Director, Regulatory & Compliance

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.

Accountabilities:

• 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, Quality, IT, Clinical, Engineering, Product, and other teams to integrate regulatory and compliance considerations into business operations.
• Translate complex regulatory requirements into clear, practical guidance for executives and non-specialist stakeholders.

Requirements:

• 14+ years of experience spanning regulatory affairs and/or compliance within biotechnology, pharmaceuticals, or another highly regulated industry.
• Hands-on experience with FDA submissions and regulatory agency interactions; international regulatory experience is a plus.
• Demonstrated ability to build or significantly scale regulatory and compliance programs rather than simply maintain established processes.
• Strong understanding of regulatory strategy, ethics and compliance, privacy governance, and applicable regulatory frameworks.
• Experience developing policies, training programs, monitoring processes, reporting mechanisms, and compliance governance structures.
• Working knowledge of GDPR requirements, including DPIAs, ROPAs, data subject rights, privacy-by-design, DPAs, breach response, and third-party data protection oversight.
• Ability to monitor emerging regulatory developments and translate their implications into actionable business guidance.
• Comfortable operating with a high degree of autonomy and without a large supporting team; strong builder and self-starter mentality.
• Excellent communication skills, with the ability to explain complex regulatory topics clearly to executives, cross-functional teams, and other non-specialist stakeholders.
• Strong judgment, organizational skills, and ability to manage multiple regulatory and compliance priorities in a fast-paced environment.
• Bachelor’s degree in a scientific or legal discipline; an advanced degree such as a JD, MS, or PharmD is preferred.
• Experience in a clinical-stage or early-commercial biotechnology environment is a plus.
• Familiarity with regulatory considerations related to AI/ML applications in drug discovery is beneficial.
• Government affairs, public policy, or regulatory policy engagement experience is a plus.
• Must have legal authorization to work in the United States.

Benefits:

• $195,000-$240,000 base salary.
• Equity opportunities.
• Annual bonus potential.
• Medical, dental, and vision insurance.
• Unlimited vacation.
• Parental leave.
• Employee assistance program.
• Voluntary life and disability insurance.
• 401(k) plan with a generous company match.
• Fully remote work environment.
• Opportunity to build and lead a regulatory and compliance function with broad organizational impact.
• Significant exposure to regulatory strategy, privacy governance, ethics and compliance, and emerging AI/ML considerations in biotechnology.