Director, EU Regulatory Labelling Strategy

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

Zusammenfassung

subrosa Health & Capital group seeks a Director of 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 and oncology programs.

You will head cross‑functional collaboration with Global RA, Clinical, Safety, Medical and Commercial teams and drive submissions and updates with regulatory authorities

Qualifikationen

• 10+ years in pharma/biotech with regulatory affairs experience in labelling.
• Strong knowledge of EU labelling requirements (SmPC/PL) and EMA processes.
• Oncology experience preferred.

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 strategy

Cross-functional leadership

Communication

EMA procedures

Jobbeschreibung

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 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