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Senior Director, Global Regulatory Lead Neuroscience

Bristol-Myers Squibb

Healthcare Jobs

Senior Director, Global Regulatory Lead Neuroscience

full-timePosted: Nov 12, 2025

Job Description

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. 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. 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. 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. 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. Sr Director, Global Regulatory Strategy, Neuroscience 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. 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.

About the Role/Company

  • Bristol Myers Squibb (BMS) is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines for patients with serious diseases

Key Responsibilities

  • Develop global therapeutic regulatory strategies and operational plans for investigational and marketed products
  • Provide strategic and operational advice to development and commercialization teams
  • Evaluate emerging regulations and changing regulatory landscape for impact
  • Serve as the primary global point person for assigned projects
  • Work with regulatory product managers and operations group for preparation, production, and submission of health authority documents
  • Collaborate with regional international staff for diverse health authority submissions
  • Review and provide counsel on product development plans
  • Assemble global regulatory plans for identified projects/products
  • Influence and impart broad expertise regarding US and international regulatory environment
  • Serve as the primary interface with health authorities on assigned projects
  • Identify issues or projects that will impact BMS, regulatory affairs, or projects and provide strategies for dealing with them
  • Support due diligence and business development assessments
  • Act as a regulatory representative on various company-wide projects and initiatives
  • Be a key member of the GRSP Extended Leadership Team to ensure development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area

Required Qualifications

  • Advanced degree in scientific discipline (MD, PhD, or PharmD preferred)
  • -12 years of pharmaceutical industry experience
  • -8 years of experience in regulatory affairs
  • 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

Preferred Qualifications

  • Experience in neurology, neuromuscular diseases, or neuropsychiatry drug development
  • Global experience with a command of US experience and EU background

Skills Required

  • Inter-dependent partnering skills
  • Team-oriented approach
  • Ability to influence outcomes
  • Sensitivity and experience with non-domestic organizations/cross-cultural environments
  • Excellent organizational skills
  • Excellent communication skills
  • Excellent time management skills
  • Ability to manage multiple ongoing projects simultaneously
  • Ability to innovate, analyze, and solve critical/complex business problems

Locations

  • Princeton NJ, United States
  • Boudry, Switzerland
  • Uxbridge, GB
  • Cambridge Crossing MA, United States

Salary

Estimated Salary Rangemedium confidence

250,000 - 400,000 USD / yearly

Source: ai estimated

* This is an estimated range based on market data and may vary based on experience and qualifications.

Skills Required

  • Inter-dependent partnering skillsintermediate
  • Team-oriented approachintermediate
  • Ability to influence outcomesintermediate
  • Sensitivity and experience with non-domestic organizations/cross-cultural environmentsintermediate
  • Excellent organizational skillsintermediate
  • Excellent communication skillsintermediate
  • Excellent time management skillsintermediate
  • Ability to manage multiple ongoing projects simultaneouslyintermediate
  • Ability to innovate, analyze, and solve critical/complex business problemsintermediate

Required Qualifications

  • Advanced degree in scientific discipline (MD, PhD, or PharmD preferred) (experience)
  • -12 years of pharmaceutical industry experience (experience)
  • -8 years of experience in regulatory affairs (experience)
  • Thorough knowledge of the drug research, development, and commercialization process (experience)
  • Demonstrated expertise in one or more key areas: Drug Development, CMC, Pharmtox, Biopharmaceutics, Clinical, or Promotional (experience)

Preferred Qualifications

  • Experience in neurology, neuromuscular diseases, or neuropsychiatry drug development (experience)
  • Global experience with a command of US experience and EU background (experience)

Responsibilities

  • Develop global therapeutic regulatory strategies and operational plans for investigational and marketed products
  • Provide strategic and operational advice to development and commercialization teams
  • Evaluate emerging regulations and changing regulatory landscape for impact
  • Serve as the primary global point person for assigned projects
  • Work with regulatory product managers and operations group for preparation, production, and submission of health authority documents
  • Collaborate with regional international staff for diverse health authority submissions
  • Review and provide counsel on product development plans
  • Assemble global regulatory plans for identified projects/products
  • Influence and impart broad expertise regarding US and international regulatory environment
  • Serve as the primary interface with health authorities on assigned projects
  • Identify issues or projects that will impact BMS, regulatory affairs, or projects and provide strategies for dealing with them
  • Support due diligence and business development assessments
  • Act as a regulatory representative on various company-wide projects and initiatives
  • Be a key member of the GRSP Extended Leadership Team to ensure development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area

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Bristol-Myers Squibb logo

Senior Director, Global Regulatory Lead Neuroscience

Bristol-Myers Squibb

Healthcare Jobs

Senior Director, Global Regulatory Lead Neuroscience

full-timePosted: Nov 12, 2025

Job Description

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. 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. 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. 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. 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. Sr Director, Global Regulatory Strategy, Neuroscience 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. 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.

