Senior Director, Global Regulatory Lead Neuroscience
Bristol Myers Squibb
5 months ago
Remote friendly (Lawrence, NJ)
United States
Corporate Functions
Sr Director, Global Regulatory Strategy, Neuroscience
Responsibilities:
- Key member of the GRSP Extended Leadership Team to develop, implement, and align regulatory strategies across projects and the Neuroscience therapeutic area.
- Act as regulatory representative on company-wide projects and initiatives.
- Support due diligence and business development assessments.
- Serve as Global Regulatory Lead and US Regional Regulatory Lead for assigned development assets and marketed products.
- Develop global therapeutic regulatory strategies and operational plans; review/provide counsel on product development plans.
- Assemble global regulatory plans for identified projects/products.
- Provide strategic and operational advice to development and commercialization teams; primary global point of contact.
- Evaluate emerging regulations and regulatory landscape changes; advise on impacts.
- Primary interface with health authorities for assigned projects.
- Identify issues impacting BMS/regulatory affairs/projects and provide strategies.
- Partner with regulatory product managers and regulatory operations to prepare/produce/submit health authority documents using internal/external resources; coordinate with international staff.
Qualifications / Requirements:
- Advanced degree in scientific discipline; MD, PhD, or PharmD preferred. Strong preference: neurology, neuromuscular diseases, or neuropsychiatry drug development.
- 8–12 years pharmaceutical industry experience, incl. 6–8 years in regulatory affairs. Global experience strongly preferred; US experience required; EU background desired.
- Thorough knowledge of drug research, development, and commercialization.
- Expert in one or more areas: Drug Development, CMC, Pharmtox, Biopharmaceutics, Clinical, Promotional.
- Strong partnering skills; ability to influence outcomes; experience with non-domestic organizations/cross-cultural environments.
- Excellent organizational, communication, and time management skills.
- Ability to innovate, analyze, and solve complex business problems.
Benefits (as stated):
- Health Coverage (medical/pharmacy/dental/vision); Wellbeing support (incl. EAP); Financial protection (401(k), disability, life/accident insurance, etc.).
- Paid time off: flexible time off for US exempt employees; or 160 hours annual paid vacation + national/optional holidays for certain Phoenix/Puerto Rico/Rayzebio roles.
Application instruction:
- If interested but not a perfect resume match, encouraged to apply anyway.
Responsibilities:
- Key member of the GRSP Extended Leadership Team to develop, implement, and align regulatory strategies across projects and the Neuroscience therapeutic area.
- Act as regulatory representative on company-wide projects and initiatives.
- Support due diligence and business development assessments.
- Serve as Global Regulatory Lead and US Regional Regulatory Lead for assigned development assets and marketed products.
- Develop global therapeutic regulatory strategies and operational plans; review/provide counsel on product development plans.
- Assemble global regulatory plans for identified projects/products.
- Provide strategic and operational advice to development and commercialization teams; primary global point of contact.
- Evaluate emerging regulations and regulatory landscape changes; advise on impacts.
- Primary interface with health authorities for assigned projects.
- Identify issues impacting BMS/regulatory affairs/projects and provide strategies.
- Partner with regulatory product managers and regulatory operations to prepare/produce/submit health authority documents using internal/external resources; coordinate with international staff.
Qualifications / Requirements:
- Advanced degree in scientific discipline; MD, PhD, or PharmD preferred. Strong preference: neurology, neuromuscular diseases, or neuropsychiatry drug development.
- 8–12 years pharmaceutical industry experience, incl. 6–8 years in regulatory affairs. Global experience strongly preferred; US experience required; EU background desired.
- Thorough knowledge of drug research, development, and commercialization.
- Expert in one or more areas: Drug Development, CMC, Pharmtox, Biopharmaceutics, Clinical, Promotional.
- Strong partnering skills; ability to influence outcomes; experience with non-domestic organizations/cross-cultural environments.
- Excellent organizational, communication, and time management skills.
- Ability to innovate, analyze, and solve complex business problems.
Benefits (as stated):
- Health Coverage (medical/pharmacy/dental/vision); Wellbeing support (incl. EAP); Financial protection (401(k), disability, life/accident insurance, etc.).
- Paid time off: flexible time off for US exempt employees; or 160 hours annual paid vacation + national/optional holidays for certain Phoenix/Puerto Rico/Rayzebio roles.
Application instruction:
- If interested but not a perfect resume match, encouraged to apply anyway.