Director Regulatory Affairs Labelling

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.

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