About the Role/Company

  • Bristol Myers Squibb (BMS) is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines for patients with serious diseases

Key Responsibilities

  • Develop global therapeutic regulatory strategies and operational plans for investigational and marketed products
  • Provide strategic and operational advice to development and commercialization teams
  • Evaluate emerging regulations and changing regulatory landscape for impact
  • Serve as the primary global point person for assigned projects
  • Work with regulatory product managers and operations group for preparation, production, and submission of health authority documents
  • Collaborate with regional international staff for diverse health authority submissions
  • Review and provide counsel on product development plans
  • Assemble global regulatory plans for identified projects/products
  • Influence and impart broad expertise regarding US and international regulatory environment
  • Serve as the primary interface with health authorities on assigned projects
  • Identify issues or projects that will impact BMS, regulatory affairs, or projects and provide strategies for dealing with them
  • Support due diligence and business development assessments
  • Act as a regulatory representative on various company-wide projects and initiatives
  • Be a key member of the GRSP Extended Leadership Team to ensure development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area

Required Qualifications

  • Advanced degree in scientific discipline (MD, PhD, or PharmD preferred)
  • -12 years of pharmaceutical industry experience
  • -8 years of experience in regulatory affairs
  • 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

Preferred Qualifications

  • Experience in neurology, neuromuscular diseases, or neuropsychiatry drug development
  • Global experience with a command of US experience and EU background

Skills Required

  • Inter-dependent partnering skills
  • Team-oriented approach
  • Ability to influence outcomes
  • Sensitivity and experience with non-domestic organizations/cross-cultural environments
  • Excellent organizational skills
  • Excellent communication skills
  • Excellent time management skills
  • Ability to manage multiple ongoing projects simultaneously
  • Ability to innovate, analyze, and solve critical/complex business problems

Locations

  • Princeton NJ, United States
  • Boudry, Switzerland
  • Uxbridge, GB
  • Cambridge Crossing MA, United States

Salary

Estimated Salary Rangemedium confidence

250,000 - 400,000 USD / yearly

Source: ai estimated

* This is an estimated range based on market data and may vary based on experience and qualifications.

Skills Required

  • Inter-dependent partnering skillsintermediate
  • Team-oriented approachintermediate
  • Ability to influence outcomesintermediate
  • Sensitivity and experience with non-domestic organizations/cross-cultural environmentsintermediate
  • Excellent organizational skillsintermediate
  • Excellent communication skillsintermediate
  • Excellent time management skillsintermediate
  • Ability to manage multiple ongoing projects simultaneouslyintermediate
  • Ability to innovate, analyze, and solve critical/complex business problemsintermediate

Required Qualifications

  • Advanced degree in scientific discipline (MD, PhD, or PharmD preferred) (experience)
  • -12 years of pharmaceutical industry experience (experience)
  • -8 years of experience in regulatory affairs (experience)
  • Thorough knowledge of the drug research, development, and commercialization process (experience)
  • Demonstrated expertise in one or more key areas: Drug Development, CMC, Pharmtox, Biopharmaceutics, Clinical, or Promotional (experience)

Preferred Qualifications

  • Experience in neurology, neuromuscular diseases, or neuropsychiatry drug development (experience)
  • Global experience with a command of US experience and EU background (experience)

Responsibilities

  • Develop global therapeutic regulatory strategies and operational plans for investigational and marketed products
  • Provide strategic and operational advice to development and commercialization teams
  • Evaluate emerging regulations and changing regulatory landscape for impact
  • Serve as the primary global point person for assigned projects
  • Work with regulatory product managers and operations group for preparation, production, and submission of health authority documents
  • Collaborate with regional international staff for diverse health authority submissions
  • Review and provide counsel on product development plans
  • Assemble global regulatory plans for identified projects/products
  • Influence and impart broad expertise regarding US and international regulatory environment
  • Serve as the primary interface with health authorities on assigned projects
  • Identify issues or projects that will impact BMS, regulatory affairs, or projects and provide strategies for dealing with them
  • Support due diligence and business development assessments
  • Act as a regulatory representative on various company-wide projects and initiatives
  • Be a key member of the GRSP Extended Leadership Team to ensure development, implementation, and alignment of regulatory strategies across projects and the Neuroscience therapeutic area

Target Your Resume for "Senior Director, Global Regulatory Lead Neuroscience" , Bristol-Myers Squibb

Get personalized recommendations to optimize your resume specifically for Senior Director, Global Regulatory Lead Neuroscience. Takes only 15 seconds!

AI-powered keyword optimization
Skills matching & gap analysis
Experience alignment suggestions

Check Your ATS Score for "Senior Director, Global Regulatory Lead Neuroscience" , Bristol-Myers Squibb

Find out how well your resume matches this job's requirements. Get comprehensive analysis including ATS compatibility, keyword matching, skill gaps, and personalized recommendations.

ATS compatibility check
Keyword optimization analysis
Skill matching & gap identification
Format & readability score

Tags & Categories

PharmaceuticalPharmaceuticalHealthcare

Answer 10 quick questions to check your fit for Senior Director, Global Regulatory Lead Neuroscience @ Bristol-Myers Squibb.

Quiz Challenge
10 Questions
~2 Minutes
Instant Score

Related Books and Jobs

No related jobs found at the moment.