Senior Director, Global Regulatory Lead Neuroscience
Core
Develop global therapeutic regulatory strategies and operational plans for investigational and marketed products in the Neuroscience therapeutic area, serving as the primary interface with health authorities.
Role type
Senior Director, Global Regulatory Lead (Neuroscience)
Builds
Global regulatory plans and strategies for assigned development assets and marketed products
Domain
Pharmaceutical industry, Neuroscience drug development
Required skills
Global regulatory strategy, US and international regulatory environment expertise, drug development lifecycle knowledge, health authority interface, cross-cultural collaboration, complex problem solving
Preferred skills
Advanced degree (MD, PhD, PharmD), experience in neurology/neuromuscular diseases/neuropsychiatry, global experience with EU background, expertise in Drug Development/CMC/Pharmtox/Biopharmaceutics/Clinical/Promotional
Technologies
None stated
Responsibilities
Ensure development and alignment of regulatory strategies across projects; act as regulatory representative on company-wide projects; support due diligence and business development assessments; develop global therapeutic regulatory strategies and operational plans; assemble global regulatory plans for projects/products; evaluate emerging regulations and provide strategic advice; serve as primary interface with health authorities; identify and strategize on regulatory issues impacting projects; work with regulatory product managers and operations for document preparation and submission
Seniority
Senior Director, strategic leadership & cross-functional influence