Director, Regulatory Affairs, Europe

Das ist der Job

The company's RD pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins.

Darum lohnt es sich

The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi‑selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C‑selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D‑selective inhibitor; and RMC‑5127, a RAS(ON) G12V‑selective inhibitor are currently in clinical development.As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.The OpportunityAs part of our expanding European organization, we seek a strategic and hands‑on Director, Regulatory Affairs, Europe who will be responsible for the delivery of regulatory strategy for designated programs at RevMed.

They are accountable for driving preparation and end‑to‑end execution of regulatory MAA filings across the EU, EEA, UK and Switzerland for oncology programs, ensuring alignment of the European regulatory strategy with the global and regional company’s objectives.They will independently represent regulatory affairs on global and regional cross‑functional teams, delivering targeted, strategic and actionable regulatory 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 proactive engagement with health authorities including the EMA, MHRA and Swissmedic ensuring successful regulatory outcomes.The role will report to the Senior Director, Regulatory Affairs, Europe.ResponsibilitiesDevelop, plan and execute regulatory pathways for Marketing Authorisation Applications and lifecycle management activities in the European Region.Develop and execute European regulatory strategies for Marketing Authorisation Applications (MAAs) and lifecycle management activities.Lead regional regulatory planning and oversee integrated filing plans, including timelines, deliverables, and critical path activities, in collaboration with the Global Regulatory Team.Direct and coordinate MAA submissions, including dossier readiness, cross‑functional alignment and governance for management endorsement.Serve as the primary regulatory liaison with European health authorities (e.g., EMA and EU/EEA national agencies), leading all interactions and communications.Lead preparation and review of key regulatory submissions, including Scientific Advice Briefing Packages, Orphan Designation Applications and Paediatric Investigation Plans.Identify, assess and proactively mitigate regulatory risks impacting timelines or outcomes; communicate progress and risks to senior leadership.Partner with global regulatory leads to ensure alignment between global and regional regulatory strategies.Act as a strategic partner to cross‑functional teams, including RD, Medical Affairs, Safety, Market Access and Commercial.Ensure compliance with applicable European regulatory, pharmacovigilance and governance requirements.Monitor and interpret evolving European regulatory requirements, guidelines and trends, and communicate their impact across functions.Oversee external vendors and CROs to ensure timely, high‑quality regulatory submissions and approvals.QualificationsDegree 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 regulatory strategy role.Significant experience with oncology drug development highly preferred.Deep understanding of European regulatory frameworks and oncology guidelines.Demonstrated success in EMA, MHRA and Swissmedic submissions and approvals, including but not limited to MAA, Paediatric and Orphan Designation experience.Direct hands‑on experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures and 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 a fast‑paced, dynamic environment and can multi‑task independently with limited supervision.Excellent planning and organizational skills and the ability to work simultaneously across multiple priorities.

OverviewRevolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS‑addicted cancers.