Senior Manager, Regulatory Affairs CMC

Gilead Sciences

. Support and drive operational and lifecycle management activities for Regulatory CMC submissions across global cell therapy / CAR-T clinical and commercial programs .

Posted 9/16/2026full-timeSanta Monica • California • United StatesSenior💰 $143,225 - $185,350 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CMC Regulatory Affairs, particularly for ATMPs and cell therapy products, with a strong focus on lifecycle management, regulatory submissions, and cross-functional collaboration. Proficient in interpreting regulatory guidance and applying it to complex manufacturing scenarios while ensuring compliance and risk management.

Highest-signal resume keywords

CMC Regulatory RequirementsRegulatory Submissions AuthoringCross-Functional CollaborationLifecycle Management ActivitiesGMP Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Regulatory SubmissionsINDsCTAsBLAsMAAsICH RequirementsRegulatory Guidance InterpretationChange ManagementRisk Mitigation StrategiesInspection Readiness

Soft Skills

Effective CommunicationOrganizational SkillsAttention to DetailSound JudgmentStakeholder Partnership

Industry Keywords

Cell TherapyATMPCAR-TBiotechnologyBiopharmaceuticalGlobal Regulatory FilingsManufacturing Change ControlsMulti-Site ManufacturingSite Expansion ActivitiesRegulatory Affairs

About the role

Key responsibilities & impact

Support and drive operational and lifecycle management activities for Regulatory CMC submissions across global cell therapy / CAR-T clinical and commercial programs
Prepare, coordinate, and critically review CMC regulatory submissions in accordance with ICH, regional, and internal requirements
Contribute to CMC content for INDs, CTAs, BLAs, MAAs, supplements, variations, amendments, and post-approval submissions
Support global CMC regulatory strategies aligned with program objectives, business timelines, and health authority expectations
Ensure harmonization and consistency of Module 3 content across applications, regions, and lifecycle activities
Identify CMC risk areas and recommend mitigation strategies and scenario planning
Serve as Regulatory CMC representative on cross-functional teams with Technical Operations, MSAT, Process & Analytical Development, Quality, Manufacturing, Supply Chain, and Clinical stakeholders
Support regulatory strategy for vector-related changes and comparability considerations
Provide regulatory input for manufacturing site expansion and registered-detail updates
Contribute to inspection readiness, regulatory responses, and inspection planning
Support health authority responses, briefing materials, and CMC agency meetings
Assess manufacturing change controls for global regulatory impact
Maintain accurate CMC registered details and associated documentation
Present project status, risks, and regulatory considerations in meetings and forums
Contribute to continuous improvement initiatives, templates, tools, policies, procedures, and knowledge sharing
May lead CMC RA sub-teams or special initiatives and coach less experienced colleagues

Requirements

What you’ll need

Bachelor's Degree and Eight Years' Experience OR Masters' Degree and Six Years' Experience OR PhD with 0+ Years' Experience
Strong understanding of CMC regulatory requirements for ATMPs / cell therapy products
Knowledge of ICH requirements and current global trends in CMC Regulatory Affairs
Experience authoring or coordinating CMC sections of regulatory submissions
Experience supporting lifecycle management activities
Ability to interpret regulatory guidance and apply it to product, process, and manufacturing scenarios
Strong cross-functional collaboration and stakeholder partnership skills
Effective written, verbal, and interpersonal communication skills
Strong organizational skills and attention to detail
Ability to manage multiple priorities with shifting timelines
Sound judgment and ability to propose practical, compliant, and risk-based solutions
Significant experience in Regulatory Affairs CMC within the biotechnology or biopharmaceutical industry
Experience supporting cell therapy / ATMP / CAR-T programs
Experience supporting global regulatory filings and lifecycle management for complex products
Familiarity with vector-related regulatory considerations, comparability strategies, and complex manufacturing changes is highly desirable
Experience with multi-site manufacturing strategies, site expansion activities, or global change management is preferred
GMP knowledge or experience is strongly preferred

Benefits

Comp & perks

Discretionary annual bonus eligibility
Discretionary stock-based long-term incentives eligibility
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