Director, Regulatory Affairs Labelling, Europe

Revolution Medicines seeks a Director of Regulatory Affairs Labelling for Europe to lead EU, UK, and Swiss labelling strategy, ensuring compliance and alignment with global regulatory goals.

This position serves as the primary subject matter expert for European labelling, reporting directly to the Senior Director of Regulatory Affairs in Europe. The role is responsible for driving the cross-functional development and execution of regional labelling strategies, with a specific focus on the EU/EEA, UK, and Switzerland. The incumbent leads labelling activities across both development and post-approval phases, ensuring that regional requirements are met while supporting broader regulatory submissions and lifecycle management efforts.

Responsibilities

• Develop and execute labelling strategies for the EU that align with global regulatory objectives.
• Manage the creation of high-quality labelling documents, including Product Information for the EU, UK, and Switzerland.
• Provide regional input for target and core labelling documents.
• Oversee user testing of EU Package Leaflets and manage the translation of labelling materials.
• Ensure consistency between core labelling and regional EU-specific content.
• Advise internal teams on EMA and regional labelling requirements as the designated SME.
• Collaborate with Global RA, Clinical, Safety, Medical Affairs, and Commercial teams to refine regional content.
• Interface with the EMA, rapporteurs, and national competent authorities regarding labelling issues.
• Conduct competitive intelligence and benchmarking of EU labelling within the oncology space.
• Monitor changes in EU regulatory requirements and assess their impact on labelling processes.
• Ensure quality through rigorous review, proofreading, and quality control of labelling deliverables.
• Communicate approved labelling updates to relevant stakeholders.
• Maintain version control and compliant documentation for all labelling changes.
• Contribute to the improvement of global labelling processes, tools, and policies.
• Oversee external vendors and CROs to ensure timely and high-quality regulatory submissions.

Requirements

• Degree in biological sciences, life sciences, pharmacy, medicine, or a related field.
• Minimum of 10 years of experience in the pharmaceutical or biotech industry.
• At least 8 years in Regulatory Affairs, including experience in a labelling role.
• Proven experience managing EU labelling (SmPC/PL) and familiarity with EMA procedures.
• Experience developing and maintaining product labelling across multiple regions (EU/EEA, MHRA, Swissmedic).
• Strong understanding of the EU regulatory framework and labelling guidelines.
• Experience interacting with the EMA and other European agencies on labelling negotiations.
• Demonstrated strategic problem-solving skills with health agencies and experience leading internal teams.
• Experience representing Regulatory Affairs on cross-functional teams and presenting to senior management.
• Excellent interpersonal, written, and presentation skills.
• Ability to communicate complex regulatory strategies to diverse audiences.
• Thrives in a fast-paced, dynamic environment and can multitask independently.
• Strong planning and organizational skills.
• Ability to manage multiple projects with tight deadlines simultaneously.

Nice to have

• Advanced degree (PhD, PharmD, MSc) is desirable.
• Significant experience in oncology drug development is highly preferred.

About the company

Revolution Medicines is a late-stage clinical oncology company focused on developing novel targeted therapies for patients with RAS-addicted cancers. The team is deeply committed to serving patients with cancers harboring mutations in the RAS signaling pathway.

• Focus on developing novel targeted therapies for RAS-addicted cancers.
• Commitment to patients with cancers harboring mutations in the RAS signaling pathway.