Director, Regulatory Affairs Labelling, Europe

Revolution Medicines seeks a Director of Regulatory Affairs Labelling for Europe to lead labelling strategy and execution across EU/EEA, UK, and Switzerland for oncology programs. The role involves managing regulatory interactions with the EMA and national authorities, ensuring compliance with regional requirements while maintaining global alignment.

Responsibilities

• Develop and execute EU labelling strategy aligned with global regulatory approach
• Prepare and oversee high-quality labelling documents for EU, UK, and Swiss submissions
• Serve as regional labelling subject matter expert, advising internal teams on regulatory requirements
• Interface with EMA, rapporteurs, and national competent authorities on labelling matters
• Conduct competitive benchmarking and monitor evolving EU regulatory requirements for impact assessment

Requirements

• Extensive experience in oncology drug development and European regulatory affairs
• Deep knowledge of EMA guidelines, UK MHRA, and Swissmedic labelling requirements
• Proven expertise in managing labelling strategy across development and post-approval phases
• Strong cross-functional collaboration and stakeholder management experience
• Experience representing regulatory positions in interactions with health authorities
• Demonstrated ability to lead labelling document preparation and quality assurance