Compliance

• Will be a key member of the GRSP Extended Leadership Team to ensure the development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area.
• Acts as regulatory representative on various company-wide projects and initiatives.
• Support due diligence and business development assessments.
• Working with regional regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead on assigned development assets and marketed products.
• Develop global therapeutic regulatory strategies and operational plans for identified investigational and marketed products.
• Review/provide counsel on product development plans.
• Assemble the global regulatory plans for identified projects/products.
• Influences and imparts broad expertise regarding US and international regulatory environment.
• Provides strategic and operational advice to the development and commercialization teams, serving as the primary global point person for assigned projects.
• Evaluates emerging regulations and changing regulatory landscape for impact and provides strategic advice for assigned projects.
• Serve as the primary interface with health authorities on assigned projects.
• Identifies issues or is assigned projects that will impact BMS, regulatory affairs or projects and provides strategies for dealing with them.
• Works with the regulatory product managers (submissions) and regulatory operations group, for preparation, production and submission of health authority documents using internal & external resources.
• Works with regional international staff for diverse health authority submissions.

Senior Director, Global Regulatory Lead – Neuroscience

Director, Ethics and Compliance Investigations

Regulatory Engineer

Executive Director, Regulatory Science & Strategy – Oncology

Director, Global Regulatory Leader

Director, Global Regulatory Leader