License Associate III

Key Responsibilities:

• Prepare and compile initial license application dossiers including:
FDA Establishment Registration and Tissue Establishment Registration (21 CFR Part 1271)
EU Manufacturing Authorisation and Tissue Establishment Licence (2004/23/EC, 1394/2007/EC)
PMDA/MHLW Manufacturing and Processing Licence applications (Japanese GMP/GCTP framework)
• Track submission progress and maintain clear communication with health authorities and notified bodies.
• Ensure ongoing compliance with applicable GMP, GTP, and GCTP standards.
• Support audit and inspection readiness activities related to establishment licensing.
• Monitor changes in cell therapy, ATMP, and tissue regulations; provide impact assessments and guidance to management.
• Maintain a global register of active licenses, renewals, and regulatory commitments.
• Serve as the point of contact for FDA, EMA, MHRA, PMDA, and local competent authorities on establishment and tissue-related matters.
• Coordinate with regional consultants and partners to manage local, national and international licensing submissions and renewals.
• Support due diligence activities for partnerships or facility expansions.

Requirements

• Bachelor’s or advanced degree in Life Sciences, Pharmacy, Biotechnology, or Regulatory Affairs.
• Minimum 5 years of experience in Regulatory Affairs within cell therapy, gene therapy, tissue banking, or biologics manufacturing.
• Demonstrated success preparing or managing initial site or establishment license applications across multiple regions.
• Solid understanding of ATMP/biologics manufacturing regulatory frameworks in the USA (FDA), EU (EMA), and Japan (PMDA/MHLW).
• Working knowledge of:
21 CFR Parts 210, 211, 1271 (GMP/GTP – USA)
EU Directives 2001/83/EC, 2004/23/EC, Regulation (EC) 1394/2007 (ATMP – EU)
Japanese GCTP and PMDA Manufacturing Licence Regulations (Japan)