GLOBAL REGULATORY AFFAIRS EU COORDINATOR (M/W)

Description du poste et des missions

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.

With its range of self-medication products and medical devices, UPSA enables patients to treat common everyday ailments. Its expertise covers six therapeutic areas: pain and fever (historical specialty), Cough & Cold and respiratory issues, digestion, sleep disorders, vitality, and women's health. UPSA embodies regional roots and the defense of a "Made in France" know-how that resonates internationally.

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, primarily in Europe, French-speaking Africa, China, and Vietnam, 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

Lieu de la mission