Director, Regulatory Affairs
Core
Lead cross-business regulatory initiatives, influence changing regulations, and manage domestic and international regulatory information to ensure compliance and strategic alignment.
Role type
Director, Regulatory Affairs (Strategy & Leadership)
Builds
Corporate regulatory strategies, consensus on regulatory positions, and cross-business regulatory councils
Domain
Healthcare (Medical Devices, Diagnostics, Nutritionals, Pharmaceuticals)
Deliverable
dashboards & analysis
Required skills
Regulatory policy development, stakeholder negotiation, strategic planning, risk-benefit analysis, cross-functional leadership, regulatory document writing, industry association engagement
Preferred skills
Advanced degree (MS/PhD/Law), experience in quality assurance or R&D, scientific background (biology, chemistry, engineering)
Technologies
Regulatory databases, compliance management systems
Responsibilities
Lead cross-business regulatory council and committees; draft and submit responses to regulatory agencies; anticipate emerging regulatory issues and develop solutions; advise management on regulatory risk-benefit; participate in developing new regulations and standards; mentor less-experienced staff
Seniority
Director, strategic leadership with 1 direct report