Senior Director, CMC Regulatory

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 position is responsible for developing, leading, and executing global commercial CMC regulatory strategies to enable the marketing approval of RevMed’s pipeline compounds / products and post-approval activities.  The role will be leading preparation of CMC dossiers for regulatory submissions, interacting with global regulatory authorities, and providing strategic guidance to internal and cross-functional teams to ensure compliance with all applicable regulatory requirements.

Responsibilities:

• Develop and lead execution of effective global CMC regulatory strategies to support initial marketing approvals and lifecycle management of RevMed's product portfolio.

• Oversee the preparation and submission of high-quality CMC dossiers for global marketing authorization applications, including NDAs, MAAs, JNDAs, and post-approval. supplements/variations. Ensure timely and effective responses to Health Authority queries.

• Act as the CMC regulatory representative on cross-functional project teams, ensuring alignment with regulatory expectations and strategic program objectives.

• Assess the global regulatory implications of proposed CMC changes and provide proactive, risk-based guidance to optimize implementation and maintain compliance.

• Partner with corporate Regulatory Affairs, technical SMEs, and external CROs to identify and address region-specific CMC requirements for successful global regulatory submissions.

• Manage/lead interactions with Health Authorities as needed.

• Provide strategic leadership, mentorship, and technical guidance to junior team members to foster professional development and team performance.

• Contribute to continuous improvement initiatives to enhance regulatory excellence, streamline processes, and support the growth and operational effectiveness of the CMC Regulatory function.

• Monitor evolving global regulatory trends and requirements, deliver timely insights and strategic interpretations to internal stakeholders, and champion process innovations where appropriate.

Required Skills, Experience, and Education:

• Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related scientific discipline.

• Minimum of 18 years of experience in pharmaceutical / biotech drug development, including at least 8 years of hands-on global CMC regulatory affairs experience

• Deep expertise in CMC development for new chemical entities (NCEs) and small molecules, with proven ability to manage complex technical content.

• Extensive experience leading global CMC regulatory strategy and global marketing approval applications across the US, Europe, UK, and APAC regions.

• Strong knowledge of US and international GMP regulations, current industry practices, with a demonstrated ability to interpret and apply requirements across the product lifecycle.

• Proven track record of building and maintaining productive relationships with global Health Authorities, including direct interactions with the FDA and other regulatory bodies.

• Strong project and team leadership capabilities, with the ability to prioritize effectively, manage multiple complex programs, and foster cross-functional collaboration.

• Demonstrated experience in managing and developing high-performing teams, including mentoring, performance management, and talent development.

• Effective written and verbal communication skills and interpersonal skills.

• A collaborative, high-energy team player who thrives in a fast-paced, dynamic environment and embraces innovation and continuous improvement.

Preferred Skills:

• Advanced degree (MS or Ph.D) in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.

• Broader global regulatory experience, including regions such as Latin America (LATAM), is highly desirable.

• Additional CMC regulatory experience supporting clinical-stage development programs is preferred.

The base salary range for this full-