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Role Description

The License Associate III will lead and coordinate the preparation, submission, and maintenance of initial facility and establishment license applications for drug manufacturing and tissue operations in the United States, European Union, and Japan. This role is pivotal in ensuring the company’s manufacturing sites and partner facilities are fully licensed and compliant with GMP (Good Manufacturing Practice), GTP (Good Tissue Practice), and regional ATMP regulatory frameworks. The successful candidate will collaborate closely with key stakeholders to support global launch readiness and regulatory compliance for advanced therapy products.

• 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.

Qualifications

• 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)

Benefits

• $90,000 - $99,000 a year

Company Description

Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.

At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.

Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.

Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.