Senior Director, Global Regulatory Lead Neuroscience

About the role

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.

Supports due diligence and business development assessments.

Works with regional regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead on assigned development assets and marketed products:

• Develops global therapeutic regulatory strategies and operational plans for identified investigational and marketed products.
• Reviews/provides counsel on product development plans.
• Assembles the global regulatory plans for identified projects/products.
• Influences and imparts broad expertise regarding US and international regulatory environment.
• Serves 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.
• Serves as the primary interface with health authorities on assigned projects.
• Identifies issues or 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.

Responsibilities

• 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 expertise in one or more key areas – Drug Development/CMC/Pharmtox/ Biopharmaceutics/Clinical/Promotional.
• Interdependent 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.

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 expertise in one or more key areas – Drug Development/CMC/Pharmtox/ Biopharmaceutics/Clinical/Promotional.
• Interdependent 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.

Skills

• 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 expertise in one or more key areas – Drug Development/CMC/Pharmtox/ Biopharmaceutics/Clinical/Promotional.
• Interdependent 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

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Health Coverage: Medical, pharmacy, dental, and vision care.

Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).

Financial Well-being and Protection: 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.

Work-life Benefits Include Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.

Based on eligibility*, additional time off for employees may include 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.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager.

Candidates Covered Under a Collective Bargaining Agreement Should Consult That Document To Determine If They Are Eligible.

Contractors, Leased Workers And Other Service Providers Are Not Eligible To Participate In The Program.

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