Director, Regulatory Strategist
Core
Develop and implement global regulatory strategies for complex pharmaceutical products, leading regulatory teams and managing interactions with Health Authorities to ensure product development and approval.
Role type
Senior Director, Global Regulatory Strategist
Builds
Global regulatory strategies and submission packages for originator and established products
Domain
Healthcare / Pharmaceuticals / Regulatory Affairs
Required skills
Global regulatory strategy, Health Authority negotiation, cross-functional leadership, regulatory submission management, risk mitigation, strategic planning
Preferred skills
Advanced scientific degree (Ph.D., Pharm.D., M.D., M.Sc.), MBA, experience managing multiple products across lifecycle stages
Technologies
Regulatory submission systems, dossier management tools
Responsibilities
Develop global/regional regulatory strategies for complex projects; Lead global Regulatory Teams; Manage preparation and submission of applications to regulatory agencies; Partner with clinical, safety, and medical teams; Negotiate product labels with Health Authorities; Ensure compliance with marketing authorization requirements
Seniority
Director, strategic leadership with hands-on execution