# Head of CMC Regulatory Affairs – Small Molecules

Hiring organization: [Gilead Sciences](https://career.thegoodapps.co/organizations/gilead-sciences)

Canonical page: https://career.thegoodapps.co/jobs/42346a03-4592-421c-8470-134775bf191b

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

- Employment type: full time
- Seniority: Director
- Location: United States - California - Foster City
- Salary: 302005 – 390830 USD per year

## Summary

This is a senior regulatory leadership role overseeing chemistry, manufacturing, and controls strategy for small-molecule drug programs at a major pharmaceutical company. The position suits someone with deep expertise in CMC regulatory affairs who can drive global approval strategies and lead cross-functional teams through complex product lifecycles.

_Our summary, not Gilead Sciences's wording._

## Required

- 16+ years of small molecule CMC regulatory affairs experience (or 14+ years with advanced degree)
- Leadership experience with NDA/BLA submissions and global health authority interactions
- Demonstrated success leading complex cross-functional teams
- Strategic acumen and communication skills
- Track record in CMC regulatory innovation and strategy development

## Nice to have

- Experience with international regulatory forums (ICH, PhRMA, ISPE, IQ, Bios)
- Experience influencing in matrixed organizations
- Background in leading organizational and cultural development

Apply on Gilead Sciences's site: https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Head-of-CMC-Regulatory-Affairs---Small-Molecules_R0051842