Manager, Regulatory Affairs CMC

Gilead Sciences · Santa Monica, CA +3 more

RoleLantern checked

RegulatoryFull-time$133k–$172kCompany career page

The apply link worked recently (not employer-confirmed).

Role summary

Manager, Regulatory Affairs CMC at Kite (Gilead Sciences) leads chemistry, manufacturing, and controls regulatory submissions for autologous CAR T-cell therapies in clinical development and commercial expansion. The role manages global CMC lifecycle, regulatory strategy, and cross-functional collaboration across technical operations, quality, and manufacturing teams.

What they're looking for

Bachelor's degree and six years' experience, or Master's degree and four years' experience
Scientific degree preferred (Chemistry, Biochemistry, Biology, Chemical Engineering, or related field)
5+ years regulatory CMC and/or drug development experience with FDA-regulated products
Experience with biologics, cell therapy, or gene therapy products strongly preferred
Knowledge of global regulatory requirements (FDA, EMA, international agencies)
Strong written and verbal communication skills with ability to translate complex CMC topics
Experience supporting both clinical development and commercial lifecycle management

What you'll be doing

Lead operational and lifecycle management of regulatory CMC submissions (INDs, IMPDs, BLAs, MAAs, variations, amendments) for global CAR-T programs
Author, review, and coordinate Module 3 content ensuring global alignment across US, EU, and international health authorities
Develop and execute CMC regulatory strategies supporting process changes, raw material updates, analytical improvements, and shelf-life extensions
Serve as Regulatory CMC lead on assigned program and platform teams, applying advanced knowledge of autologous cell therapy requirements
Identify CMC regulatory risks, anticipate regulator questions, and develop mitigation plans through change control processes

Privacy & handoff

This role links to Gilead Sciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.

What RoleLantern checked

This role is listed from an approved source. RoleLantern checks that the application link is live and how recently the role appeared — the employer has not confirmed it directly on RoleLantern.

RoleLantern checked active

RoleLantern checkedPay range listed

Date posted1 day ago

Last source checkToday

Salary listedListed

Location clearClear

Something look off? Let us know and we may ask the employer to verify it.

See how you match this role

Upload your CV to see which of this role's requirements your background supports, where there may be gaps, and what needs clarification. Private by default — we never sell your CV.

See my match