# Senior Director, Global Regulatory Strategy, Oncology

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

Canonical page: https://career.thegoodapps.co/jobs/22e4c3ca-0d88-4e8b-ac4d-dba07714d426

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

- Seniority: Director
- Salary: 167000 – 300700 USD per year

## Summary

Moderna is hiring a Director of Regulatory Strategy to lead approval pathways for messenger RNA therapies in oncology and other rare disease areas. This role suits an experienced regulatory affairs professional with deep FDA and international expertise who can navigate complex clinical programs from development through market authorization.

_Our summary, not Moderna's wording._

## Required

- BA/BS degree in scientific or engineering discipline
- 10+ years pharmaceutical industry experience
- 8+ years regulatory strategy experience
- Expert knowledge of FDA, EU, and ICH guidelines for oncology
- Strong experience with CTD format and regulatory filings
- Knowledge of regulatory procedures for drug development across US and EU markets
- Ability to manage multiple programs independently in fast-paced environment
- Excellent verbal and written communication skills

## Nice to have

- PharmD, Master's degree, or PhD
- Track record of securing product approvals and maintaining complex portfolios
- Experience leading regulatory authority meetings across drug development phases
- Regulatory knowledge across multiple therapeutic areas
- Delivery of at least one major regulatory application (NDA/BLA/MAA/JNDA)
- Experience developing and implementing competitive regulatory strategies

Apply on Moderna's site: https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx/job/Cambridge-Massachusetts/Director--Global-Regulatory-Strategy--Oncology_R19573-1