Capricor Therapeutics

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. 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.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description Capricor is seeking a Senior Director of Medical Affairs with deep expertise in biotechnology, ideally in rare diseases or cell therapies. This position will play a pivotal role in building the medical affairs function as we advance our lead programs following recent clinical milestones. - Define the roadmap for our scientific narrative. - Drive clinical scientific messaging. - Foster key relationships with healthcare professionals (HCPs), key opinion leaders (KOLs), and patient advocacy groups in the DMD and BMD communities. - Ensure high-integrity, compliant processes for stakeholder engagement. - Lead cross-functional efforts to bridge clinical development with commercialization readiness. - Foster deep relationships and evidence generation strategies necessary to drive program success and ongoing medical excellence. Qualifications - MD required, with experience in neurology, myology, cardiology, or a closely related field, and demonstrated clinical scientific competence. - Deep experience and commitment to excellence in medical affairs, with a proven track record in biotechnology or pharmaceuticals. - Experience working in a small company environment, thriving in dynamic, resource-constrained settings. - Passionate "can-do" mentality with evidence of high emotional intelligence (EQ) and collaborative teamwork. - Exceptional communication, presentation, and interpersonal skills to engage stakeholders at all levels. - Strong understanding of regulatory compliance, including cGMP, ICH, and FDA guidelines. - Ability to work independently, multi-task, and meet aggressive deadlines in a fast-paced environment. - Willingness to travel up to 30-40% for meetings, site visits, and conferences. Requirements - Previous experience with DMD, BMD, or other muscle or cardiomyopathic indications. - Experience with pre-launch or commercialization activities in a Medical Affairs capacity. - Experience with complex cell or gene therapy (ATMP) products. Benefits - $300,000 - $350,000 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.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description As a Clinical Quality Assurance – GCP Specialist, you will support GCP compliance for clinical operations to ensure regulatory adherence. You will assist in compliance processes and collaborate with cross-functional teams to maintain clinical trial integrity. - Develop, implement, and maintain systems to ensure GCP compliance. - Provide GCP support to clinical study teams to reduce compliance risks. - Collaborate with Quality Assurance, Regulatory Affairs, and Clinical teams to develop GCP-compliant policies and SOPs. - Support eTMF oversight, performing compliance checks and developing risk mitigation strategies. - Support inspection readiness activities and trial-specific training. - Assess and document Clinical Operations process deviations. - Collaborate with clinical trial teams to identify and improve operational processes. - Interact with Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety & PV, Clinical Supply, and clinical vendors. - Manage clinical CAPAs and conduct root cause investigations for deviations. - Support compliance assessment, mitigation, and change control processes. - Review essential documents (e.g., Clinical Protocols, Informed Consent Forms, Investigator’s Brochures, DSURs, Clinical Study Reports) for GCP adherence. - Perform other duties as assigned. Qualifications - Bachelor’s degree in a scientific or related discipline, or 5 years of equivalent experience. - 3-5 years of eTMF experience, including study start-up, maintenance, and quality reviews. - 3+ years of experience in pharmaceutical industry roles related to clinical trials (e.g., clinical operations, project management). - Experience in quality assurance or quality management activities. - GCP Specialist experience with GCP vendor and site audits preferred. - Ability to manage projects and tasks in a fast-paced environment. - Analytical and critical thinking skills for quality review decision-making. - Knowledge of pharmaceutical industry standards, including ICH/GCP guidelines. - Experience with BIMO inspections preferred; EMA/MHRA/PDMA experience a plus. - Communication skills, both verbal and written. - Leadership and problem-solving skills. - Ability to translate strategy into operations and manage multiple priorities. - Ability to work independently with limited supervision. Requirements - Primarily office-based with required time in clinical trial settings addressing compliance and documentation. - Requires prolonged periods of computer use for data analysis, documentation, and report generation related to compliance processes. - May involve lifting office materials up to 20 pounds. - Ability to navigate office and clinical environments for audits and training activities. Benefits - $109,000 - $117,500 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.