Senior Director, Global Regulatory Lead Neuroscience
About The Position
The Senior Director, Global Regulatory Lead Neuroscience is a key member of the GRSP Extended Leadership Team, ensuring the development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area. The role also represents regulatory affairs on company-wide projects and initiatives and supports due diligence and business development assessments. Working with regional regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead for assigned development assets and marketed products, this position develops global therapeutic regulatory strategies and operational plans, reviews and advises on product development plans, and assembles global regulatory plans. The role provides strategic and operational advice to development and commercialization teams, serves as the primary global point of contact for assigned projects, and acts as the primary interface with health authorities. The Senior Director evaluates emerging regulations and changes in the regulatory landscape, identifies issues affecting BMS, regulatory affairs, or assigned projects, and develops strategies to address them. The role collaborates with regulatory product managers and regulatory operations to prepare, produce, and submit health authority documents using internal and external resources, and works with regional international staff on submissions.
Requirements
- Advanced degree in a scientific discipline.
- 8–12 years of pharmaceutical industry experience, including 6–8 years in regulatory affairs.
- Thorough knowledge of the drug research, development, and commercialization process.
- Demonstrated expertise in one or more key areas, such as drug development, CMC, pharmacology and toxicology, biopharmaceutics, clinical, or promotional.
- Interdependent partnering skills, a team-oriented approach, and the ability to influence outcomes.
- Sensitivity and experience working with non-domestic organizations and cross-cultural environments.
- Excellent organizational, communication, and time-management skills to manage multiple ongoing projects simultaneously.
- Ability to innovate, analyze, and solve critical or complex business problems.
Nice To Haves
- MD, PhD, or PharmD preferred.
- Experience in neurology, neuromuscular diseases, or neuropsychiatry drug development strongly preferred.
- Global experience strongly preferred, with command of US experience and an EU background desired.
Responsibilities
- Ensure development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area as a member of the GRSP Extended Leadership Team.
- Represent regulatory affairs 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, working with regional regulatory staff.
- Develop global therapeutic regulatory strategies and operational plans for identified investigational and marketed products.
- Review and provide counsel on product development plans.
- Assemble global regulatory plans for assigned projects and products.
- Provide strategic and operational advice to development and commercialization teams and serve as the primary global point of contact for assigned projects.
- Evaluate emerging regulations and changes in the regulatory landscape and advise on their impact on assigned projects.
- Serve as the primary interface with health authorities for assigned projects.
- Identify issues affecting BMS, regulatory affairs, or projects and develop strategies to address them.
- Work with regulatory product managers and regulatory operations to prepare, produce, and submit health authority documents using internal and external resources.
- Work with regional international staff on health authority submissions.
Benefits
- Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to applicable plan terms and eligibility.
- U.S.-based exempt employees are eligible for Flexible Time Off without a set accrual limit, subject to manager approval.
- 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, and 3 optional holidays.
- Depending on eligibility, additional time-off benefits may include paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves for medical, personal, parental, caregiver, bereavement, or military needs.
- Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
- May be eligible for additional discretionary incentive cash and stock opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
