rewards package
• ▹Wide range of health and wellbeing benefits, at least 14 weeks' gender-neutral parental leave
• ▹Individual, structured onboarding with a dedicated buddy
• ▹Community events (board game nights, summer events, wellbeing lectures, sport clubs)

About the company

Sanofi is a global healthcare company driven by one purpose: chasing the miracles of science to improve people's lives.