Manager, Regulatory Affairs CMC

Gilead Sciences

. Support preparation and submission of CMC regulatory filings, including INDs, CTAs, BLAs, MAAs, supplements, and variations .

Posted 9/18/2026full-timePhiladelphia • California • United StatesMid-LevelSenior💰 $133,195 - $172,370 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CMC regulatory requirements and global regulatory strategies for cell and gene therapy products, with a strong focus on lentiviral vector manufacturing and lifecycle management. Proven ability to manage regulatory submissions, health authority interactions, and cross-functional collaboration while ensuring compliance and inspection readiness.

Highest-signal resume keywords

CMC Regulatory FilingsLentiviral Vector ManufacturingRegulatory SubmissionsCross-Functional CollaborationAttention to Detail

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Regulatory RequirementsINDsCTAsBLAsMAAsModule 3 Content DevelopmentProcess ValidationControl Strategy DevelopmentViral Vector ComparabilityAnalytical Characterization

Soft Skills

Strong Written CommunicationStrong Verbal CommunicationOrganizational SkillsAbility to Manage Multiple PrioritiesEffective Collaboration

Industry Keywords

Cell TherapyGene TherapyATMP ProgramsRegulatory ExpectationsQuality AttributesLifecycle ManagementInspection ReadinessRisk Mitigation StrategiesHealth Authority InteractionsEmerging Guidance

About the role

Key responsibilities & impact

Support preparation and submission of CMC regulatory filings, including INDs, CTAs, BLAs, MAAs, supplements, and variations
Develop Module 3 (CMC) content aligned with global regulatory requirements for cell therapy products and associated LVV and critical raw materials
Assist with execution of global CMC regulatory strategies under guidance of senior staff
Partner with process development, manufacturing, analytical testing, comparability, and supply continuity teams to support regulatory deliverables
Support health authority interactions, including responses to information requests and meeting materials
Assess change controls for regulatory impact and support lifecycle management activities
Support manufacturing changes, comparability, and site updates for cell therapy and LVV manufacturing operations
Contribute to inspection readiness activities and prepare supporting documentation
Maintain accurate regulatory records and documentation
Identify and escalate risks and contribute to mitigation strategies
Participate in continuous improvement and knowledge-sharing activities
Create inclusion, develop talent, and empower teams as a people leader

Requirements

What you’ll need

Bachelor’s degree with six years' experience OR Master’s degree with four years' experience
Foundational knowledge of CMC regulatory requirements and ICH guidelines
Strong written and verbal communication skills
Attention to detail and strong organizational skills
Ability to manage multiple priorities in a fast-paced environment
Effective cross-functional collaboration
Working knowledge of lentiviral vector manufacturing processes, process controls, critical quality attributes (CQAs), and analytical characterization approaches
Understanding of regulatory expectations for viral vector comparability, process validation, control strategy development, and post-approval lifecycle management
Knowledge of global regulatory requirements and emerging guidance applicable to cell and gene therapy products, including viral vector starting materials
Ability to assess manufacturing changes and interpret their potential regulatory impact on LVV quality, safety, potency, and supply continuity
Degree in a scientific discipline preferred
Experience with cell and gene therapy / CAR-T / ATMP programs, including substantial experience with lentiviral vectors (LVV), viral vector manufacturing, characterization, control strategies, and lifecycle management preferred
Experience supporting regulatory submissions and health authority interactions preferred
Knowledge of regulatory expectations for replication-competent lentivirus (RCL), vector safety assessments, adventitious agent control, and viral vector product characterization preferred
Experience supporting internal or contract manufacturing organizations (CMOs) involved in LVV production and supply chain management preferred

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