Regulatory CMC Specialist - Lombardy - Discover International

    Discover International
    Discover International Lombardy

    1 giorno fa

    Descrizione

    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
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