- Develop and implement CMC regulatory strategies for clinical development, marketing applications, and post-approval lifecycle management of cell and gene therapy products
- Provide strategic regulatory guidance to cross-functional teams
- Lead preparation, authorship, and review of CMC sections for INDs, CTAs, BLAs, and MAAs, including amendments and responses to health authority queries
- Collaborate with process development, analytical development, regulatory operations, and external consultants on CMC milestones and submission documentation
- Oversee regulatory input on process changes, comparability assessments, validation activities, and technical justifications
- Participate in change control evaluations for regulatory compliance and alignment with registered dossiers
- Support BLA/MAA CMC preparation and readiness for regulatory interactions and marketing authorization
- Represent Regulatory CMC in global health authority meetings
- Prepare briefing packages and participate in formal meetings
- Identify, assess, and communicate CMC regulatory risks and contribute to mitigation planning
Requirements
- Bachelor's degree in life sciences
- At least 15 years of experience in the biotech/pharmaceutical industry
- Extensive knowledge of GMPs and key requirements for CMC documentation for regulatory submissions in ICH regions
- Experience in cell and gene therapy CMC
- Late-stage development and commercial launch experience is mandatory
- Experience reviewing and writing CMC regulatory submission documents for global regulatory filings and related health authority interactions preferred
- Ability to occasionally travel by car and plane
- Ability to handle more than one task at a time and work at a rapid pace while maintaining attention to detail
- Ability to occasionally lift and/or move up to 25 pounds
Core Competencies
Demonstrates extensive expertise in CMC regulatory strategies for cell and gene therapy products, with a strong focus on regulatory submissions, compliance, and cross-functional collaboration. Proven ability to lead the preparation and review of CMC documentation for INDs, CTAs, BLAs, and MAAs while effectively managing regulatory risks.
Highest-signal resume keywords
- CMC Regulatory Strategy Development
- Cell And Gene Therapy CMC Experience
- GMP Knowledge
- Regulatory Submission Documentation
- Late-Stage Development Experience
ATS Optimization Keywords
Hard Skills
- CMC Documentation
- Regulatory Submission Preparation
- INDs
- CTAs
- BLAs
- MAAs
- Comparability Assessments
- Validation Activities
- Technical Justifications
- Regulatory Compliance
Soft Skills
- Attention To Detail
- Multitasking
- Communication
- Collaboration
- Risk Assessment
Industry Keywords
- Biotech
- Pharmaceutical
- GMPs
- ICH Regions
- Health Authority Interactions
- Change Control Evaluations
- Regulatory Risks
- Marketing Authorization
- Global Regulatory Filings
- Post-Approval Lifecycle Management
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Spatial Biology Specialist Arbeitgeber: Jobtailor
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