Regulatory Cmc Specialist

About the Role

We are seeking a highly motivated Regulatory Affairs CMC Specialist to support global regulatory activities for an innovative gene therapy product in clinical development (Phase I–III) .

The successful candidate will contribute to the preparation and lifecycle management of CMC regulatory documentation , ensuring compliance with EU and global regulatory requirements for advanced therapies (ATMPs).

Key Responsibilities

CMC Regulatory Strategy & Execution

• Support the development and implementation of global CMC regulatory strategies for gene therapy products in clinical phases
• Contribute to regulatory submission planning , including IND/IMPD, CTA, BLA/MAA components (CMC sections)
• Ensure alignment of CMC documentation with current regulatory guidelines (EMA, FDA, ICH)

Regulatory Submissions

• Prepare, review, and compile Module 3 (Quality) sections of regulatory dossiers
• Support submission of:
• Clinical Trial Applications (CTA) / INDs / IMPDs
• Scientific Advice / Regulatory briefing packages
• Amendments, variations, and annual reports
• Coordinate responses to health authority questions related to CMC

CMC Documentation & Compliance

• Ensure consistency and accuracy of CMC data across regulatory submissions
• Maintain oversight of:
• Drug substance and drug product information
• Manufacturing processes (viral vectors, cell banks)
• Analytical methods and specifications
• Stability data and comparability studies
• Track and assess CMC changes and their regulatory impact

Cross-functional Collaboration

• Interface with CMC, Quality, Manufacturing, and Clinical teams
• Support interactions with CMOs/CDMOs
• Contribute to regulatory intelligence activities for ATMPs

Health Authority Interactions

• Assist in preparation for meetings with regulatory agencies (EMA, national agencies, FDA)
• Support documentation for Scientific Advice and Paediatric Investigation Plans (PIPs) where applicable

Qualifications

• Master’s or PhD in Life Sciences, Pharmacy, Biotechnology, or related field

Experience

• 3–6 years of experience in Regulatory Affairs CMC
• Experience with biologics or advanced therapies (gene therapy, cell therapy, viral vectors)
• Experience supporting clinical-stage regulatory submissions

Technical Skills

• Strong knowledge of:
• CMC requirements for biologics/ATMPs
• ICH guidelines (Q5, Q6, Q8–Q12)
• EU Clinical Trial Regulation (CTR)
• Familiarity with eCTD format and submission systems

Preferred Qualifications

• Experience with AAV, lentiviral vectors, or other gene delivery platforms
• Experience with comparability exercises and process changes
• Prior interaction with EMA or national competent authorities
• Knowledge of GMP requirements for ATMPs