Revolution MedicinesHiring

Associate Director, CMC Regulatory

  • Remote, United States
  • Full-time
  • Lead
  • Posted 12 days ago
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In one line

Regulatory lead for chemistry, manufacturing and controls on a pipeline of oral cancer drugs, steering filings from early trials through approval and beyond.

About the role

The team works on medicines aimed at cancers driven by RAS mutations. This job sets the CMC path for those compounds and keeps the quality sections of filings on track worldwide.

At a glance

Pay
Not stated in the posting
Remote scope
Remote, United States
Seniority
Lead
Employment
Full-time
Skills
CMC regulatory affairs, IND, IMPD/CTA, NDA, MAA, GMP
Posted
21 Oct 2026
Last checked
1 Nov 2026

What you will do

  • Set and carry out global CMC filing plans for trials, registrations and post-approval changes.
  • Write and keep current the quality parts of IND, IMPD/CTA, NDA and MAA dossiers, plus answers to agency questions.
  • Sit on project teams as the CMC regulatory voice and check that rules are met for trial and marketed products.
  • Work with internal regulatory staff, subject experts and CROs on country-specific needs and filing deadlines.
  • Advise on change controls, deviations and investigations across the product life cycle.
  • Help improve internal processes and SOPs as the portfolio goes global.

What they look for

  • A degree in pharmaceutical science, chemistry, chemical engineering or a similar field.
  • Ten or more years in drug development, with at least five in global CMC regulatory affairs.
  • Hands-on work on CMC submissions such as IND, IMPD/CTA, NDA and MAA across the US, EU, APAC and LATAM.
  • Good grasp of US and international GMP quality rules and how to apply them to projects and marketed products.
  • Experience with CMC development of small molecule new chemical entities.

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Questions about this job

Is this a remote job, and where can I work from?

Yes. The posting lists Associate Director, CMC Regulatory as a remote role for candidates in the United States.

What does this job pay?

No pay range is stated in the posting.

What experience is needed?

It is a lead role. The posting asks for: a degree in pharmaceutical science, chemistry, chemical engineering or a similar field; ten or more years in drug development, with at least five in global CMC regulatory affairs; hands-on work on CMC submissions such as IND, IMPD/CTA, NDA and MAA across the US, EU, APAC and LATAM. Skills it names include CMC regulatory affairs, IND, IMPD/CTA, NDA.

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