Head of CMC Regulatory Affairs – Small Molecules
Gilead SciencesUnited States - California - Foster City · full time · Director
$302,005 – $390,830
Listed on Gilead Sciences’s own careers site. You apply with them directly — we never stand between you and the employer.
What this role is
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. The full posting is on their site.
What they ask for
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