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Director, EU Regulatory Labelling Strategy
Job in
4040, Basel, Kanton Basel-Landschaft, Switzerland
Listed on 2026-09-21
Listing for:
subrosa Health & Capital group
Full Time
position Listed on 2026-09-21
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist -
Management
Regulatory Compliance Specialist
Job Description & How to Apply Below
Location: Switzerland (Hybrid)
Function: Regulatory Affairs – Labelling
Level: Director
A rapidly emerging biotech with strong scientific momentum is expanding its European footprint and seeking a Director, Regulatory Affairs Labelling to lead regional labelling strategy across EU/EEA, UK and Switzerland
.
In this high‑visibility role, you will shape and execute labelling strategy from development through post‑approval, ensuring compliance with EMA and national authorities while maintaining alignment with global CCDS. You will represent European labelling on global teams and provide strategic, actionable guidance for oncology programs in a fast‑scaling environment.
Key Responsibilities- Lead EU/UK/CH labelling strategy and lifecycle execution
- Develop and maintain high‑quality Product Information (SmPC/PL)
- Align regional labelling with global CCDS and target/core labelling
- Partner cross‑functionally with Global RA, Clinical, Safety, Medical and Commercial
- Support regulatory submissions (MAA, variations, renewals)
- Drive labelling discussions with EMA, MHRA and Swiss medic
- Ensure rigorous quality, version control and compliant implementation of updates
- 10+ years in pharma/biotech, incl. 8+ years in Regulatory Affairs with labelling focus
- Strong experience with EU labelling (SmPC/PL) and EMA procedures
- Oncology experience strongly preferred
- Proven ability to lead cross‑functional teams and navigate health authority interactions
- Strategic mindset, excellent communication skills, and comfort in a dynamic, fast‑growing environment
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