Vice President, Regulatory Affairs, Europe

Head Of Regulatory Affairs, Europe

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity :

The Head of Regulatory Affairs, Europe, will lead the regulatory organization supporting the Europe region and the region regulatory strategy and execution for the company's portfolio. This position reports to Global Regulatory Affairs and dotted line to the SVP, Head of Europe.

Provide ethical and mission-driven leadership and practice the company's mission-driven culture. Ensure that RevMed core values guide the strategic vision and our day-to-day decision making and teamwork in Europe.

Work closely with the EU and Country teams to provide an aligned vision for the Regulatory Affairs Europe team and develop a plan to achieve it. Design and rapidly scale to meet the needs of the region.

Align and coordinate with global functions to ensure European and key country requirements and / or perspective is represented throughout the product lifecycle.

Help define the scope and clarity of roles and responsibilities between global and regional regulatory teams.

Drive health authority and related interactions, ensuring timely approvals and appropriate lifecycle management of products across Europe.

Ensure high-quality, well-vetted, relevant regulatory research, strategies and advice are provided to project teams, working groups, the European and Country teams as well as Global Regulatory Leads.

Influence decision-making in Europe and with global regulatory and company leadership.

Collaborate closely and form productive relationships with other functional and regional heads to ensure high quality, cross-functionally sound decision-making.

Ensure consistency in approach (one playbook) and that learning occurs across the team.

Actively lead the function and support team member development.

Required Skills, Experience and Education :

Located in EU or UK.

BA / BS degree in life sciences or related disciplines.

At least 15 years of experience in drug regulatory affairs with direct European experience.

Minimum of 8 years of experience in regulatory leadership / executive role including significant oncology / hematology experience.

Proven experience in building regulatory strategy for global oncology organization.

Expertise in navigating global regulatory submissions and negotiations in a commercial setting.

Ability to successfully work in a fast-paced, demanding and highly cross-functional environment.

Experience scaling an organization rapidly.

Clearly understands the role of regulatory affairs in drug development and global commercialization, and is comfortable with ambiguity, risk, and optimizing strategies for business needs.

Preferred Skills :

Advanced degree in life sciences enabling technical fluency in oncology.

Prior senior regulatory executive in oncology drug development at a medium or large pharmaceutical enterprise but who also understands the startup environment.