UPSA

Project Manager

• Provide regulatory expertise to obtain European marketing authorizations.
• Implement the regulatory strategy decisions defined in the Global Regulatory Plan.
• Draft the European Module 1 and coordinate the preparation of complete dossiers with global functions and regional and local regulatory teams.
• Independently manage straightforward European procedures.
• Lead regulatory activities related to worksharing and supergrouping variations.
• Coordinate multiple complex European projects in parallel, covering pharmaceutical and clinical variations.
• Supervise regional and local partners on specific cross-functional activities.
• Manage European regulatory data and documents in UPSA’s internal systems, particularly RIM.
• Monitor European regulatory developments relating to medicinal products.
• Ensure compliance with local regulatory requirements and UPSA policies and procedures.
• Support junior staff, including interns and apprentices.
• Provide backup, as needed, for the Global Regulatory Affairs Core Team Lead on cross-functional R&D projects and lifecycle management topics.
• Develop collaborative relationships with regional stakeholders to ensure alignment and execution of regulatory activities.

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Global Regulatory Affairs Project Manager