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Bristol-Myers Squibb logo

Associate Director, US Commercial Regulatory Affairs – Advertising and Promotion (Hybrid)

Bristol-Myers Squibb

Associate Director, US Commercial Regulatory Affairs – Advertising and Promotion (Hybrid)

Bristol-Myers Squibb logo

Bristol-Myers Squibb

full-time

Posted: November 25, 2025

Number of Vacancies: 1

Job Description

Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area Provides solution-oriented and innovative advice to meet the company's objectives and goals Provide strategic advice for the development of Advertising and Promotional Labeling Branch (APLB) and Office Of Prescription Drug Promotion (OPDP) advisory submissions and subpart E and H submissions Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidances Ensure regulatory compliance with subpart E/H and 2253 regulations Lead training for Commercial teams on subpart E/H, 2253 regulations and FDA regulations on advertising and promotion Ensure monitoring and maintenance of knowledge of the evolving regulatory landscape to provide innovative solutions and advice Pursues and understands diverse perspectives inside and outside BMS to provide risk assessment and mitigation strategies Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Public Affairs, Legal and Compliance Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues Provide advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based Provide input on process improvement and BMS guiding principles as needed Engages with colleagues within the department to help support them in their roles and development Provide direct management to individuals depending on assignment Proactively seeks opportunities to learn and develop leadership skills Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities BS required; advanced degree preferred (MS, PhD, PharmD, JD) Minimum of 3-5 years Regulatory promotional review or related 5 to 8 years pharmaceutical experience (e.g., Medical promotional review) Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s) Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns Proven aptitude to analyze and interpret efficacy and safety data Experience communicating and negotiating with OPDP/APLB Organizational skills and ability to pay attention to details. Demonstrated ability to negotiate and influence others to help build team collaboration Excellent verbal, communication, and presentation skills Excellent interpersonal skills, flexibility, adaptable to a changing environment and adeptness to communicate effectively with cross functional teams and with business partners across the company.

Key Responsibilities

  • Provide regulatory advice, risk assessment, and mitigation strategies to various internal groups on promotional materials
  • Offer solution-oriented and innovative advice to meet company objectives and goals
  • Provide strategic advice for the development of APLB and OPDP advisory submissions and subpart E and H submissions
  • Ensure full regulatory compliance of all promotions with approved labeling and/or FDA guidances
  • Ensure regulatory compliance with subpart E/H and 2253 regulations
  • Lead training for Commercial teams on subpart E/H, 2253 regulations, and FDA regulations on advertising and promotion
  • Monitor and maintain knowledge of the evolving regulatory landscape to provide innovative solutions and advice
  • Pursue and understand diverse perspectives to provide risk assessment and mitigation strategies
  • Develop and maintain strong working relationships with internal customers including Commercial, Medical, Public Affairs, Legal, and Compliance
  • Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues
  • Provide advice and guidance on the development of draft product labeling to ensure commercially viable US labeling
  • Provide input on process improvement and BMS guiding principles as needed
  • Engage with colleagues within the department to support their roles and development
  • Provide direct management to individuals depending on assignment
  • Proactively seek opportunities to learn and develop leadership skills

Required Qualifications

  • Bachelor's degree required
  • -5 years of experience in Regulatory promotional review or related field
  • to 8 years of pharmaceutical experience, such as in Medical promotional review

Preferred Qualifications

  • Advanced degree preferred (MS, PhD, PharmD, JD)

Skills Required

  • Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products
  • Strong interest in FDA advertising and promotion regulations including guidance(s)
  • Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns
  • Proven aptitude to analyze and interpret efficacy and safety data
  • Experience communicating and negotiating with OPDP/APLB
  • Organizational skills and attention to detail
  • Demonstrated ability to negotiate and influence others to build team collaboration
  • Excellent verbal, communication, and presentation skills
  • Excellent interpersonal skills
  • Flexibility and adaptability to a changing environment
  • Adeptness to communicate effectively with cross-functional teams and business partners across the company

Benefits & Perks

  • Paid national holidays and optional holidays
  • Global Shutdown Days between Christmas and New Year's holiday
  • Up to 120 hours of paid vacation
  • Up to two (2) paid days to volunteer
  • Sick time off
  • Summer hours flexibility
  • Programs supporting people with disabilities

Locations

  • Madison Giralda NJ, United States
  • Princeton NJ, United States

Salary

Salary not disclosed

Estimated Salary Rangemedium confidence

150,000 - 220,000 USD / yearly

Source: ai estimated

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

Skills Required

  • Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed productsintermediate
  • Strong interest in FDA advertising and promotion regulations including guidance(s)intermediate
  • Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaignsintermediate
  • Proven aptitude to analyze and interpret efficacy and safety dataintermediate
  • Experience communicating and negotiating with OPDP/APLBintermediate
  • Organizational skills and attention to detailintermediate
  • Demonstrated ability to negotiate and influence others to build team collaborationintermediate
  • Excellent verbal, communication, and presentation skillsintermediate
  • Excellent interpersonal skillsintermediate
  • Flexibility and adaptability to a changing environmentintermediate
  • Adeptness to communicate effectively with cross-functional teams and business partners across the companyintermediate

