Senior Director, Global Regulatory Lead Neuroscience
Bristol Myers Squibb
Summary
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.
Job description
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.
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
Benefits
- Wellbeing support
- Retirement benefits
- Financial protection benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- Flexible Time Off
- Paid company holidays
- Paid sick leave
- Volunteer days
- Summer hours flexibility
- Leaves of absence
- Global shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.