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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.

The Corporate Compliance Officer is responsible for leading, developing, and overseeing the company’s comprehensive corporate compliance program, with a primary focus on internal compliance, trade compliance, reporting requirements, document retention, quality compliance, anti‑corruption, data privacy and industry standards in the pharmaceutical/biotech sector. Reporting to the Executive Vice President‑General Counsel, this role partners closely with Commercial, Clinical, CMC, Quality, Regulatory, and Operations to ensure all company activities align with applicable laws, regulations, contractual obligations, and ethical standards. The ideal candidate is a seasoned compliance professional with deep pharmaceutical or biotech experience, proven leadership in building and managing compliance programs, with experience in international trade compliance involving Europe and/or Japan.

Responsibilities Compliance Program Leadership & Governance

• Design, implement, maintain, and continuously improve Capricor’s corporate compliance program, including policies, procedures, risk assessments, monitoring, and auditing frameworks
• Assist in the development, implementation, and updating of corporate policies, SOPs, and legal processes
• Lead the development and delivery of compliance training and communications across the organization
• Oversee compliance monitoring, internal investigations, corrective actions, and reporting to senior leadership and the Board as needed
• Maintain and enhance compliance tools, playbooks, dashboards, and processes to support scalability

Commercialization Readiness

• Provide strategic compliance guidance on commercialization planning, including distribution, supply chain, marketing, field operations, patient support programs, and HCP/payer engagements
• Ensure promotional materials, scientific exchange, pre‑approval communications, medical affairs activities, and vendor interactions comply with FDA, EMA, Sunshine Act, Anti‑Kickback Statute, False Claims Act, and other relevant laws
• Review commercial, medical, and vendor‑related materials and activities for regulatory and compliance risk

International Trade Compliance (Europe and/or Japan)

• Oversee compliance with U.S. and foreign export controls, sanctions regimes (OFAC, EU, Japan), customs regulations, and trade agreements relevant to Capricor’s operations and partnerships in Europe and/or Japan
• Manage classification, licensing, and documentation for cross‑border transfers of technology, biological materials, data, and equipment
• Conduct due diligence and risk assessments for international transactions, partnerships, and clinical/commercial activities in these regions

Third‑Party & Vendor Compliance Oversight

• Lead third‑party risk management, including anti‑corruption due diligence (FCPA/UK Bribery Act/Japanese regulations), screening, contracting requirements, and ongoing monitoring
• Collaborate with Procurement, CMC, Manufacturing, Quality, and International teams to ensure third‑party obligations meet compliance and operational standards
• Address vendor compliance issues, disputes, and audit findings

Corporate, Operational & Risk Support

• Partner on data privacy (GDPR, CCPA, etc.), confidentiality, information governance, and cybersecurity compliance initiatives
• Support audit readiness, regulatory inspections, and third‑party assessments
• Advise on emerging regulatory and compliance trends in the pharma/biotech industry and communicate implications to stakeholders

Requirements

• Bachelor’s degree required; J.D. preferred
• 10+ years of progressive compliance experience in the pharmaceutical or biotechnology industry, with at least 5 years in a leadership role overseeing compliance programs
• Demonstrated experience managing international trade compliance matters involving Europe and/or Japan (export controls, sanctions, customs, technology transfer, or equivalent)
• Deep knowledge of compliance laws and industry codes
• Experience supporting commercialization and launch‑stage activities in biotech/pharma strongly preferred
• Proven ability to build and lead compliance functions in dynamic, fast‑paced environments
• Strong risk assessment, investigation, and issue‑management skills
• Excellent communication, influence, and cross‑functional collaboration abilities