Spatial Biology Specialist

Jobtailor; Deutschland; Remote; EUR 120.000 - 160.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a senior Regulatory CMC lead to develop and drive strategies for cell and gene therapy products across clinical development, regulatory submissions, and post-approval life cycle. You will guide cross‑functional teams and own CMC sections for INDs, CTAs, BLAs, and MAAs with input from external consultants as needed.

Ideal candidates bring 15+ years in biotech/pharma, deep GMP experience, and a proven track record in global regulatory filings and health authority interactions.

Qualifikationen

• Bachelor's degree in life sciences is required.
• 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.

Aufgaben

• 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.

Kenntnisse

CMC Documentation

Regulatory Submission Preparation

INDs

CTAs

BLAs

MAAs

Comparability Assessments

Validation Activities

Technical Justifications

Regulatory Compliance

Ausbildung

Bachelor's degree in life sciences

Jobbeschreibung

• 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