# Associate Director, CMC Regulatory Affairs, International

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

Canonical page: https://career.thegoodapps.co/jobs/a7655413-34f8-4255-95e5-a7cfadf6aca2

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

- Seniority: Senior

## Summary

This role leads CMC regulatory strategy and compliance activities for Moderna's global mRNA product portfolio, managing submissions to international health authorities across vaccines, oncology, and rare diseases. It suits experienced regulatory professionals with strong biologics CMC expertise and knowledge of EU and international pharmaceutical regulations.

_Our summary, not Moderna's wording._

## Skills named

Good Manufacturing Practice (GMP)

## Required

- Bachelor's degree in Pharmaceutics, Chemistry, Chemical Engineering, or related field
- 10+ years pharmaceutical/biotech industry experience with manufacturing and/or analytical focus
- 8+ years biologics-focused regulatory CMC experience
- Knowledge of EU and international (ROW) regulations
- Knowledge of cGMP
- Experience with CTD format and regulatory filings
- Strong written and oral communication

## Nice to have

- Master's degree in Pharmaceutics, Chemistry, Chemical Engineering, or 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--CMC-Regulatory-Affairs--International_R19267-1