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.
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, health authority interface, drug development process knowledge, cross-cultural collaboration, complex business problem solving
Preferred skills
MD, PhD or PharmD, experience in neurology/neuromuscular diseases/neuropsychiatry, global experience with US and EU background
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 & mentorship