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.
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