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Manager, Regulatory Affairs CMC
Gilead Sciences. Support preparation and submission of CMC regulatory filings, including INDs, CTAs, BLAs, MAAs, supplements, and variations .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in CMC regulatory requirements and strategies for cell therapy and lentiviral vector manufacturing, with a strong focus on regulatory submissions, compliance, and cross-functional collaboration. Possesses foundational knowledge of ICH guidelines and the ability to assess regulatory impacts on product quality and safety.
Highest-signal resume keywords
CMC Regulatory FilingsLentiviral Vector ManufacturingRegulatory Strategy DevelopmentHealth Authority InteractionsCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
CMC Regulatory RequirementsINDsCTAsBLAsMAAsRegulatory ComplianceProcess ValidationAnalytical CharacterizationChange Control AssessmentRisk Management
Soft Skills
Strong Written CommunicationStrong Verbal CommunicationAttention to DetailOrganizational SkillsProactive Mindset
Industry Keywords
Cell TherapyGene TherapyViral VectorCritical Quality AttributesLifecycle ManagementRegulatory ExpectationsComparabilityProcess ControlsAdventitious Agent ControlReplication-Competent Lentivirus
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, Supply Chain, and related cross-functional 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 regulatory records and documentation related to LVV manufacturing, supply, regulatory compliance, and health authority commitments
- Identify and escalate risks and contribute to mitigation strategies concerning evolving global regulatory expectations
- Participate in continuous improvement and knowledge-sharing activities
- Support assigned regulatory activities under guidance and contribute to timely submissions and responses
- Support development and execution of regulatory strategies for LVV manufacturing processes used in commercial and late-stage clinical cell therapy programs
- Contribute to regulatory assessments and risk management for manufacturing changes, facility transfers, process improvements, and capacity expansion initiatives
- 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 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
- Preferred: 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
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