Director, EU Regulatory Labelling Strategy

subrosa Health & Capital group; Basel; Vor Ort; CHF 180.000 - 260.000; Vollzeit

Zusammenfassung

subrosa Health & Capital group is seeking a Director, Regulatory Affairs Labelling to lead regional labelling strategy across EU/EEA, UK and Switzerland. You will shape and execute labelling from development through post-approval, ensuring EMA and national authority compliance while aligning with global CCDS.

You will represent European labelling on global teams and guide oncology programs in a fast-scaling environment, collaborating with Global RA, Clinical, Safety and Commercial teams.

Qualifikationen

• 10+ years in pharma/biotech with a labelling focus.
• 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 with excellent communication in a fast-growing environment.

Aufgaben

• 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 Swissmedic.
• Ensure rigorous quality, version control and compliant implementation of updates.

Kenntnisse

Regulatory Affairs

Labelling

EU Regulatory

Cross-functional Leadership

EMA/Swissmedic

Oncology

Jobbeschreibung

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 Swissmedic
• Ensure rigorous quality, version control and compliant implementation of updates

What You Bring

• 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

If this role resonates with your experience and ambitions, we welcome your interest and look forward to hearing from you.