Bristol Myers Squibb · 3 days ago
Senior Director, Global Regulatory Lead Neuroscience
Princeton, NJ
Full-time
Onsite
Director/Executive
$227K/yr - $275K/yr
8+ years expBristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. The Senior Director, Global Regulatory Lead Neuroscience will develop and implement regulatory strategies across projects in the Neuroscience therapeutic area, acting as a key representative on various company-wide initiatives and influencing the regulatory environment for assigned projects.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
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
Qualification
Required
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
Benefits
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-01-18
2026-01-16
Company data provided by crunchbase