Regulatory CMC Director – Cell & Gene Therapy

AstraZeneca

. Provide strategic guidance during all stages of product development .

Posted 11/6/2026full-timeUnited StatesLead💰 $186,232 - $279,349 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in global CMC regulatory strategies for cell and gene therapy, with a strong focus on leading cross-functional teams and ensuring submission quality throughout the product lifecycle. Proven ability to navigate complex regulatory environments and develop actionable strategies to meet health authority expectations.

Highest-signal resume keywords

Global CMC Regulatory StrategiesIND, IMPD, BLA FilingsCell/Gene Therapy ExperienceLeadership of Cross-Functional TeamsRegulatory Dossier Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AssessmentsTechnical Risk AssessmentsHealth Authority Briefing DocumentsComparability StrategiesPotency AssaysControl Strategy DevelopmentECTD Publishing ToolsDocument Management SystemsSubmission Quality AssuranceRegulatory Templates Development

Soft Skills

Excellent CommunicationCollaboration SkillsAttention to DetailOutstanding Organizational SkillsAbility to Multitask

Certifications & Qualifications

MA/MS Degree in Life SciencesPhD or PharmD Preferred

Industry Keywords

Cell TherapyGene TherapyCMC RegulationsHealth Authority ExpectationsAccelerated ApprovalsHigh-Growth EnvironmentsMultifunctional TeamsRegulatory ComplianceSubmission ReadinessData-Driven Approaches

About the role

Key responsibilities & impact

Provide strategic guidance during all stages of product development
Lead global CMC regulatory strategies for cell and gene therapy programs
Interpret global regulations and guidance to identify risks
Provide actionable regulatory input to cross-functional product teams
Deliver regulatory assessments for manufacturing changes and quality compliance
Participate in technical risk assessments
Lead CMC components of IND, IMPD, BLA, Master Files, amendments, and annual reports
Develop health authority briefing documents
Represent CMC regulatory affairs on product teams and in agency interactions
Ensure submission quality, clarity, and accuracy
Manage and maintain regulatory dossiers throughout the product lifecycle
Support development, scale-up, and post-approval changes
Develop and maintain regulatory templates, best practices, and procedures
Support hiring, lead workflow, and develop staff
Build and guide high-functioning teams
Champion simplification and data-driven approaches to shorten development cycles and improve submission readiness

Requirements

What you’ll need

Demonstrated ability to develop and maintain strong working relationships with cross-functional teams
Experience participating on and/or leading multifunctional teams
Ability to handle and prioritize multiple projects and work independently
Excellent communication and collaboration skills
Proficient leadership skills to lead complex programs
Ability to build and lead high-functioning teams
Ability to deal with time demands, incomplete information, or unexpected events
Attention to detail
Outstanding organizational skills with ability to multitask and prioritize
MA/MS degree in life sciences required; advanced degree preferred (PhD, PharmD)
10+ years of experience with BS/BA; 8+ years with MS/MA or MBA; 6+ years with PhD
Prior experience in cell/gene therapy
In-depth knowledge of global CMC regulations and evolving challenges and health authority expectations for cell therapies
Experience in IND, IMPD, BLA, and MAA filings
Direct experience leading health authority meetings and negotiating CMC strategies with multiple regions
Expertise in CGT-specific comparability strategies, potency assays, and control strategy development
Familiarity with eCTD publishing tools and document management systems
Track record delivering expedited pathways or accelerated approvals
Experience working across multiple sites and in highly matrixed, high-growth environments
Comfort using analytics or automation to streamline regulatory processes and enhance submission quality

Benefits

Comp & perks

Competitive salary and benefits package
Flexible ways of working to balance personal and work commitments
Face-to-face office collaboration 3 days a week
Short-term incentive bonus opportunity
Eligibility to participate in an equity-based long-term incentive program
Qualified retirement program (401(k) plan)
Paid vacation and holidays
Paid leaves
Medical, prescription drug, dental, and vision coverage