Director, Regulatory & Compliance

About the role

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Regulatory & Compliance based in the United States. This is a high-impact leadership role responsible for building and owning a regulatory and compliance function within a fast-growing biotechnology environment. You’ll shape regulatory strategy across the product development and commercial lifecycle, with a focus on U.S. and international requirements. The role combines regulatory affairs, ethics and compliance, privacy governance, and government affairs. You’ll serve as a trusted subject matter expert for executives and cross-functional teams navigating a complex and evolving regulatory landscape. The position offers significant autonomy, with an opportunity to build programs, processes, and governance frameworks largely from the ground up. You’ll work closely with Legal, Quality, IT, Clinical, Engineering, Product, and executive leadership to embed compliance into everyday operations. This fully remote opportunity is suited to a hands-on regulatory leader who can translate complexity into practical, scalable business practices.

Responsibilities

• Build, implement, and maintain the ethics and compliance program, including policies, training, monitoring, reporting, and mechanisms for continuous improvement.
• Develop and execute regulatory strategies across the product development and commercial lifecycle, covering FDA requirements and applicable international frameworks such as EMA and ICH.
• Serve as the primary subject matter expert and liaison for regulatory agency interactions, submissions, inspections, and related communications.
• Monitor changes in regulatory and legislative requirements, including AI/ML guidance, data privacy legislation, and biotechnology-specific frameworks, and assess their impact across the organization.
• Lead internal investigations, audits, corrective actions, and remediation activities related to regulatory and compliance matters.
• Develop and maintain a GDPR-ready data governance framework, including Data Protection Impact Assessments, Records of Processing Activities, and processes supporting data subject rights.
• Establish privacy-by-design practices across product and platform development in partnership with Engineering and Product teams.
• Ensure appropriate privacy governance is maintained across all jurisdictions where the organization operates or processes personal data.
• Lead vendor and third-party data protection due diligence, including Data Processing Agreements and oversight of sub-processor compliance.
• Maintain incident response and data breach management protocols aligned with applicable privacy requirements, including the GDPR 72-hour notification framework.
• Coordinate with Legal and IT Security on privacy incidents, investigations, containment, remediation, and regulatory notifications.
• Report regulatory, compliance, and privacy program developments and readiness metrics to the Chief Legal Officer and, when appropriate, the Board or external stakeholders.
• Partner cross-functionally with Legal