Posted 3 months ago

License Associate III

RemoteRemoteFull-time

AI Summary

Leads preparation, submission, and maintenance of initial facility and establishment license applications for drug manufacturing and tissue operations across US, EU, and Japan, ensuring GMP/GTP/GCTP compliance and regulatory readiness.

About this role

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel (CAP-1002), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most.

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.

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)

Skills

21 CFR Parts 210, 211, 1271ATMP Regulatory FrameworksDue DiligenceEU Directive 2004/23/ECEU Directives 2001/83/ECEU Manufacturing AuthorisationFDA Establishment RegistrationGCTPGlobal Regulatory CoordinationGMPGTPLicensing SubmissionsPMDA/MHLW Manufacturing LicencePMDA/MHLW RegulationsRegulation 1394/2007/ECRegulatory Affairs LeadershipRegulatory SubmissionsTissue Establishment LicenceTissue Establishment Registration

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