Bristol Myers Squibb
Associate Director, US Commercial Regulatory Affairs - Advertising and Promotion
Bristol Myers Squibb, Princeton, New Jersey, us, 08543
Associate Director, US Commercial Regulatory Affairs - Advertising and Promotion (Hybrid)
Join to apply for the
Associate Director, US Commercial Regulatory Affairs - Advertising and Promotion (Hybrid)
role at
Bristol Myers Squibb .
Challenging. Meaningful. Life‑changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high‑achieving teams. Take your career farther than you thought possible.
Description : The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company’s objectives are met. The individual will ensure materials are consistent with BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances.
Responsibilities
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
Qualifications
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.
Compensation Overview Madison – Giralda – NJ – US: $173,350 – $210,058
Princeton – NJ – US: $173,350 – $210,058
The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job‑related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit
https://careers.bms.com/life-at-bms/ .
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care; wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP); financial well‑being resources and a 401(k); financial protection benefits such as short‑ and long‑term disability, life insurance, supplemental health insurance, business travel protection and survivor support; work‑life programs including 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; parental, caregiver, bereavement, and military leave; family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources; other perks like tuition reimbursement and a recognition program.
Equal Employment Opportunity and Data Protection 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at
https://careers.bms.com/fraud-protection . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
#J-18808-Ljbffr
Associate Director, US Commercial Regulatory Affairs - Advertising and Promotion (Hybrid)
role at
Bristol Myers Squibb .
Challenging. Meaningful. Life‑changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high‑achieving teams. Take your career farther than you thought possible.
Description : The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company’s objectives are met. The individual will ensure materials are consistent with BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances.
Responsibilities
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
Qualifications
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.
Compensation Overview Madison – Giralda – NJ – US: $173,350 – $210,058
Princeton – NJ – US: $173,350 – $210,058
The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job‑related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit
https://careers.bms.com/life-at-bms/ .
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care; wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP); financial well‑being resources and a 401(k); financial protection benefits such as short‑ and long‑term disability, life insurance, supplemental health insurance, business travel protection and survivor support; work‑life programs including 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; parental, caregiver, bereavement, and military leave; family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources; other perks like tuition reimbursement and a recognition program.
Equal Employment Opportunity and Data Protection 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at
https://careers.bms.com/fraud-protection . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
#J-18808-Ljbffr