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, particularly in lentiviral vector manufacturing. Proficient in managing regulatory submissions, health authority interactions, and lifecycle management activities while fostering effective cross-functional collaboration.

Highest-signal resume keywords

CMC Regulatory FilingsLentiviral Vector ManufacturingRegulatory SubmissionsHealth Authority InteractionsProcess Validation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Bachelor’s DegreeMaster’s DegreeRegulatory Requirements KnowledgeAnalytical CharacterizationChange Control AssessmentQuality Attributes UnderstandingLifecycle ManagementViral Vector ComparabilityControl Strategy DevelopmentRegulatory Documentation

Soft Skills

Strong Written CommunicationStrong Verbal CommunicationAttention to DetailOrganizational SkillsCross-Functional Collaboration

Industry Keywords

Cell TherapyGene TherapyATMP ProgramsViral Vector Safety AssessmentsAdventitious Agent ControlRegulatory ExpectationsProcess ControlsManufacturing ChangesInspection ReadinessSupply Chain Management

About the role

Key responsibilities & impact

Support preparation and submission of CMC regulatory filings, including INDs, CTAs, BLAs, MAAs, supplements, and variations
Contribute to Module 3 (CMC) content development for cell therapy products and associated LVV and critical raw materials
Assist in execution of global CMC regulatory strategies for cell therapy products and lentiviral vector manufacturing platforms
Partner with Process Design, MSAT, Quality, Manufacturing, and Supply Chain teams on 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 related to LVV manufacturing, supply, compliance, and health authority commitments
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
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
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
Proactive and solution-oriented mindset
Degree in a scientific discipline
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
Experience supporting regulatory submissions and health authority interactions
Knowledge of regulatory expectations for replication-competent lentivirus (RCL), vector safety assessments, adventitious agent control, and viral vector product characterization
Experience supporting internal or contract manufacturing organizations (CMOs) involved in LVV production and supply chain management

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