Associate Director, CMC Regulatory

Revolution Medicines

1d•$177,000 - $221,000

About The Position

Revolution Medicines seeks a strategic and hands-on Associate Director, CMC Regulatory to execute CMC regulatory strategies supporting clinical development, marketing authorizations, and lifecycle management of pipeline compounds and products. The role coordinates and prepares CMC sections of regulatory submissions for global clinical trials, market applications, and post-approval changes. The successful candidate will understand global regulatory requirements across development phases and provide regulatory guidance to CMC teams.

Requirements

BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related field.
At least 10 years of pharmaceutical or biotech drug development experience, including at least 5 years in global CMC regulatory affairs.
Experience with global CMC regulatory submissions, including IND, IMPD/CTA, NDA, and MAA, across the US, EU, APAC, and LATAM.
Solid knowledge of US and international GMP quality regulations and current industry practices, with experience interpreting and applying them to development projects and marketed-product regulatory issues.
Working experience and content knowledge in CMC development of new chemical entities (small molecules) or equivalent.
Demonstrated effective collaboration with internal and external stakeholders.
Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment.
Ability to work effectively in a fast-paced, matrixed, global environment.
Effective written and verbal communication skills and excellent interpersonal skills.

Nice To Haves

Advanced degree (MSc or PhD) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related field.
Experience in an accelerated development program.
Self-driven and proactive, able to operate independently while fostering collaboration across departments.

Responsibilities

Develop, lead, and implement global CMC regulatory strategies for clinical development, registration, and post-marketing activities.
Lead preparation and maintenance of CMC and quality sections of regulatory submissions, including IND, IMPD/CTA, NDA, MAA, and amendments, and prepare responses to Health Authority queries.
Represent CMC regulatory on project teams, support development of investigational and marketed products, and ensure applicable regulatory requirements are met.
Work with the corporate regulatory team, CMC subject-matter experts, and CROs to identify regional and country-specific CMC requirements and drive submission timelines.
Assess and provide regulatory guidance on CMC-related change controls, deviations, and investigations throughout the product lifecycle.
Lead or contribute to process improvements, SOP development, and organizational initiatives supporting globalization of products.
Maintain knowledge of the global competitive landscape, regulatory environment, regulations, and CMC guidance, and interpret these for internal stakeholders.