Corporate Compliance Officer

Responsibilities

• responsibilities include but are not limited to:
 
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.