[Hiring] Global Regulatory Affairs Project Manager @UPSA

Role Description

Reporting to the Director of Regulatory Affairs & Innovation, the Global Regulatory Affairs Project Manager operates across an international scope, with a strong focus on European regulatory procedures.

• European procedures
  • New European MAA Marketing Authorization registration dossiers (MRP/DCP/RUP):
    • Provide regulatory expertise to allow EU registrations in the best conditions.
    • Execute regulatory strategic decisions according to Global Regulatory Plan.
    • Prepare EU Module 1 and coordinate full dossier development with global functions and regional/local regulatory teams.
    • Run simple EU procedures in autonomy.
  • Lifecycle Management of the worksharing & supergrouping variations dossiers:
    • Supervise the regulatory processes in line with business/R&D objectives to ensure timely registration of life-cycle management (LCM) of products.
    • Coordinate in autonomy lifecycle management activities, including complex and parallel EU projects (e.g., Worksharing, Supergrouping…) for pharmaceutical and clinical variations.
    • Supervise Regional/Local partners for specific transversal activities.
    • Manage European regulatory data and documentation within UPSA internal systems, ensuring readiness, publishing, and accurate tracking (RIM).
    • Ensure regulatory intelligence related to Drug products for Europe.
    • Ensure compliance with local regulatory requirements and UPSA policies and procedures.
    • May supervise junior team members (e.g. trainees, apprentices).
• Innovation
  • Could act as a Global Regulatory Affairs Core Team member backup supporting transversal R&D projects on minor molecules and lifecycle management (LCM) topics.
  • Develop strong, collaborative relationships with regional stakeholders to ensure regulatory alignment and execution.

Qualifications

• Pharmacist, bachelor's degree in science (chemistry, biology, life-science…).
• Master 2 in Regulatory Affairs.
• Minimum 3 years of similar experience in Regulatory Affairs with proven records on EU procedures.
• Fluent in English and French.
• Proficiency in computer tools: Word, Excel, RIM, eDMS (GED/Publishing).
• International registration exposure would be an additional asset.
• A business-oriented mindset with strong problem-solving skills.
• Ability to work independently and manage multiple priorities.
• Clear, open communication style and a collaborative spirit.
• Analytical, detail-oriented, and proactive approach to challenges.

Benefits

• Close-knit and passionate teams.
• Career development opportunities within a fast-growing company.
• A strong social policy that puts employee well-being at the heart of our priorities.