Senior Director, Global Regulatory Lead Neuroscience
About The Position
This role will require Neuroscience experience in Global Regulatory Affairs and candidates with that specific experience will be prioritized. 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.
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.
Responsibilities
- 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.
Benefits
- Medical, pharmacy, dental, and vision care.
- BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- 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.
- flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
- 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
- unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
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What This Job Offers
Job Type
Full-time
Career Level
Director
