Associate Director, Regulatory Affairs, Europe

Revolution Medicines; Basel; Vor Ort; CHF 130.000 - 190.000; Vollzeit

Zusammenfassung

Revolution Medicines seeks an Associate Director, Regulatory Affairs, Europe to provide strategic regulatory leadership for designated oncology programs across Europe, the EU/EEA, UK and Switzerland. You will align regulatory plans with global goals and drive end-to-end MAA filings while engaging with EMA, MHRA and Swissmedic.

You will lead cross‑functional teams, assess regulatory risks, and ensure timely, high‑quality submissions across complex programs in a fast-paced environment.

Qualifikationen

• Degree in biological or life sciences, pharmacy, medicine, or related fields. An advanced degree (PhD, PharmD, MSc) is desirable.
• A minimum of 8 years in the pharmaceutical/biotech industry and at least 7 years in Regulatory Affairs including strategy roles.
• Significant oncology drug development experience and strong EMA/MHRA submission history.
• Hands-on experience with large, complex regulatory documentation and health agency interactions.
• Ability to lead cross-functional teams and communicate regulatory strategies to senior management.

Aufgaben

• Lead regulatory strategy for assigned oncology programs in Europe, aligning with global objectives.
• Plan, prepare and coordinate MAA submissions and lifecycle activities across EU/EEA/UK/Switzerland.
• Act as primary regulatory liaison with EMA, MHRA and Swissmedic as applicable.
• Coordinate deadlines, dossiers, and cross‑functional alignment for regulatory filings.
• Identify regulatory risks and communicate impact to leadership; manage vendor relationships.

Kenntnisse

Regulatory strategy

EMA/MHRA submissions

Oncology drug development

European regulatory framework

Cross-functional leadership

Regulatory submissions

Stakeholder management

Project management

Communication skills

Ausbildung

Biological/life sciences degree

Advanced degree desirable (PhD/PharmD/MSc)

Jobbeschreibung

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer‑driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long‑held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Opportunity

As part of our expanding European organization, we seek a strategic and hands‑on Associate Director, Regulatory Affairs, Europe who will provide regulatory leadership for designated programs at RevMed.

The candidate will be responsible for the preparation & 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 will be supporting engagement with health authorities including the EMA/MHRA/Swissmedic ensuring successful regulatory outcomes.

The role will report to the Director, Regulatory Affairs, Europe.

Primary Responsibilities

• Research regulatory requirements and identify relevant precendents to develop well‑vetted, actionable strategies for assigned programs.
• Independently plan, prepare and coordinate regulatory pathways for Marketing Authorisation Applications, and lifecycle management activities in the European Region.
• Support regional regulatory planning and oversee integrated filing plans, including timelines, deliverables, and critical path activities.
• Coordinate MAA submissions, including dossier readiness, and cross‑functional alignment.
• Serve, when applicable, as the primary regulatory liaison with European health authorities (e.g., EMA and EU/EEA national agencies), supporting the interactions and communications.
• Support 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 Regulatory Affairs leadership.
• Partner with regional and global regulatory leads to ensure alignment between global and regional regulatory strategies.
• Act as a strategic partner to cross‑functional teams, including R&D, 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.

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 8 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 7 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 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.