Manager, Regulatory Affairs CMC

Gilead Sciences

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

Posted 9/24/2026full-timeUnited StatesMid-LevelSenior💰 $133,195 - $189,640 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in CMC regulatory requirements and ICH guidelines, with a strong focus on lentiviral vector manufacturing processes and lifecycle management. Proven ability to support regulatory submissions and health authority interactions while fostering effective cross-functional collaboration.

Highest-signal resume keywords

CMC Regulatory RequirementsLentiviral Vector ManufacturingRegulatory SubmissionsHealth Authority InteractionsCross-Functional Collaboration

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

IND SubmissionCTA SubmissionBLA SubmissionMAA SubmissionRegulatory Impact AssessmentProcess ValidationControl Strategy DevelopmentViral Vector Product CharacterizationLifecycle ManagementAnalytical Characterization

Soft Skills

Strong Written CommunicationStrong Verbal CommunicationAttention to DetailOrganizational SkillsProactive Mindset

Industry Keywords

Cell TherapyGene TherapyATMP ProgramsComparabilityViral Vector Starting MaterialsAdventitious Agent ControlInspection ReadinessSupply Chain ManagementProcess ControlsCritical Quality Attributes

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, lentiviral vectors, and critical raw materials
Assist in executing global CMC regulatory strategies under senior staff guidance
Partner with process development, manufacturing, analytical testing, comparability, and supply continuity teams
Support health authority interactions, information-request responses, 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 operations
Contribute to inspection readiness activities and prepare supporting facility documentation
Maintain accurate regulatory records and documentation
Identify and escalate risks and contribute to mitigation strategies
Participate in continuous improvement and knowledge-sharing initiatives
Contribute to timely regulatory submissions, responses, assessments, and risk management for LVV manufacturing changes, facility transfers, process improvements, and capacity expansions
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
Degree in a scientific discipline preferred
Foundational knowledge of CMC regulatory requirements and ICH guidelines
Working knowledge of lentiviral vector manufacturing processes, process controls, critical quality attributes, 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 potential regulatory impact on LVV quality, safety, potency, and supply continuity
Experience with cell and gene therapy, CAR-T, or ATMP programs, including substantial experience with lentiviral vectors, 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, vector safety assessments, adventitious agent control, and viral vector product characterization preferred
Experience supporting internal or contract manufacturing organizations involved in LVV production and supply chain management preferred
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

Benefits

Comp & perks

Discretionary annual bonus eligibility
Discretionary stock-based long-term incentives eligibility may vary based on role
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