Required Qualifications

  • Bachelor's degree required (experience)
  • -5 years of experience in Regulatory promotional review or related field (experience)
  • to 8 years of pharmaceutical experience, such as in Medical promotional review (experience)

Preferred Qualifications

  • Advanced degree preferred (MS, PhD, PharmD, JD) (experience)

Responsibilities

  • Provide regulatory advice, risk assessment, and mitigation strategies to various internal groups on promotional materials
  • Offer solution-oriented and innovative advice to meet company objectives and goals
  • Provide strategic advice for the development of APLB and OPDP advisory submissions and subpart E and H submissions
  • Ensure full regulatory compliance of all promotions with approved labeling and/or FDA guidances
  • Ensure regulatory compliance with subpart E/H and 2253 regulations
  • Lead training for Commercial teams on subpart E/H, 2253 regulations, and FDA regulations on advertising and promotion
  • Monitor and maintain knowledge of the evolving regulatory landscape to provide innovative solutions and advice
  • Pursue and understand diverse perspectives to provide risk assessment and mitigation strategies
  • Develop and maintain strong working relationships with internal customers including Commercial, Medical, Public Affairs, Legal, and Compliance
  • Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues
  • Provide advice and guidance on the development of draft product labeling to ensure commercially viable US labeling
  • Provide input on process improvement and BMS guiding principles as needed
  • Engage with colleagues within the department to support their roles and development
  • Provide direct management to individuals depending on assignment
  • Proactively seek opportunities to learn and develop leadership skills

Benefits

  • general: Paid national holidays and optional holidays
  • general: Global Shutdown Days between Christmas and New Year's holiday
  • general: Up to 120 hours of paid vacation
  • general: Up to two (2) paid days to volunteer
  • general: Sick time off
  • general: Summer hours flexibility
  • general: Programs supporting people with disabilities

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Bristol-Myers Squibb logo

Associate Director, US Commercial Regulatory Affairs – Advertising and Promotion (Hybrid)

Bristol-Myers Squibb

Associate Director, US Commercial Regulatory Affairs – Advertising and Promotion (Hybrid)

Bristol-Myers Squibb logo

Bristol-Myers Squibb

full-time

Posted: November 25, 2025

Number of Vacancies: 1

Job Description

Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area Provides solution-oriented and innovative advice to meet the company's objectives and goals Provide strategic advice for the development of Advertising and Promotional Labeling Branch (APLB) and Office Of Prescription Drug Promotion (OPDP) advisory submissions and subpart E and H submissions Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidances Ensure regulatory compliance with subpart E/H and 2253 regulations Lead training for Commercial teams on subpart E/H, 2253 regulations and FDA regulations on advertising and promotion Ensure monitoring and maintenance of knowledge of the evolving regulatory landscape to provide innovative solutions and advice Pursues and understands diverse perspectives inside and outside BMS to provide risk assessment and mitigation strategies Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Public Affairs, Legal and Compliance Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues Provide advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based Provide input on process improvement and BMS guiding principles as needed Engages with colleagues within the department to help support them in their roles and development Provide direct management to individuals depending on assignment Proactively seeks opportunities to learn and develop leadership skills Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities BS required; advanced degree preferred (MS, PhD, PharmD, JD) Minimum of 3-5 years Regulatory promotional review or related 5 to 8 years pharmaceutical experience (e.g., Medical promotional review) Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s) Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns Proven aptitude to analyze and interpret efficacy and safety data Experience communicating and negotiating with OPDP/APLB Organizational skills and ability to pay attention to details. Demonstrated ability to negotiate and influence others to help build team collaboration Excellent verbal, communication, and presentation skills Excellent interpersonal skills, flexibility, adaptable to a changing environment and adeptness to communicate effectively with cross functional teams and with business partners across the company.

