# Global Regulatory CMC Lead

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

Canonical page: https://career.thegoodapps.co/jobs/62f4c69d-03ad-42ef-9155-735c532b60ec

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

- Employment type: full time
- Seniority: Senior
- Salary: 142500 – 256500 USD per year

## Summary

This role manages regulatory chemistry, manufacturing, and controls (CMC) strategy and submissions for pharmaceutical products at Moderna, guiding cross-functional teams through clinical and commercial approval processes. It suits experienced pharmaceutical scientists and engineers ready to lead regulatory strategy work for biologics in a matrix organization.

_Our summary, not Moderna's wording._

## Required

- BS, MS, or PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field
- 8+ years in pharmaceutical or biotech industry with manufacturing and/or analytical focus
- 5+ years in biologics-focused regulatory CMC
- Knowledge of global CMC regulations and CTD format
- Experience with regulatory procedures for drug development, registration, line extensions, and license maintenance
- Ability to collaborate cross-functionally in a matrix environment
- Independent work capability
- Strong written and oral communication

Apply on Moderna's site: https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx/job/Norwood-Massachusetts/Associate-Director--Global-Regulatory-CMC_R19258-2