Regulatory Affairs Manager

Location:
Zurich (Hybrid)
Duration:
6-month maternity cover
Contract Period:
…
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