Senior Manager, Regulatory Affairs CMC

Gilead Sciences

. Lead or support integrated global CMC regulatory strategies for T-cell drug product and lentiviral vector programs .

Posted 9/29/2026full-timeSanta Monica • California • United StatesSenior💰 $143,225 - $185,350 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Regulatory CMC strategies for T-cell and lentiviral vector programs, with a strong focus on global submissions, health authority interactions, and compliance with GMP and ICH requirements. Capable of leading cross-functional teams and coaching colleagues while managing complex regulatory submissions and ensuring inspection readiness.

Highest-signal resume keywords

Regulatory Affairs CMC ExperienceT-Cell Drug Product ManufacturingLentiviral Vector ManufacturingGlobal Submissions and Health Authority InteractionsGMP and ICH Compliance

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Hard Skills

Regulatory CMC StrategyIND/CTA CMC PackagesQuality Attributes and SpecificationsProcess Performance QualificationChange Control AssessmentTechnical Writing for Regulatory SubmissionsAnalytical Method DevelopmentManufacturing Process ValidationComparability and Bridging StrategiesInspection Readiness

Soft Skills

LeadershipCoachingCommunicationProblem-SolvingDecision-Making

Industry Keywords

BiotechnologyBiopharmaceutical DevelopmentCell TherapyGene TherapyATMPsClinical DevelopmentMulti-Site ManufacturingTechnology TransferRegulatory CommitmentsHealth Authority Engagement

About the role

Key responsibilities & impact

Lead or support integrated global CMC regulatory strategies for T-cell drug product and lentiviral vector programs
Serve as Regulatory CMC representative on program and technical teams
Convert program decisions into regulatory requirements, submission plans, health authority engagement strategies, risks, mitigations, and decision points
Define phase-appropriate CMC content and evidence expectations
Provide regulatory guidance for autologous T-cell manufacturing processes and assess manufacturing process changes
Guide T-cell control strategy, including quality attributes, process parameters, in-process controls, specifications, potency, identity, purity, viability, safety testing, and comparability criteria
Support site additions, technology transfers, manufacturing network expansion, process performance qualification, comparability, validation, and post-approval change strategies
Provide regulatory guidance for lentiviral vector manufacture and assess LVV process and analytical changes
Guide LVV control strategy and develop regulatory approaches for LVV comparability and bridging
Define phase-appropriate IND/CTA CMC packages and prepare or review submissions, amendments, health authority questions, and regulatory meeting materials
Drive CMC readiness for pivotal studies and BLA/MAA submissions
Lead or support responses to information requests, deficiency letters, and health authority meeting questions
Assess post-approval changes and change controls
Support inspection readiness by aligning filings with site practices, validation status, manufacturing history, quality systems, and commitments
Author, coordinate, and critically review CMC sections for INDs, CTAs, BLAs, MAAs, supplements, variations, amendments, annual reports, renewals, and post-approval commitments
Maintain registered details, regulatory commitments, correspondence, assumptions, and decision history
Present status, risks, options, and recommendations to technical teams and leadership
Contribute to Regulatory CMC templates, playbooks, precedents, intelligence, and training
Coach less experienced colleagues and fulfill people-leader accountabilities

Requirements

What you’ll need

Bachelor’s degree and eight years’ experience, or Master’s degree and six years’ experience, or PhD
Degree in a scientific discipline or related field
Significant Regulatory Affairs CMC experience in biotechnology or biopharmaceutical development
Direct experience supporting cell therapy and/or viral vector programs
Hands-on experience with both autologous T-cell drug product manufacturing and LVV manufacturing strongly preferred
Experience across early clinical development and pivotal, registration, commercial, or post-approval programs
Experience with global submissions and health authority interactions
Experience with multi-site manufacturing networks, technology transfers, external manufacturers/testing laboratories, inspection readiness, and global change management
Strong working knowledge of GMP and relevant ICH and regional requirements for ATMPs/cell and gene therapy products
Strong understanding of global CMC regulatory expectations for cell and gene therapy products
Technical understanding of autologous T-cell unit operations, individualized manufacturing controls, chain of identity/custody, cryopreservation, product testing, comparability, and site/network changes
Technical understanding of LVV manufacturing, raw materials and plasmids, cell banks, viral safety, vector-specific analytical methods, potency, titer, purity, residuals, stability, and reference standards
Ability to connect LVV attributes and process changes to T-cell manufacturing performance and final drug product quality
Ability to evaluate development, characterization, validation, comparability, stability, and manufacturing data
Demonstrated ability to author and review high-quality CMC submissions and communicate complex issues clearly
Operates with considerable independence and sound judgment
Ability to manage parallel priorities across early- and late-stage programs
Ability to lead Regulatory CMC sub-teams or special initiatives and coach colleagues

Benefits

Comp & perks

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical insurance
Company-sponsored dental insurance
Company-sponsored vision insurance
Company-sponsored life insurance
Flexible working policy with two days of remote working and three days working onsite