Global Neuroscience Regulatory Strategy Director

Bristol-Myers Squibb Co; Princeton (NJ); Hybrid; USD 227,000 - 275,000; Full time

Benefits offered by this job

Comprehensive benefits package

Flexible time off

Job summary

Bristol Myers Squibb is seeking a Senior Director, Global Regulatory Strategy in Neuroscience to lead development and alignment of regulatory strategies across projects in neuroscience. You will work with the GRSP Leadership Team and serve as the primary interface with health authorities worldwide.

Responsibilities include developing global regulatory plans, advising development teams, and coordinating submissions with regional and global regulatory staff.

Qualifications

• Advanced degree in scientific discipline; MD, PhD or PharmD preferred, experience in neurology, neuromuscular diseases or neuropsychiatry drug development strongly preferred.
• 8-12 years pharmaceutical industry experience, including 6-8 years in regulatory affairs. Global experience strongly preferred with command of US experience and EU background desired.
• Thorough knowledge of the drug research, development, and commercialization process.
• Demonstrated expert in Drug Development/CMC/Pharmtox/Biopharmaceutics/Clinical/Promotional.
• Inter-dependent partnering skills in cross-cultural environments and ability to influence outcomes.
• Excellent organizational, communication and time management skills to manage multiple ongoing projects.

Responsibilities

• Develop global regulatory strategies and operational plans for identified projects/products.
• Review and provide counsel on product development plans.
• Assemble global regulatory plans for identified projects/products.
• Serve as primary global point person for assigned projects with health authorities.
• Interface with health authorities on assigned projects.
• Collaborate with regulatory product managers and regulatory operations for preparation, production and submission of health authority documents.
• Coordinate with regional international staff for health authority submissions.

Skills

Regulatory strategy

Global regulatory leadership

Regulatory submissions

Cross-functional collaboration

US/EU regulatory experience

Education

MD/PhD/ PharmD preferred

Job description

Bristol Myers Squibb is seeking a Senior Director, Global Regulatory Strategy in Neuroscience to lead development and alignment of regulatory strategies across projects in neuroscience. You will work with the GRSP Leadership Team and serve as the primary interface with health authorities worldwide.

Responsibilities include developing global regulatory plans, advising development teams, and coordinating submissions with regional and global regulatory staff.