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 models.
Role type
Senior Director, Regulatory Affairs Management
Builds
Global regulatory submission models and organizational capability for infectious disease products
Domain
Biopharmaceuticals / Infectious Diseases
Deliverable
client delivery
Required skills
Global regulatory strategy, team leadership and development, project and portfolio management, cross-functional alignment, risk assessment, budget management, stakeholder influence
Preferred skills
Infectious disease product experience (vaccines, antivirals, antibacterials, monoclonal antibodies), advanced degree, commercial acumen, facilitation skills
Technologies
None stated
Responsibilities
Oversee regulatory project management and operational delivery; Lead and develop the Regulatory Affairs Management team; Define and implement regulatory submission models; Ensure regulatory milestones and compliance activities are delivered; Build partnerships with health authorities; Drive cross-functional alignment; Lead strategic planning and resource coordination; Monitor evolving regulatory requirements; Develop global regulatory policies and processes
Seniority
Senior Director, strategic leadership & team management