Manager Regulatory Affairs

Job description:

• Lead and support regulatory activities for assigned assets/projects
• Present regional strategies to senior management
• Monitor and interpret regional regulations affecting development and compliance
• Provide expertise across development, registration, post-marketing, and life-cycle management
• Review legislation, internal procedures, and fulfil post-marketing commitments
• Build cross-functional and external partnerships to support access strategies
• Communicate plans, timelines, and risks; ensure timely submissions/approvals
• Prepare for and participate in Health Authority meetings and manage follow-up

Requirements:

• BSc/BA in a scientific field (advanced degree preferred)
• 4+ years in drug regulatory affairs, ideally in EU/GEM markets
• Knowledge of regulations for drugs/biologics across all development phases; skilled in Health Authority interactions
• Advantage: experience with advanced therapies (cell & gene)
• Strong analytical skills, attention to detail, and sound recommendations
• Promotes inclusivity, empathy, and effective communication
• Adapts well to change, builds strong relationships, and meets deadlines
• Self-aware, resilient, and able to manage multiple challenges with energy and confidence

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