Manager, Regulatory Affairs – CMC

Gilead Sciences

Manager, Global Regulatory CMC for CAR T-cell therapy at Kite supporting regulatory submissions and CMC management. Ensuring compliance and coordination with global regulatory standards across therapeutic programs.

Posted 5/29/2026full-timeSanta Monica • California • 🇺🇸 United StatesMid-LevelSenior💰 $133,195 - $172,370 per yearWebsite

About the role

Key responsibilities & impact

Lead all operational and lifecycle management aspects of Regulatory CMC submissions (e.g., INDs, IMPDs, BLAs, MAAs, variations, amendments) supporting global clinical and commercial CAR‑T programs
Serve as the Regulatory CMC lead on assigned program and/or platform teams, applying advanced knowledge of global CMC regulatory requirements for autologous cell therapies
Author, review, and coordinate Module 3 (M3) content, ensuring global alignment and harmonization across regions (US, EU, and other international health authorities)
Develop and execute CMC regulatory strategies that align with overarching regulatory and business strategies, including support for global site additions, process changes, raw material changes, analytical updates, and shelf‑life extensions
Proactively identify CMC regulatory risks and lead scenario planning, including anticipation of regulator questions and development of mitigation and contingency plans
Assess and provide regulatory impact evaluations for CMC changes through formal change control processes, ensuring appropriate global regulatory strategies are defined and executed
Support interactions with global health authorities by contributing to briefing packages, written responses, and regulatory meeting preparations specific to CMC topics
Collaborate cross‑functionally to ensure CMC deliverables meet regulatory requirements, quality standards, and program timelines
Support continuous improvement and best‑practice sharing for Regulatory CMC processes in a rapidly growing, dynamic environment

Requirements

What you’ll need

Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biochemistry, Biology, Chemical Engineering, or related field) with 6 years of relevant Regulatory CMC and/or drug development experience, including direct experience with FDA-regulated products or a master's degree in related scientific discipline and 4 years of relevant experience as listed above.
Experience supporting biologics and/or cell or gene therapy products is strongly preferred
Experience with autologous CAR‑T cell therapy or advanced therapy medicinal products (ATMPs)
Working knowledge of global regulatory requirements (FDA, EMA, and other international agencies)
Experience supporting both clinical development and commercial lifecycle management

Benefits

Comp & perks

company-sponsored medical, dental, vision, and life insurance plans.
discretionary annual bonus
discretionary stock-based long-term incentives (eligibility may vary based on role)
paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Regulatory CMC submissionsINDsIMPDsBLAsMAAsModule 3 (M3) contentCMC regulatory strategieschange control processesregulatory impact evaluationsbiologics

Soft Skills

leadershipcollaborationcommunicationproblem-solvingstrategic planningrisk assessmentcontinuous improvementcross-functional teamworkorganizational skillsadaptability