Director, Regulatory Affairs Labelling, Europe

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Opportunity

As part of our expanding European organization, we seek a Director, Regulatory Affairs Labelling, Europe who will drive cross-functional development and execution of regional labelling strategy with a primary focus on EU/EEA, UK, and Switzerland for designated programs.

This individual will lead EU labelling strategy and execution across development and post-approval phases, ensuring compliance with EMA and national competent authority requirements, while maintaining alignment with global labelling.

They will independently represent European labelling on global and regional cross-functional teams, delivering targeted, strategic and actionable labelling guidance for oncology programs across one or more therapeutic areas.

The candidate must have a thorough understanding of oncology drug development, applicable European regulations and is responsible for driving labelling interactions with health authorities including the EMA/MHRA/Swissmedic ensuring successful regulatory outcomes.

The role will report to the Senior Director, Regulatory Affairs, Europe.

Primary Responsibilities

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Lead the development and execution of EU labelling strategy in alignment with global regulatory strategy.

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Manage the preparation of high-quality labelling documents, including: EU/UK/Swiss Product Information.

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Contribute to target and core labelling documents from a regional perspective, as applicable.

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Oversight of EU PL user testing and translations of EU labelling documents.

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In partnership with Global RA Labelling, ensure consistency and alignment between core labelling and regional (EU) labelling.

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Serve as the EU labelling subject matter expert, advising internal stakeholders on EMA and regional labelling requirements, guidelines, and trends.

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Collaborate with Global RA Labelling, Clinical, Safety, Medical Affairs, Commercial, and other functions to develop and refine regional labelling content.

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Drive labelling strategy to support regulatory submissions (e.g., MAA, variations, renewals) and lifecycle management activities in Europe.

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Interface with EMA, rapporteurs, and national competent authorities on labelling-related matters, including negotiations and responses to regulatory questions.

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Conduct competitive intelligence and benchmarking of EU labelling within the therapeutic area to inform strategy and positioning.

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Monitor evolving EU regulatory requirements and assess impact on labelling strategy and processes.

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Ensure high-quality EU labelling deliverables through rigorous review, proofreading, and quality control processes.

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Oversee implementation and communication of approved EU labelling updates to relevant stakeholders.

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Maintain compliant documentation and version control for all EU labelling changes.

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Contribute to the development and continuous improvement of global labelling processes, tools, and policies.

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Oversee external vendors and CROs to ensure timely, high-quality regulatory submissions and approvals.

Required Skills, Experience and Education

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Degree in biological or life sciences, pharmacy, medicine, or related fields. An advanced degree (PhD, PharmD, MSc) is desirable.

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A minimum of 10 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a relevant labelling role.

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Significant experience with oncology drug development highly preferred.

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Demonstrated experience managing EU labelling (SmPC/PL) and familiarity with EMA procedures.

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Proven experience developing and maintaining product labelling across multiple regions (e.g., EU/EEA/MHRA/Swissmedic).

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Strong understanding of EU regulatory framework and labelling guidelines.

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Experience interacting with the EMA and other European agencies on labelling negotiations.

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Demonstrated experience in strategic problem-solving with health agencies and leading internal teams on regulatory strategy.

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Experience in representing Regulatory Affairs on cross-functional teams and presenting to senior management.

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Excellent interpersonal, written, and presentation skills with the ability to effectively communicate complex regulatory strategies to diverse audiences.

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Thrives in fast-paced, dynamic environment and ability to multi-task independently with limited supervision.

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Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.

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