Senior Director, Global Regulatory Lead Neuroscience

Regulatory Toolkit; Princeton (NJ); On-site; USD 227,000 - 275,000; Full time

Benefits offered by this job

Wellbeing support

Flexible Time Off

Company holidays

Paid vacation

Global Shutdown

Job summary

Bristol Myers Squibb seeks a Sr Director, Global Regulatory Strategy in Neuroscience to lead regulatory strategy development, coordinate across projects, and liaise with health authorities worldwide. The role drives global regulatory plans, supports due diligence, and partners with US and international teams to influence development and commercialization decisions.

Ideal candidates bring advanced scientific degrees with 8–12 years in pharma regulatory affairs, including global experience in

Qualifications

• Advanced degree in scientific discipline; MD, PhD or PharmD preferred.
• 8–12 years pharma industry experience, including 6–8 years in regulatory affairs.
• Global regulatory experience with US/EU background is highly preferred.
• Expertise in Drug Development/CMC/Pharmtox/Biopharmaceutics/Clinical/Promotional areas.

Responsibilities

• Develop global regulatory strategies and plans for identified projects/assets.
• Interface with health authorities and serve as primary global point person for assigned projects.
• Lead regulatory submissions and align strategies across Neuroscience programs.
• Collaborate with regional staff on global/regional regulatory activities.

Skills

Regulatory leadership

Global regulatory

Neurology experience

US/EU regulatory

Strategic thinking

Leadership

Communication

Education

Advanced degree in science (MD/PhD/PharmD)

Job description

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.

Compensation Overview

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.

Benefits

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
• U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1603594 : Senior Director, Global Regulatory Lead Neuroscience