Director, Regulatory Affairs Labelling, Europe

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:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Required Skills, Experience and Education:

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

• 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.

• Significant experience with oncology drug development highly preferred.

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

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

• Strong understanding of EU regulatory framework and labelling guidelines.

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

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

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

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

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

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

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Hybrid #LI-LO1