Founded in 1935, UPSA is today both a mid-sized company with one of the largest pharmaceutical industrial sites in France located in Agenand 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 :
Innovation :
- Act as a trusted partner of Global Business counterparts with Upper Management direct strategic exposure.
- Lead the development of the Global Regulatory Strategy & Planning, aligning it seamlessly with the Global Portfolio vision.
- Build strong partnerships with regional offices to ensure regulatory alignment and smooth operational roll-out of projects.
- In close collaboration with regional offices, translate complex country-specific regulatory landscapes into actionable global strategies and execution plans.
- Lead, for Scientific Affairs group, parallel due diligence review to support new products/countries entries.
- Represent the Scientific Affairs team in strategic core teams, providing expert regulatory & Scientific affairs guidance to optimize market access.
- Supports geographical expansion as needed, by defining best countries entries.
- Advocate UPSA’s interests in European pharmaceutical trade associations (e.g., AESGP), influencing regulatory evolution
European procedures :
- Define best EU entry strategies and manage effectively EU HA interactions in the frame of MRP/DCP forthcoming applications.
- Lead regulatory activities for new product/molecules launches in Europe, making decisive calls on filing readiness.
- EU Project Budget handling.
- Collaborate with Global CMC and R&D teams to ensure regulatory documentation is complete, compliant, and submission-ready.
- Partner with Global labelling to ensure labelling updates are communicated on time and implemented appropriately in the markets.
- Drive regulatory processes to support timely approvals, lifecycle management, and renewals across UPSA’s EU portfolio.
- Ensure full regulatory compliance for products registered via European procedures.
- Continuously optimize and adapt Global/EU regulatory processes for enhanced efficiency and simplification.
- May lead regulatory teams or oversee multiple high-impact project teams.
Requirements
- Pharmacist, bachelor’s degree in science (chemistry, biology, life-science…).
- Master 2 in Regulatory Affairs.
- Minimum 8 years of similar experience in Regulatory Affairs with minimum 5 years of significant proven experience in the above-mentioned missions for EU procedures.
- Successful experiences in management or in multiple projects management.
- Fluent in English and French.
- Knowledge of RIM and eDMS (GED/Publishing).
- Medical Devices and/or food supplements experience would be a plus.
- Integrity-driven, adaptable, and a proactive team player.
- Strong problem-solving mindset with innovation focus.
- Excellent interpersonal communication/negotiation and organizational skills.
- Business-oriented
- Boldly challenges the status quo to drive progress.
- Proven ability to build alignment and lead cross-functional collaboration.
- Demonstrated ability to coordinate team in a time intensive situation.
- Demonstrated ability to multi-task, manage competing priorities (i.e. working on many projects with overlapping timelines).
- Demonstrated successful external influencing involving professional associations and Health Authorities. Anticipation/Interpretation of EU and international legislation evolution to propose company evolutions.