The Opportunity:

The Executive Director, Head of Quality, Europe is responsible for leading and overseeing all Quality functions across the European region, ensuring compliance with European regulatory requirements. This role provides strategic and operational leadership across GxP Quality (GMP, GDP, GCP as applicable). In addition, this role serves as the key Quality representative for Europe, partnering closely with Regulatory Affairs, Manufacturing, Supply Chain, Clinical Operations, and external partners to ensure a robust and inspection-ready quality system.

Key Responsibilities:

• Lead and develop the European Quality organization, ensuring alignment with global quality strategy and supporting the transition from clinical to commercial operations.

• Act as the primary Quality representative for Europe, providing leadership in regional and global governance forums and serving as the main interface with European regulatory authorities (e.g., EMA, national agencies).

• Ensure Quality oversight of MAH responsibilities, including lifecycle management, product complaints, recalls, and fulfillment of regulatory commitments in close collaboration with Regulatory Affairs.

• Establish, implement, and maintain an effective EU Quality Management System (QMS) in compliance with EU GMP, GDP, GCP (as applicable), and ICH guidelines.

• Participate in cross-functional review of Global SOPs, ensuring timely harmonization and effective implementation within the EMEA region.

• Oversee key quality system processes, including deviations, CAPAs, change control, risk management, product quality complaints, and document management.

• Monitor QMS performance through KPIs, risk indictors and management review process.

• Review quality agreements to ensure compliance with EU GMP, GDP and other regulatory requirements across the supply chain.

• Define and oversee the EU QP framework, ensuring compliant batch certification and appropriate governance of internal and/or contracted QPs.

• Ensure full compliance with EU GDP requirements, including oversight of distribution activities, wholesale authorizations, and Responsible Person (RP) functions within the EU supply network.

• Provide end-to-end Quality oversight of external partners (e.g., CMOs, 3PLs, distributors), including quality agreements, performance monitoring, and risk-based governance.

• Lead inspection readiness across Europe and manage regulatory inspections and internal/external audits, ensuring consistent positioning and effective interaction with authorities.

• Support regulatory submissions and lifecycle activities by ensuring quality oversight of relevant documentation and CMC components.

• Provide Quality leadership for new product introductions, technology transfers, and commercial launches in Europe, ensuring readiness of systems, processes, and partners.

• Collaborate cross-functionally with Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, and Global Supplier Quality to ensure integrated and compliant execution across the product lifecycle.

• Drive a strong, proactive quality culture across all European operations, promoting continuous improvement and accountability.

Required Skills, Experience and Education:

• Degree in Life Sciences, Pharmacy, Chemistry, or related field (PhD, PharmD, or MSc preferred).

• 20+ GxP Quality within the pharmaceutical industry.

• Track record of building and scaling Quality organizations.

• Track record of working in a GMP/GDP regulated environment.

• Deep knowledge of European regulatory requirements (EMA, EU GMP/GDP, ICH guidelines).

Preferred Skills:

• Biotech experience.

• Significant leadership experience, including managing regional or global teams.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

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The Opportunity:

The Associate Director, Regulatory Operations, Europe will play a key role in supporting the growing European Regulatory Affairs organization by leading the operational planning and execution of regulatory submissions across the region. This role partners closely with the European Regulatory Affairs team to operationalize regional regulatory strategies and ensure successful execution of regulatory submissions to health authorities across the EU, EEA, UK and Switzerland.

Working cross-functionally with regulatory strategy, clinical, CMC, nonclinical, and quality teams, the Associate Director will drive submission planning, manage regulatory documentation, and coordinate cross-functional teams to deliver high-quality submissions in accordance with global and regional regulatory operations processes and systems. While primarily focused on the European region, this role operates within Global Regulatory Operations and may support regulatory submissions in other regions as business needs evolve.

Primary Responsibilities:

• Serve as the primary Regulatory Operations partner supporting the European Regulatory Affairs team to execute regional regulatory strategies.

• Lead operational planning, preparation, publishing, and submission of regulatory dossiers to European health authorities including EMA, EU/EEA national authorities, MHRA, and Swissmedic.

• Lead regulatory submission planning and operational execution for major regulatory applications including Marketing Authorisation Applications (MAA), ensuring effective coordination of submission timelines, dossier assembly, publishing, and submission readiness.

• Develop and manage detailed regulatory submission timelines, proactively driving cross-functional teams to ensure timely preparation, review, and delivery of submission components.

• Coordinate cross-functional activities required for regulatory submissions, including document preparation, review cycles, and final submission readiness.

• Publish and perform quality control of regulatory submissions in eCTD format using DocuBridge, ensuring compliance with applicable regulatory technical requirements.

• Manage regulatory submission content and metadata within Veeva Vault RIM, ensuring accuracy and completeness of regulatory information and documentation.

• Support preparation and coordination of key regulatory deliverables including Clinical Trial Applications (CTA), scientific advice packages, pediatric plans, and lifecycle management submissions.

• Provide operational guidance to cross-functional teams regarding submission requirements, document standards, and regulatory timelines.

• Partner with Global Regulatory Operations to ensure alignment of regional submission processes, systems, and regulatory documentation standards.

• Manage external publishing vendors and consultants supporting regulatory submission activities.

• Provide regulatory operations support for global submissions as needed, collaborating with Global Regulatory Operations colleagues across regions.

• Manage regulatory procedures via EMA IRIS platform, including scientific advice, orphan designation, and other applicable EMA interactions.

• Ensure accuracy, completeness, and consistency of structured regulatory data and metadata across Veeva Vault RIM and European health authority systems (e.g., CTIS, IRIS, eSubmission Gateway).

• Coordinate submission activities across multiple European submission channels and platforms, ensuring alignment of dossier content and data across eCTD and portal-based submissions.

• Lead operational support for EU regulatory lifecycle activities, including variations, renewals, and other post-approval submissions, ensuring compliance with EU procedural requirements.

Required Skills, Experience and Education:

• Bachelor’s degree in life sciences or related discipline.

• 8+ years of experience in regulatory operations, regulatory affairs, or regulatory submission management within the biotechnology or pharmaceutical industry.

• Demonstrated experience preparing and publishing eCTD submissions to global health authorities.

• Strong understanding of European regulatory submission requirements and procedures.

• Hands-on experience using Veeva Vault RIM for regulatory information management.

• Hands-on experience using DocuBridge for regulatory publishing.

• Demonstrated ability to lead regulatory submission timelines and coordinate cross-functional submission deliverables.

• Strong understanding of regulatory document management, publishing standards, and regulatory submission lifecycle processes.

• Proven ability to manage multiple complex regulatory submissions simultaneously while maintaining high quality and compliance.

• Strong organizational, communication, and stakeholder management skills.

• Familiarity with EMA IRIS platform and associated regulatory procedures (e.g., scientific advice, orphan designation).

• Experience managing regulatory data, metadata, and submission tracking across multiple health authority systems and platforms.

Preferred Skills:

• Experience supporting regulatory submissions to European health authorities including EMA, MHRA, Swissmedic, or EU national competent authorities.

• Experience supporting Marketing Authorisation Applications (MAA) or other major marketing applications.

• Experience working in global regulatory teams supporting both regional and global regulatory submissions.

• Oncology or rare disease regulatory experience is considered an advantage.

• Experience managing regulatory publishing vendors or external regulatory consultants.

• Experience working within a growing or evolving regulatory organization.

• Experience navigating EU regulatory procedures (centralised, decentralised, or mutual recognition).

• Familiarity with evolving EU regulatory data standards (e.g., SPOR/IDMP) is a plus.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Hybrid #LI-LO1