Director, Regulatory Affairs Labelling – Europe

About the role

Revolution Medicines is seeking a Director of Regulatory Affairs Labelling for Europe to lead the development and execution of regional labelling strategy across the EU/EEA, UK and Switzerland. The role will ensure compliance with EMA and national authority requirements while aligning with global labelling initiatives.

Key responsibilities

• Develop and execute EU labelling strategy in line with global regulatory plans.
• Prepare high‑quality labelling documents, including EU/UK/Swiss product information and oversee user testing and translations.
• Serve as the EU labelling subject‑matter expert, advising internal teams on EMA and regional guidelines.
• Drive labelling support for regulatory submissions such as MAAs, variations and renewals.
• Interface with EMA, rapporteurs and national competent authorities on labelling negotiations and queries.
• Conduct competitive intelligence and monitor evolving EU regulatory requirements.

Required profile

• Degree in life sciences, pharmacy, medicine or related field; advanced degree (PhD, PharmD, MSc) desirable.
• Minimum 10 years industry experience with at least 8 years in Regulatory Affairs, including a labelling focus.
• Extensive experience with oncology drug development and EU labelling (SmPC/PL).
• Proven track record of interacting with EMA, MHRA and Swissmedic on labelling matters.
• Strong communication, planning and organizational skills, able to work independently in a fast‑paced environment.

Required skills

• EU labelling (SmPC/PL) preparation and management.
• EMA procedures and regulatory submission processes (MAA, variations, renewals).
• Product information documentation and translation oversight.
• Strategic labelling development and lifecycle management.
• Direct interactions with EMA, MHRA and Swissmedic.