Regulatory Affairs Manager

Job description:

Location: Zurich (Hybrid)

Duration: 6-month maternity cover

Contract Period: 02/03 08/2026, potential extension

Start: 02/03/2026

Workload: 100%

Requirements:

• Support regulatory activities for vaccine development, registration and lifecycle management in Europe
• Manage assigned regulatory projects, including preparation and maintenance of dossier components, MAA submissions, variations and lifecycle updates
• Oversee regulatory aspects of clinical trials in the region
• Collaborate with global, regional and local Takeda Regulatory Affairs teams to ensure alignment with global strategy
• Prepare, compile and deliver CTD Module 1 components according to regional requirements
• Support local submissions and label development; ensure right-first-time filings
• Ensure compliance with internal SOPs and regional regulatory requirements
• Assist in preparing materials for Health Authority interactions
• Manage and maintain regulatory archives and documentation in the EDMS
• Track regulatory activities and commitments in Takeda systems
• Actively participate in global regulatory team activities and support project planning and execution

Competences:

• Bachelor's degree preferred
• Minimum 6 years of pharmaceutical industry experience, with at least 3 years in Regulatory Affairs (vaccines or biologics experience essential)
• Experience with EMA submissions and/or centralized procedure filings
• Experience supporting or contributing to global regulatory filings is a plus
• Ability to interpret scientific information and apply regulatory requirements strategically
• Excellent English communication skills (written and verbal)
• Highly organized, detail-focused and reliable in meeting timelines
• Strong collaboration skills and ability to work across global, regional and local teams
• Proactive, solution-oriented and quality-focused working style

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