Senior Director, Regulatory Affairs Management – Infectious Diseases
Core
Lead and develop the Regulatory Affairs Management team for the Infectious Disease portfolio, setting strategic direction for global regulatory delivery and submission compliance.
Role type
Senior Director, Regulatory Affairs Management (Infectious Diseases)
Builds
Global regulatory submission models, compliant product submissions, and high-performing regulatory teams
Domain
Biopharmaceuticals / Infectious Diseases / Regulatory Affairs
Required skills
Global regulatory strategy, team leadership and development, project and portfolio management, cross-functional alignment, risk assessment, budget forecasting, stakeholder influence, process improvement
Preferred skills
Infectious disease product experience (vaccines, antivirals, antibacterials, monoclonal antibodies), advanced degree, commercial acumen, facilitation of governance forums
Technologies
Regulatory Operating Models, automation tools, data analytics platforms
Responsibilities
Oversee regulatory project management for development-stage and approved products; lead team development through coaching and succession planning; define and implement submission models; ensure milestone delivery and compliance; build partnerships with health authorities; drive cross-functional alignment; manage departmental costs and budget targets; develop global regulatory policies and capabilities.
Seniority
Senior Director, strategic leadership & people management