GLOBAL REGULATORY AFFAIRS EU COORDINATOR (M/W)

UPSA; Rueil-Malmaison; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A leading pharmaceutical company in France is seeking an experienced EU Coordinator for Regulatory Affairs. The role involves coordinating regulatory activities, ensuring compliance, and collaborating with diverse teams. Candidates should have at least 10 years of relevant experience, solid knowledge of RIM systems, and fluency in both French and English. This position offers opportunities to contribute to critical regulatory processes in a dynamic environment.

Qualifications

• 10 years experience in Regulatory Affairs with exposure to EU procedures.
• Solid knowledge of RIM systems.
• Fluency in French and English.

Responsabilités

• Lead global planning of maintenance activities related to EU procedures.
• Prepare documentation packages with relevant stakeholders.
• Monitor KPIs for EU Regulatory activities.

Connaissances

Regulatory Affairs

RIM systems knowledge

Organizational skills

Bilingual French & English

IT proficiency

Outils

Word

Excel

PowerPoint

Outlook

SharePoint

Description du poste

Founded in 1935, UPSA is today both a mid-sized company with one of the largest pharmaceutical industrial sites in France located in Agen and a committed brand, present with patients and pharmacists for 90 years.

As the largest private employer in Lot-et-Garonne, the company brings together 1,941 employees and generates 2,500 indirect jobs. Present in 63 countries, UPSA exports more than 60% of its volumes internationally every year from Agen. Since 2021, UPSA has been engaged in a strategic plan - Conquest 2027 - aimed at sustainably supporting the growth and development of the company. In 2024, UPSA achieved a revenue of 501 million euros. In September 2024, UPSA received the B Corp certification, which recognizes companies meeting high standards of social and environmental performance, transparency, and accountability – making it one of the three pioneering companies in France to be certified in the health industry.

Main activities

The Global Regulatory Affairs (GRA) EU Coordinator reports to the Innovation & EU Regulatory Affairs Director. The EU Coordinator plays a central role in ensuring smooth coordination, planning, and execution of regulatory activities.

Regulatory Project Coordination (EU scope)

• Lead the end-to-end global planning of maintenance activities related to EU procedures: oversight, tracking, workload distribution, and timely submissions.
• Prepare and manage the review of common documentation packages with all relevant stakeholders, per plan.
• Ensure accurate data entry, tracking, and follow-up in the RIM tool for preparation, submission, responses to authority questions, and final European approvals.
• Guarantee clear communication flows and systematic archiving of regulatory activities.
• Contribute to the development, update, and optimization of related processes, procedural documents, and training materials.
• Support critical data review and compliance analysis for MRP/DCP/WS/SG procedures.
• Collaborate with the Global Operations Team to ensure the accuracy, completeness, and compliance of MRP/DCP registration data in line with RIM requirements and EU regulatory standards (IDMP...).

EU Regulatory Affairs Department Support

• Monitor and report KPIs for EU Regulatory activities.
• Support the onboarding and training of newcomers within the department.
• Coordinate budget tracking, vendor contracts, and related administrative follow-up.
• Organize and facilitate team meetings, workshops, and cross-functional exchanges, including the preparation and distribution of meeting minutes.

The status of this position is non-executive.

Requirements

• 10 years experience in similar experience in Regulatory Affairs with exposure to EU procedures (NP, MRP, DCP, WS, SG).
• Solid knowledge and hands-on experience with RIM systems.
• French & English fluency (both written & spoken).
• Proficiency with standard IT tools (Word, Excel, PowerPoint, Outlook, SharePoint).
• Previous experience in budget and vendor management is a plus.
• Strong organizational and coordination abilities with a reliable sense of urgency and prioritization.
• Ability to lead and communicate cross-functionally.
• Ability to work both independently and collaboratively, demonstrating initiative and problem-solving.
• Proactive, curious and dynamic.
• Pragmatic, agile, team spirit.
• Open communication.