Key Responsibilities

  • Provide regulatory advice, risk assessment, and mitigation strategies to various internal groups on promotional materials
  • Offer solution-oriented and innovative advice to meet company objectives and goals
  • Provide strategic advice for the development of APLB and OPDP advisory submissions and subpart E and H submissions
  • Ensure full regulatory compliance of all promotions with approved labeling and/or FDA guidances
  • Ensure regulatory compliance with subpart E/H and 2253 regulations
  • Lead training for Commercial teams on subpart E/H, 2253 regulations, and FDA regulations on advertising and promotion
  • Monitor and maintain knowledge of the evolving regulatory landscape to provide innovative solutions and advice
  • Pursue and understand diverse perspectives to provide risk assessment and mitigation strategies
  • Develop and maintain strong working relationships with internal customers including Commercial, Medical, Public Affairs, Legal, and Compliance
  • Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues
  • Provide advice and guidance on the development of draft product labeling to ensure commercially viable US labeling
  • Provide input on process improvement and BMS guiding principles as needed
  • Engage with colleagues within the department to support their roles and development
  • Provide direct management to individuals depending on assignment
  • Proactively seek opportunities to learn and develop leadership skills

Required Qualifications

  • Bachelor's degree required
  • -5 years of experience in Regulatory promotional review or related field
  • to 8 years of pharmaceutical experience, such as in Medical promotional review

Preferred Qualifications

  • Advanced degree preferred (MS, PhD, PharmD, JD)

Skills Required

  • Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products
  • Strong interest in FDA advertising and promotion regulations including guidance(s)
  • Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns
  • Proven aptitude to analyze and interpret efficacy and safety data
  • Experience communicating and negotiating with OPDP/APLB
  • Organizational skills and attention to detail
  • Demonstrated ability to negotiate and influence others to build team collaboration
  • Excellent verbal, communication, and presentation skills
  • Excellent interpersonal skills
  • Flexibility and adaptability to a changing environment
  • Adeptness to communicate effectively with cross-functional teams and business partners across the company

Benefits & Perks

  • Paid national holidays and optional holidays
  • Global Shutdown Days between Christmas and New Year's holiday
  • Up to 120 hours of paid vacation
  • Up to two (2) paid days to volunteer
  • Sick time off
  • Summer hours flexibility
  • Programs supporting people with disabilities

Locations

  • Madison Giralda NJ, United States
  • Princeton NJ, United States

Salary

Salary not disclosed

Estimated Salary Rangemedium confidence

150,000 - 220,000 USD / yearly

Source: ai estimated

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

Skills Required

  • Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed productsintermediate
  • Strong interest in FDA advertising and promotion regulations including guidance(s)intermediate
  • Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaignsintermediate
  • Proven aptitude to analyze and interpret efficacy and safety dataintermediate
  • Experience communicating and negotiating with OPDP/APLBintermediate
  • Organizational skills and attention to detailintermediate
  • Demonstrated ability to negotiate and influence others to build team collaborationintermediate
  • Excellent verbal, communication, and presentation skillsintermediate
  • Excellent interpersonal skillsintermediate
  • Flexibility and adaptability to a changing environmentintermediate
  • Adeptness to communicate effectively with cross-functional teams and business partners across the companyintermediate

Required Qualifications

  • Bachelor's degree required (experience)
  • -5 years of experience in Regulatory promotional review or related field (experience)
  • to 8 years of pharmaceutical experience, such as in Medical promotional review (experience)

Preferred Qualifications

  • Advanced degree preferred (MS, PhD, PharmD, JD) (experience)

Responsibilities

  • Provide regulatory advice, risk assessment, and mitigation strategies to various internal groups on promotional materials
  • Offer solution-oriented and innovative advice to meet company objectives and goals
  • Provide strategic advice for the development of APLB and OPDP advisory submissions and subpart E and H submissions
  • Ensure full regulatory compliance of all promotions with approved labeling and/or FDA guidances
  • Ensure regulatory compliance with subpart E/H and 2253 regulations
  • Lead training for Commercial teams on subpart E/H, 2253 regulations, and FDA regulations on advertising and promotion
  • Monitor and maintain knowledge of the evolving regulatory landscape to provide innovative solutions and advice
  • Pursue and understand diverse perspectives to provide risk assessment and mitigation strategies
  • Develop and maintain strong working relationships with internal customers including Commercial, Medical, Public Affairs, Legal, and Compliance
  • Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues
  • Provide advice and guidance on the development of draft product labeling to ensure commercially viable US labeling
  • Provide input on process improvement and BMS guiding principles as needed
  • Engage with colleagues within the department to support their roles and development
  • Provide direct management to individuals depending on assignment
  • Proactively seek opportunities to learn and develop leadership skills

Benefits

  • general: Paid national holidays and optional holidays
  • general: Global Shutdown Days between Christmas and New Year's holiday
  • general: Up to 120 hours of paid vacation
  • general: Up to two (2) paid days to volunteer
  • general: Sick time off
  • general: Summer hours flexibility
  • general: Programs supporting people with disabilities

Target Your Resume for "Associate Director, US Commercial Regulatory Affairs – Advertising and Promotion (Hybrid)" , Bristol-Myers Squibb

Get personalized recommendations to optimize your resume specifically for Associate Director, US Commercial Regulatory Affairs – Advertising and Promotion (Hybrid). Takes only 15 seconds!

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

Check Your ATS Score for "Associate Director, US Commercial Regulatory Affairs – Advertising and Promotion (Hybrid)" , 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

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