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Bristol Myers Squibb

Senior Director, Global Regulatory Lead – Neuroscience

Bristol Myers Squibb

. Serve as a key member of the GRSP Extended Leadership Team .

Posted 10/20/2026full-timeUnited StatesSenior💰 $226,750 - $313,460 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates extensive expertise in regulatory affairs within the pharmaceutical industry, particularly in drug development and commercialization processes. Possesses strong strategic and operational capabilities to navigate complex regulatory landscapes and collaborate effectively with cross-functional teams.

Highest-signal resume keywords
Regulatory Affairs ExpertiseDrug Development KnowledgeGlobal Regulatory StrategyNeurology Drug Development ExperienceCross-Cultural Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory Strategy DevelopmentHealth Authority SubmissionsDrug Research and DevelopmentCMC KnowledgePharmtox ExpertiseBiopharmaceutics UnderstandingClinical DevelopmentPromotional ReviewOperational PlanningRegulatory Compliance
Soft Skills
Inter-Dependent Partnering SkillsInfluencing OutcomesOrganizational SkillsCommunication SkillsTime Management
Certifications & Qualifications
MDPhDPharmD
Industry Keywords
Pharmaceutical IndustryNeuroscience Therapeutic AreaNeuromuscular DiseasesNeuropsychiatryGlobal ExperienceU.S. Regulatory ExperienceEU Regulatory BackgroundEmerging RegulationsHealth AuthoritiesCross-Cultural Environments

About the role

Key responsibilities & impact
  • Serve as a key member of the GRSP Extended Leadership Team
  • Ensure development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area
  • Act as regulatory representative on company-wide projects and initiatives
  • Support due diligence and business development assessments
  • Work with regional regulatory staff as Global Regulatory Lead and U.S. Regional Regulatory Lead on assigned development assets and marketed products
  • Develop global therapeutic regulatory strategies and operational plans
  • Review and provide counsel on product development plans
  • Assemble global regulatory plans for identified projects and products
  • Provide strategic and operational advice to development and commercialization teams
  • Serve as the primary global point person for assigned projects
  • Evaluate emerging regulations and changes in the regulatory landscape
  • Serve as the primary interface with health authorities
  • Identify issues affecting BMS, regulatory affairs, or projects and develop strategies to address them
  • Work with regulatory product managers and regulatory operations on preparation, production, and submission of health authority documents
  • Coordinate with regional international staff on health authority submissions

Requirements

What you’ll need
  • Advanced degree in a scientific discipline
  • MD, PhD or PharmD preferred
  • Experience in neurology, neuromuscular diseases or neuropsychiatry drug development strongly preferred
  • 8-12 years of pharmaceutical industry experience
  • 6-8 years in regulatory affairs
  • Global experience strongly preferred, with command of U.S. experience and EU background desired
  • Thorough knowledge of the drug research, development, and commercialization process
  • Demonstrated expertise in one or more key areas: Drug Development, CMC, Pharmtox, Biopharmaceutics, Clinical, or Promotional
  • Inter-dependent partnering skills and ability to influence outcomes
  • Experience with non-domestic organizations and cross-cultural environments
  • Excellent organizational, communication and time management skills
  • Ability to innovate, analyze and solve critical/complex business problems

Benefits

Comp & perks
  • Comprehensive benefit plans including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life and disability insurance
  • Flexible Time Off (FTO) for U.S.-based exempt employees
  • 11 paid company holidays each year
  • 160 hours of paid vacation annually for eligible new hires
  • 3 optional holidays for eligible employees
  • Paid sick leave
  • Up to two paid volunteer days per year
  • Summer hours flexibility
  • Leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
  • Annual Global Shutdown between Christmas Day and New Year's Day