Associate Director, Regulatory Operations

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys 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 Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Associate Director Regulatory Operations will serve as a key publishing lead within the Regulatory Operations function responsible for managing and executing regulatory submission activities to support the companys growing pipeline and portfolio. This individual will ensure timely accurate and compliant submissions to the FDA and other global Health Authorities while contributing to the effective management of regulatory information systems and processes that enable operational efficiency and scalability.

This role is an individual contributor with leadership responsibilities partnering cross-functionally with clinical quality CMC nonclinical and regulatory strategy teams to ensure seamless document management publishing and submission execution. The Associate Director also plays a key role in maintaining the integrity of regulatory information and ensuring compliance with global health authority requirements in a dynamic fast-paced environment.

Regulatory Publishing & Submission Management

• Oversee the planning preparation publishing submission and archiving of regulatory dossiers in eCTD format for multiple FDA applications and global submissions.

• Manage submission production and quality control (QC) processes ensuring compliance with global regulatory requirements and internal standards.

• Provide technical expertise in eCTD publishing tools and platforms (e.g. Veeva Vault RIM) to enable efficient and compliant submission execution.

• Proactively manage publishing timelines from request through archive anticipating potential issues escalating risks early and collaborating with cross-functional teams to adapt plans as needed.

Systems Tools & Process Optimization

• Support the implementation optimization and maintenance of regulatory systems tools and technologies to improve submission efficiency and scalability.

• Partner with cross-functional stakeholders to ensure regulatory systems and workflows are well-documented scalable and aligned with business needs.

• Drive the development and continuous improvement of SOPs templates style guides and document standards to support compliance and operational efficiency.

• Stay informed on emerging tools technologies and industry best practices identifying opportunities to enhance submission operations and supporting the evaluation and adoption of innovative solutions where appropriate.

Cross-Functional Leadership & Vendor Oversight

• Collaborate with internal stakeholders across clinical CMC quality nonclinical and regulatory strategy teams to coordinate the creation review and approval of regulatory submission documents.

• Manage relationships with publishing vendors and consultants ensuring appropriate resource allocation and adherence to quality and delivery expectations.

• Provide training and guidance to internal teams on publishing procedures tools and best practices to ensure submission readiness.

Strategic Contribution & Compliance

• Communicate complex regulatory and operational issues clearly providing solutions that balance compliance with the demands of growth and scale.

• Conduct gap analyses of regulatory operations policies procedures and SOPs driving initiatives to enhance departmental efficiency and compliance.

• Maintain current knowledge of regulatory requirements evolving eCTD guidance and the broader regulatory operations landscape providing interpretation and guidance to internal stakeholders.

Required Skills Experience and Education:

• Bachelors degree in a life science technical or related field with 8 years of Regulatory Operations and publishing experience in the biopharmaceutical industry; advanced degree preferred.

• Expert-level proficiency in Microsoft Word Adobe Acrobat Professional Toolbox and StartingPoint.

• Thorough understanding of eCTD publishing standards submission formatting transmission and archiving regulations and guidelines.

• Experience preparing and submitting regulatory dossiers to multiple global Health Authorities; oncology experience is a plus.

• Demonstrated ability to manage and prioritize multiple FDA applications and submissions with overlapping deadlines while maintaining accuracy and compliance.

• Ability to anticipate risks and proactively identify solutions to potential publishing and submission challenges.

• Strong organizational skills with high attention to detail and the ability to work independently in a dynamic fast-paced environment.

• Proven success collaborating with cross-functional teams and external vendors to deliver high-quality compliant submissions.

• Excellent interpersonal and communication (written and verbal) skills; able to work effectively across multiple groups maintaining professionalism diplomacy and a positive approach.

Preferred Skills:

• Some experience with people management such as mentoring training or overseeing vendors and consultants.

• Proficiency with Veeva Vault RIM or similar regulatory information management systems.

• Experience using Smartsheet or equivalent project management tools. #LI-Hybrid #LI-SH1