Revolution Medicines
Senior Director, CMC Regulatory
Revolution Medicines, Redwood City, California, United States, 94061
Global Cmc Regulatory Strategy Leader
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-time position is $236,000 to $295,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training. Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
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-time position is $236,000 to $295,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training. Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.