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.
Work Arrangement
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role.
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.
For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations / adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation / adjustment prior to accepting a job offer. If you require reasonable accommodations / adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to.
Qualifications
* 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.
EEO Statement
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Salary
Cambridge Crossing: $258,680 - $313,460
Princeton - NJ - US: $226,750 - $274,763
Company
Bristol Myers Squibb – The Global Pharmaceutical Company.
#J-18808-Ljbffr