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Princeton - NJ - US; Princeton Pike - NJ; Cambridge Crossing; San Diego - CA - US; Seattle - WA - US; Brisbane - CA
Source: Bristol Myers Squibb careers · View original posting
From Bristol Myers Squibb's posting. “We” and “our” refer to the employer.
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.
This is work that transforms the lives of patients, and the careers of those who do it.
Sr Director, Global Regulatory Strategy, Neuroscience
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 health authority submissions.
Skills / Requirements
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 specific expert in one or more key areas – Drug Development/CMC/Pharmtox/ Biopharmaceutics/Clinical/Promotional.
Inter-dependent partnering skills, team-oriented and ability to influence outcomes necessary. Sensitivity and experience with non-domestic organizations/cross-cultural environments.
Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
Must be able to innovate, analyze and solve critical/complex business problems.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation
Cambridge Crossing: $258,680 - $313,460 
Princeton - NJ - US: $226,750 - $274,763 
 The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws.
Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
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