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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 filings and strategies for cell therapy products, with a strong focus on lentiviral vector manufacturing and compliance. Proven ability to collaborate cross-functionally and manage regulatory documentation and health authority interactions effectively.
Highest-signal resume keywords
CMC Regulatory FilingsLentiviral Vector ManufacturingRegulatory Strategy DevelopmentHealth Authority InteractionsCell and Gene Therapy Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory RequirementsICH GuidelinesProcess ValidationQuality AttributesAnalytical CharacterizationLifecycle ManagementComparability AssessmentsControl Strategy DevelopmentViral Vector Product CharacterizationChange Control Assessment
Soft Skills
Strong Communication SkillsAttention to DetailOrganizational SkillsCross-Functional CollaborationProactive Mindset
Industry Keywords
Cell TherapyGene TherapyATMP ProgramsRegulatory SubmissionsViral Vector Safety AssessmentsAdventitious Agent ControlManufacturing ChangesInspection ReadinessSupply Chain ManagementContinuous Improvement
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 lentiviral vectors and critical raw materials
- Assist with 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 lentiviral vector operations
- Contribute to inspection readiness activities and prepare supporting facility documentation
- Maintain 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 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
- 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 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 by 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