Associate Director, Regulatory Affairs, Europe

Revolution Medicines, Inc.; Basel; Hybrid; CHF 150.000 - 230.000; Vollzeit

Zusammenfassung

Revolution Medicines is seeking an Associate Director, Regulatory Affairs, Europe to lead regulatory strategy and submissions across EU/EEA, UK and Switzerland for oncology programs. You will represent RA on cross-functional teams and interact with EMA/MHRA/Swissmedic to secure timely approvals.

The role requires extensive experience in European regulatory frameworks, strategic problem-solving with health agencies, and strong leadership in fast-paced environments.

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 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.

Aufgaben

• Research regulatory requirements and identify precedents to develop actionable strategies for assigned programs.
• Plan, prepare and coordinate regulatory pathways for Marketing Authorisation Applications and lifecycle management in Europe.
• Oversee integrated filing plans, timelines, deliverables and critical path activities.
• Coordinate MAA submissions, dossier readiness, and cross-functional alignment.
• Act as regulatory liaison with European health authorities (EMA, EU/EEA agencies).
• Prepare and review key regulatory submissions, including Scientific Advice, Paediatric Plans, and Orphan Designations.
• Identify and mitigate regulatory risks; communicate progress to leadership.
• Align global and regional regulatory strategies with regional leads.
• Partner with R&D, Medical Affairs, Safety, Market Access, and Commercial teams.
• Ensure compliance with European regulatory, pharmacovigilance, and governance requirements.
• Monitor evolving European requirements and communicate impact across functions.
• Oversee external vendors and CROs for timely, high-quality submissions and approvals.

Kenntnisse

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Stakeholder management

Project management

Communication skills

Ausbildung

Biological or life sciences degree

Advanced degree (PhD/PharmD/MSc) desirable

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.

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