Director, RA Global Regulatory Strategy
Core
Develops and implements global regulatory strategies to secure and maintain market approval for pharmaceutical products in assigned therapeutic areas.
Role type
Senior IC Director, Global Regulatory Strategy
Builds
Global regulatory dossiers, risk assessment and mitigation strategies, and product lifecycle documentation
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory strategy development, drug development lifecycle management, cross-functional stakeholder leadership, risk assessment and mitigation, regulatory policy formulation, executive communication, project management, matrix environment navigation
Preferred skills
Multi-region regulatory experience (EU, Japan), advanced degree in life sciences, business acumen, industry association leadership
Technologies
Regulatory submission systems, risk assessment frameworks
Responsibilities
Lead the Global Regulatory Product Team to develop creative global strategies aligned with regulations; Ensure strategic messaging in global regulatory dossiers and responses to agency requests; Proactively lead risk assessment and mitigation strategy development; Influence the development of regulations and guidance by analyzing legislation; Present meaningful regulatory assessments and recommendations to executive management; Manage project resourcing and budget allocations
Seniority
Director, strategic leadership with direct reports
