Director, Regulatory & Compliance
Core
Build and own a regulatory and compliance function for a fast-growing biotechnology company, covering FDA submissions, international frameworks, ethics, privacy governance, and government affairs.
Role type
Director, Regulatory & Compliance (Biotechnology)
Builds
Regulatory strategies, ethics and compliance programs, GDPR-ready data governance frameworks, privacy-by-design practices, and incident response protocols.
Domain
Biotechnology / Pharmaceuticals / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy, FDA submissions, international regulatory frameworks (EMA, ICH), ethics and compliance program management, privacy governance, GDPR compliance, data protection impact assessments, privacy-by-design, incident response, vendor due diligence, cross-functional partnership
Preferred skills
International regulatory experience, clinical-stage or early-commercial biotech experience, AI/ML regulatory considerations, government affairs experience, advanced degree (JD, MS, PharmD)
Technologies
None explicitly stated
Responsibilities
Build and maintain ethics and compliance programs; Develop and execute regulatory strategies across product lifecycle; Serve as primary liaison for regulatory agency interactions; Monitor changes in regulatory requirements including AI/ML and data privacy; Lead internal investigations and audits; Establish privacy-by-design practices; Report program developments to executive leadership; Partner cross-functionally to integrate compliance into operations
Seniority
Director, strategic leadership & program building
