Revolution Medicines
Associate Director, CMC Regulatory
Revolution Medicines, Redwood City, California, United States, 94061
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 Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
This position is responsible for developing and implementing CMC regulatory strategies. The role involves coordinating and preparing CMC sections of regulatory submissions to support the clinical development and eventual marketing approval of RevMed’s pipeline compounds/products.
Responsibilities:
Develop, lead, and implement global CMC regulatory strategies to support the clinical development through registration and post-marketing activities.
Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs.
Serve as the CMC regulatory representative on project teams and provide CMC regulatory support for the clinical development of the investigational product(s) and ensure applicable regulatory requirements are appropriately met.
Collaborate with corporate regulatory team, CMC SMEs and/or CROs to identify regional/country-specific CMC requirements to support global applications, and to drive the CMC submission timelines in order to meet business objectives.
Provide regulatory assessment and guidance on CMC related change controls, deviations, and investigations throughout product life cycle.
Lead and/or contribute to internal process improvements,
SOP development , and organizational initiatives to support globalization of RevMed’s products.
Maintain knowledge of global competitive landscape, regulatory environment, regulations and CMC guidance, providing interpretation to internal stakeholders.
Required Skills, Experience, and Education: BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.
10+ years of pharmaceutical / biotech drug development experience with 5 + years of experience of global CMC regulatory affairs.
Experience in leading CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM).
Solid knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.
Demonstrated experience in effective collaboration with internal and external stakeholders.
Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment.
Effective written and verbal communication skills and excellent interpersonal skills.
Preferred Skills: Advanced degree (MSc or PhD degree) in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable.
Working experience and content knowledge in CMC development of NCEs / small molecules or equivalent.
Self-driven, proactive, and able to operate independently while fostering collaboration across departments.
Ability and desire to coach and mentor junior regulatory CMC RA staff.
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Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and preparation of responses to queries from HAs.
Serve as the CMC regulatory representative on project teams and provide CMC regulatory support for the clinical development of the investigational product(s) and ensure applicable regulatory requirements are appropriately met.
Collaborate with corporate regulatory team, CMC SMEs and/or CROs to identify regional/country-specific CMC requirements to support global applications, and to drive the CMC submission timelines in order to meet business objectives.
Provide regulatory assessment and guidance on CMC related change controls, deviations, and investigations throughout product life cycle.
Lead and/or contribute to internal process improvements,
SOP development , and organizational initiatives to support globalization of RevMed’s products.
Maintain knowledge of global competitive landscape, regulatory environment, regulations and CMC guidance, providing interpretation to internal stakeholders.
Required Skills, Experience, and Education: BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.
10+ years of pharmaceutical / biotech drug development experience with 5 + years of experience of global CMC regulatory affairs.
Experience in leading CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM).
Solid knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.
Demonstrated experience in effective collaboration with internal and external stakeholders.
Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment.
Effective written and verbal communication skills and excellent interpersonal skills.
Preferred Skills: Advanced degree (MSc or PhD degree) in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field is desirable.
Working experience and content knowledge in CMC development of NCEs / small molecules or equivalent.
Self-driven, proactive, and able to operate independently while fostering collaboration across departments.
Ability and desire to coach and mentor junior regulatory CMC RA staff.
#LI-Hybrid #LI-CT1
#J-18808-Ljbffr