Director, Regulatory Affairs, Europe

Revolution Medicines seeks a Director of Regulatory Affairs for Europe to lead regulatory strategy and MAA filings for oncology programs in Basel.

This position sits within the growing European division of Revolution Medicines and reports directly to the Senior Director of Regulatory Affairs, Europe. The company focuses on late-stage clinical oncology, creating targeted therapies for patients with RAS-addicted cancers. The primary purpose of this role is to define and deliver the regulatory strategy for specific programs under RevMed's portfolio.

Responsibilities

• Manage the full lifecycle of Marketing Authorisation Application (MAA) filings across the EU, EEA, UK, and Switzerland for oncology products.
• Align European regulatory strategies with the broader global and regional company goals.
• Represent the regulatory affairs function on global and regional cross-functional teams.
• Engage proactively with health authorities such as the EMA, MHRA, and Swissmedic to secure positive regulatory outcomes.
• Plan and execute regulatory pathways for MAAs and manage lifecycle activities within the European region.
• Lead regional regulatory planning, including integrated filing plans, timelines, and critical path activities, in coordination with the Global Regulatory Team.
• Coordinate MAA submissions, ensuring dossier readiness, cross-functional alignment, and governance for management approval.
• Act as the main point of contact for European health authorities, including the EMA and national agencies, managing all communications.
• Prepare and review key regulatory documents, including Scientific Advice Briefing Packages, Orphan Designation Applications, and Paediatric Investigation Plans.
• Identify and mitigate regulatory risks that could affect timelines or outcomes, reporting progress to senior leadership.
• Collaborate with global regulatory leads to ensure consistency between global and regional strategies.
• Partner with R&D, Medical Affairs, Safety, Market Access, and Commercial teams as a strategic advisor.
• Ensure adherence to European regulatory, pharmacovigilance, and governance standards.
• Monitor evolving European regulatory guidelines and communicate their impact to relevant functions.
• Oversee external vendors and CROs to ensure high-quality and timely regulatory submissions.

Requirements

• Degree in biological or life sciences, pharmacy, medicine, or a related field.
• At least 10 years of experience in the pharmaceutical or biotech industry.
• Minimum of 8 years in Regulatory Affairs, including experience in a regulatory strategy role.
• Comprehensive knowledge of European regulatory frameworks and oncology guidelines.
• Proven track record of successful EMA/MHRA submissions, including experience with MAAs, Paediatric, and Orphan Designations.
• Hands-on experience preparing and submitting complex regulatory documentation for health agency review and post-approval activities.
• Experience interacting with the EMA and other European regulatory agencies.
• Demonstrated ability in strategic problem-solving with health agencies and leading internal teams on regulatory strategy.
• Experience representing Regulatory Affairs on cross-functional teams and presenting to senior management.
• Strong interpersonal, written, and presentation skills, with the ability to communicate complex regulatory strategies to diverse audiences.
• Ability to thrive in a fast-paced, dynamic environment and manage multiple tasks independently with limited supervision.
• Excellent planning, organizational, and project management skills, with the ability to handle multiple projects under tight deadlines.
• Strong leadership, communication, and stakeholder management capabilities.

Nice to have

• An advanced degree such as a PhD, PharmD, or MSc is desirable.
• Significant experience in oncology drug development is highly preferred.

About the company

Revolution Medicines is a late-stage clinical oncology company dedicated to developing novel targeted therapies for patients with RAS-addicted cancers. The organization is committed to addressing the needs of patients with cancers harboring mutations in the RAS signaling pathway. The company also places a high priority on the protection and security of personal data, respecting employee privacy rights.

• Commitment to patients with cancers harboring mutations in the RAS signaling pathway.
• Strong emphasis on the protection and security of personal data and respect for privacy rights.