Category
Accounting/Finance
Description
Job description:Location: Zurich (Hybrid)
Duration: 6-month maternity cover
Contract Period: 02/03/2026 - 31/08/2026, 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
Job ID: 81481771
