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Manager Regulatory Affairs
Posted 12 hours 26 minutes ago by Swisslinx
Permanent
Not Specified
Government & Defence Jobs
Zürich, Zürich, Switzerland
Job Description
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
- 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
Swisslinx
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