Senior Director, Regulatory Affairs, Europe

The Opportunity:

As part of our expanding European organization, we seek a strategic and hands-on Senior Director, Regulatory Affairs, Europe who will play a critical role in leading and executing the regional regulatory strategy for our portfolio across the EU, EEA, UK and Switzerland.

The Senior Director will serve as a strategic partner to Global Regulatory Teams, ensuring alignment of the European regulatory strategy with the global and regional company`s objectives.

They will independently represent regulatory affairs in global and regional cross-functional teams and provide targeted, strategic expertise of one or more therapeutic areas for oncology programs across the Global and European organization.

The Senior Director will lead the Regional Regulatory Affairs Team, foster the career development of direct reports and contribute to departmental leadership activities.

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

The role will report to the VP, Head of Regulatory Affairs, Europe.

Primary Responsibilities:

• Lead the development and execution of regional regulatory strategy for assigned programs across all stages of development (early development through post-approval) supporting global and regional goals.

• Develop, plan and execute regulatory pathways for Marketing Authorisation Applications, and lifecycle management activities in the European Region.

• Ensure regulatory submissions meet regulatory requirements and timelines.

• Serve as primary contact for regulatory interactions with the European Agencies, e.g. (EMA, other national competent authorities across the EU/EEA.

• Lead the preparations, provide regional regulatory expertise, and review Scientific Advice Briefing Packages, Orphan Designation Applications, Paediatric Plans.

• Lead EMA, Rapporteur(s), Oral Explanations and other Health Authorities`interaction.

• Provide regional regulatory input to clinical trial design, labelling strategy, post-marketing activities and commitments.

• Partner with global regulatory leads to ensure alignment between global and regional strategies.

• Provide and incorporate regional regulatory, clinical, and market insights into integrated disease area and product strategies.

• Act as a strategic partner to R&D, medical affairs, safety, market access, and commercial global and regional teams.

• Ensure compliance with all applicable regulatory, pharmacovigilance, and medical governance requirements.

• Identify, assess and communicate cross-functionally impact of relevant European regulatory requirements, guidelines and trends.

• Oversee and accountable for working with outside vendors and Contract Research Organisations (CROs) to ensure timely submissions and approvals of assigned products.

• Provide managerial leadership & direction to direct reports allowing appropriate prioritization of resources to achieve corporate and regional goals.

• Provide coaching, mentoring, and development of direct reports, ensuring staff are compliant with Revolution Medicine’s corporate and departmental policies and procedures.

Required Skills, Experience and Education:

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

• 12+ years of regulatory affairs experience in the pharmaceutical or biotech industry.

• Significant experience with oncology drug development and checkpoint inhibitors highly preferred.

• Deep understanding of European regulatory frameworks and oncology guidelines.

• Demonstrated success in EMA/MHRA submissions and approvals, including but not limited to MAA , Paediatric, Orphan Designations experience.

• Direct hands-on experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities.

• Experience interacting with the EMA and other European agencies.

• 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.

• Excellent leadership, communication and stakeholder management skills.

• Strong project management and organizational skills.

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