Global Regulatory Affairs Manager (M/W)

UPSA; Rueil-Malmaison; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

UPSA, une entreprise pharmaceutique française, recherche un Responsable des Affaires Réglementaires. Le candidat devra développer des stratégies réglementaires, gérer des projets complexes et travailler en collaboration avec les équipes existentes tout en étant un leader proactif dans le domaine. Ce poste exige une solide expérience en affaires réglementaires et une bonne maîtrise de l'anglais.

Qualifications

• Minimum 8 ans d'expérience en affaires réglementaires.
• Expérience réussie en gestion de plusieurs projets.
• Fluent en anglais et en français.

Responsabilités

• Développer des stratégies réglementaires et gérer les applications MRP/DCP.
• Collaborer avec les équipes mondiales pour assurer la conformité réglementaire.
• Diriger les activités réglementaires pour le lancement de nouveaux produits en Europe.

Connaissances

Communication interpersonnelle

Résolution de problèmes

Gestion de projets

Négociation

Formation

Pharmacien

Master 2 en Affaires Réglementaires

Outils

RIM

eDMS (GED/Publishing)

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 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.