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 9/28/2026full-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, compliance with GMP and ICH standards, and the ability to lead cross-functional teams in complex regulatory environments.

Highest-signal resume keywords

Regulatory Affairs CMC ExperienceCell Therapy Program SupportAutologous T-Cell ManufacturingGlobal Submissions and Health Authority InteractionsGMP and ICH Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory CMC Strategy DevelopmentIND/CTA CMC Package PreparationAnalytical Method ValidationProcess ValidationComparability AssessmentManufacturing Change ManagementTechnical Writing for CMC SubmissionsInspection ReadinessCell and Gene Therapy KnowledgeViral Vector Manufacturing

Soft Skills

Leadership and CoachingCross-Functional CollaborationCritical EvaluationCommunication of Complex IssuesIndependent Operation

Industry Keywords

BiotechnologyBiopharmaceutical DevelopmentATMPsChain of IdentityChain of CustodyCryopreservationProduct TestingStability StudiesManufacturing NetworksRegulatory Compliance

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
Translate program decisions into regulatory requirements, submission plans, health authority strategies, risks, mitigations, and decision points
Provide regulatory guidance for autologous T-cell manufacturing across production, testing, storage, shipping, and chain-of-identity/chain-of-custody controls
Assess T-cell and LVV process, analytical, equipment, supplier, site, scale, formulation, and manufacturing changes
Guide T-cell and LVV control strategies, comparability, bridging, validation, stability, potency, safety, and reference standards
Define phase-appropriate IND/CTA CMC packages and support early-stage development
Prepare and review CMC content for submissions, amendments, scientific advice, and regulatory meetings
Drive CMC readiness for pivotal studies, BLA/MAA submissions, commercial readiness, and post-approval lifecycle activities
Author, coordinate, and review CMC sections for INDs, CTAs, BLAs, MAAs, supplements, variations, amendments, annual reports, renewals, and commitments
Support inspection readiness, site additions, technology transfers, manufacturing network expansion, and post-approval changes
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 lead selected Regulatory CMC sub-teams or special initiatives
Create inclusion, develop talent, and empower teams as a people leader

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 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 comparability, specifications, analytical method qualification/validation, process validation, stability, and manufacturing site changes
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 critically evaluate development, characterization, validation, comparability, stability, and manufacturing data
Demonstrated ability to author and review high-quality CMC submissions and communicate complex issues clearly
Ability to operate independently, manage parallel priorities, build cross-functional alignment, lead 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