License Associate III

Capricor Therapeutics, Inc.

License Associate III managing regulatory compliance and licensing for cell therapy products at Capricor Therapeutics focusing on USA, EU, and Japan regulations.

Posted 6/29/2026full-time🇺🇸 United StatesJuniorMid-Level💰 $90,000 - $99,000 per yearWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Capricor Therapeutics, Inc. Website LinkedIn All Job Openings 51 - 200 employees Founded 2005 🧬 Biotechnology 💊 Pharmaceuticals 🔬 Science Biotechnology
Pharmaceuticals
Science Capricor Therapeutics, Inc. is a clinical-stage biotechnology company developing cell- and exosome-based therapeutics, focused on precision medicine for Duchenne muscular dystrophy and other serious diseases. The company advances allogeneic cardiosphere-derived cells (CDCs) and exosome platforms across a multi-stage pipeline, including investigational cell therapy (deramiocel) and approaches for loading therapeutic oligonucleotides into exosomes. Capricor emphasizes patient-focused development, translational research, and strategic partnerships to bring novel biologic medicines to patients. License Associate III Job not on LinkedIn 🔥 26 minutes ago 🏢🏡 null – Hybrid 💵 $90k - $99k / year ⏰ Full Time 🟢 Junior 🟡 Mid-level ✨ Associate Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
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) Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Associate, Innovation – Physical Sciences 🔥 1 hour ago NobleReach Foundation 11 - 50 Website LinkedIn All Job Openings Associate providing technical and operational support to early-stage ventures at NobleReach Foundation. Tasks include data analysis, content creation, and supporting commercialization strategies for portfolio ventures. 🏢🏡 Tysons Corner – Hybrid 💵 $80k - $95k / year ⏰ Full Time 🟢 Junior 🟡 Mid-level ✨ Associate Associate, Valuations 🔥 1 hour ago Bellwether 51 - 200 Website LinkedIn All Job Openings Associate on Valuations Team managing evaluations of commercial real estate investments. Conducting analyses and reporting performance metrics for Bellwether's portfolio. 🏢🏡 El Segundo – Hybrid 💵 $110k - $120k / year ⏰ Full Time 🟢 Junior 🟡 Mid-level ✨ Associate 🦅 H1B Visa Sponsor Associate, Programmatic - Auto 🔥 1 hour ago Canvas Worldwide 201 - 500 🤝 B2B 🛍️ eCommerce 📱 Media Website LinkedIn All Job Openings Associate responsible for managing programmatic ad campaigns at Canvas Worldwide. Collaboration with teams on campaign strategy and optimization using demand side platforms. 🏢🏡 El Segundo – Hybrid 💵 50k / year ⏰ Full Time 🟢 Junior 🟡 Mid-level ✨ Associate Audit Associate 🔥 1 hour ago Aprio 1001 - 5000 💸 Finance 🤝 B2B ☁️ SaaS Website LinkedIn All Job Openings Audit Associate role maximizing client opportunities at Aprio, a top 20 CPA and advisory firm. Join a dynamic team supporting audits and client relationships. 🏢🏡 Bala Cynwyd – Hybrid 💰 Debt Financing on 2018-10 ⏰ Full Time 🟢 Junior 🟡 Mid-level ✨ Associate 🦅 H1B Visa Sponsor Civil Associate, Transportation 🔥 2 hours ago Michael Baker International 1001 - 5000 Website LinkedIn All Job Openings Civil Associate supporting local and regional transportation projects in San Diego, CA. Assisting experienced engineers while gaining hands-on experience in civil engineering. 🏢🏡 San Diego – Hybrid 💵 $75k - $95k / year ⏰ Full Time 🟢 Junior 🟡 Mid-level ✨ Associate 🦅 H1B Visa Sponsor 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

Regulatory FrameworksLicense Application PreparationImpact AssessmentAudit ReadinessSubmission Tracking

Soft Skills

Clear CommunicationCollaboration with Consultants

Certifications

Bachelor’s Degree in Life SciencesAdvanced Degree in Regulatory Affairs