Senior Director, Regulatory Affairs CMC

Gilead Sciences

Senior Director leading global CMC regulatory strategy and major submissions for CAR T-cell therapies. Collaborating with cross-functional teams and representing the company to regulatory authorities.

Posted 5/29/2026full-timeSanta Monica • California • 🇺🇸 United StatesSenior💰 $221,000 - $286,000 per yearWebsite

About the role

Key responsibilities & impact

Define and lead global CMC regulatory strategy for CAR‑T programs across early and late clinical development and post‑approval lifecycle management
Anticipate evolving global expectations for ATMPs/CAR‑T and proactively assess regulatory risks, opportunities, and mitigation strategies
Represent Regulatory CMC as a senior leader on cross‑functional governance and core teams
Provide executive oversight and critical review of Module 3 / Quality content for clinical and commercial applications
Ensure end‑to‑end consistency, scientific rigor, and regulatory defensibility of CMC dossiers, including in‑context review of compiled applications and health‑authority responses (e.g., RTQs, IRs)
Serve as a senior CMC subject‑matter expert for health authority interactions, including briefing documents and participation in agency meetings
Lead global CMC regulatory assessments for manufacturing and control changes, including process evolution, site transfers, comparability strategies, analytical changes, and shelf‑life updates
Drive lifecycle strategies that balance regulatory compliance, technical feasibility, supply continuity, and business objectives
Oversee complex global LCM planning, including sequencing, regional differences, and submission pathways
Provide strategic regulatory guidance to technical teams throughout product development, scale‑up, validation, and commercialization
Partner closely with Manufacturing, MSAT, Quality, and external CDMOs to ensure regulatory‑compliant execution
Review and provide oversight of CMC components supporting labeling, product information, and related regulatory documents
Lead, develop, and mentor a team of Regulatory CMC leaders and/or provide strong matrix leadership across programs
Set priorities and oversee resources, and timelines for a complex portfolio of submissions and lifecycle activities
Contribute to the advancement of Regulatory CMC capabilities, processes, and best practices globally

Requirements

What you’ll need

14 years of biopharmaceutical industry experience, including extensive Regulatory CMC leadership with a bachelor's degree or 12 years with a master's degree
Advanced degree preferred (PhD, PharmD, MS, or equivalent) in a scientific discipline
Deep experience with cell therapy and/or gene therapy products; CAR‑T experience strongly preferred
Demonstrated success leading global CMC strategies and major submissions (e.g., late‑stage clinical, BLA/MAA, post‑approval supplements)
Strong knowledge of ICH guidelines, ATMP regulations, and global CMC expectations (FDA, EMA, and key international markets)

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 strategyCMC leadershipclinical developmentpost-approval lifecycle managementregulatory compliancequality content reviewregulatory assessmentslifecycle management planningproduct developmentcell therapy

Soft Skills

leadershipstrategic guidancementoringcross-functional collaborationoversightresource managementcommunicationproblem-solvingprioritizationteam development

Certifications

PhDPharmDMS