Revolution Medicines
Senior Manager, CMC Regulatory
Revolution Medicines, San Francisco, California, United States, 94199
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Senior Manager, CMC Regulatory
role at
Revolution Medicines .
Want to apply Read all the information about this position below, then hit the apply button. 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 includes RAS(ON) Inhibitors and RAS Companion Inhibitors, aimed at treating cancers with mutations in the RAS pathway. As a team member, you will work alongside outstanding scientists committed to patients with RAS-related cancers. The Opportunity: This role involves developing and executing global CMC regulatory strategies, coordinating activities to support clinical development and marketing approval of pipeline compounds. The ideal candidate should have a strong understanding of regulatory requirements and guide CMC teams through drug development. Responsibilities:
Manage CMC regulatory activities for global trials, ensuring compliance with FDA, EMA, APAC, and other regional regulations. Support the preparation of regulatory submission documents such as IND, IMPD/CTA, NDA, MAA, and amendments, including responses to health authority queries. Assess changes to clinical trial materials or processes and prepare necessary regulatory documents. Identify regulatory risks, manage timelines, and ensure timely submission of high-quality dossiers. Provide updates to senior management on regulatory activities and progress. Communicate regulatory strategies, risks, and issues proactively to project teams and stakeholders. Represent the department in cross-functional teams. Required Experience, Skills, and Education:
BA/BS in Pharmaceutical Science, Chemistry, Chemical Engineering, or related field. 7+ years in pharmaceutical/biotech drug development, with 3+ years in CMC regulatory roles. Experience leading global CMC submissions (IND, NDA, MAA, etc.). Strong knowledge of GMP regulations and industry practices. Effective collaboration and communication skills. Ability to manage multiple projects in a dynamic environment. Preferred Skills:
Advanced degree in relevant scientific fields. Experience managing CMC submissions across US, EU, APAC, LATAM. Team-oriented, adaptable, results-driven, strategic mindset. The salary range is $158,000 to $198,000, based in Redwood City, CA, with adjustments for location and experience. Compensation includes salary, equity, benefits, and development opportunities. Revolution Medicines is an equal opportunity employer committed to diversity and privacy protection. For more information, contact privacy@revmed.com. Additional Details:
Seniority level: Mid-Senior level Employment type: Full-time Job function: Legal
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Senior Manager, CMC Regulatory
role at
Revolution Medicines .
Want to apply Read all the information about this position below, then hit the apply button. 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 includes RAS(ON) Inhibitors and RAS Companion Inhibitors, aimed at treating cancers with mutations in the RAS pathway. As a team member, you will work alongside outstanding scientists committed to patients with RAS-related cancers. The Opportunity: This role involves developing and executing global CMC regulatory strategies, coordinating activities to support clinical development and marketing approval of pipeline compounds. The ideal candidate should have a strong understanding of regulatory requirements and guide CMC teams through drug development. Responsibilities:
Manage CMC regulatory activities for global trials, ensuring compliance with FDA, EMA, APAC, and other regional regulations. Support the preparation of regulatory submission documents such as IND, IMPD/CTA, NDA, MAA, and amendments, including responses to health authority queries. Assess changes to clinical trial materials or processes and prepare necessary regulatory documents. Identify regulatory risks, manage timelines, and ensure timely submission of high-quality dossiers. Provide updates to senior management on regulatory activities and progress. Communicate regulatory strategies, risks, and issues proactively to project teams and stakeholders. Represent the department in cross-functional teams. Required Experience, Skills, and Education:
BA/BS in Pharmaceutical Science, Chemistry, Chemical Engineering, or related field. 7+ years in pharmaceutical/biotech drug development, with 3+ years in CMC regulatory roles. Experience leading global CMC submissions (IND, NDA, MAA, etc.). Strong knowledge of GMP regulations and industry practices. Effective collaboration and communication skills. Ability to manage multiple projects in a dynamic environment. Preferred Skills:
Advanced degree in relevant scientific fields. Experience managing CMC submissions across US, EU, APAC, LATAM. Team-oriented, adaptable, results-driven, strategic mindset. The salary range is $158,000 to $198,000, based in Redwood City, CA, with adjustments for location and experience. Compensation includes salary, equity, benefits, and development opportunities. Revolution Medicines is an equal opportunity employer committed to diversity and privacy protection. For more information, contact privacy@revmed.com. Additional Details:
Seniority level: Mid-Senior level Employment type: Full-time Job function: Legal
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