# Associate Director, Global Regulatory Science, CMC

Hiring organization: [Moderna](https://career.thegoodapps.co/organizations/moderna)

Canonical page: https://career.thegoodapps.co/jobs/e8d03bee-d8d4-40c5-a1bb-8d2d33cba85f

Listed on Moderna's own careers site. Applications go to them directly.

- Seniority: Senior

## Summary

Lead CMC regulatory strategy development and global submissions for Moderna's mRNA medicine portfolio, working across multiple programs to guide manufacturing and quality teams while representing the company to health authorities. This role suits experienced regulatory professionals with deep biologics expertise who want to shape innovative medicine development at a company-wide scale.

_Our summary, not Moderna's wording._

## Skills named

Manufacturing Processes

## Required

- BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field
- 10+ years pharmaceutical or biotech industry experience with manufacturing and/or analytical focus
- 8+ years biologics-focused regulatory CMC experience
- Strong knowledge of EU and rest-of-world regulations
- Strong knowledge of cGMP
- Strong experience with CTD format and content in regulatory filings
- Exceptional written and oral communication

## Nice to have

- MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field
- Multidisciplinary focus on vaccines, oncology, and/or rare diseases

Apply on Moderna's site: https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx/job/London---England/Associate-Director--Global-Regulatory-Science--CMC_R19319-1