Associate Director, Commercial Regulatory Affairs
Bristol Myers Squibb
August 22, 2026
Remote friendly (Princeton, NJ)
United States
Corporate Functions
Responsibilities:
- Provide regulatory advice, risk assessment, and mitigation strategies for Commercial, Medical Affairs, Public Affairs, Value Access & Payment, and other internal teams on promotional materials (concepts, disease awareness, institutional campaigns) for assigned products/therapeutic areas.
- Provide solution-oriented/innovative advice to meet company objectives.
- Develop strategic guidance for OPDP advisory submissions and subpart e submissions.
- Ensure promotional compliance with approved labeling and applicable FDA guidances; ensure compliance with subpart e and 2253 regulations.
- Lead training for Commercial teams on subpart e, 2253, and FDA advertising/promotion regulations.
- Monitor and maintain knowledge of the evolving regulatory landscape; provide innovative solutions.
- Partner with Legal/Compliance to integrate compliance considerations into risk assessments.
- Advise on draft US product labeling to support commercially viable labeling.
- Provide input on process improvement and guiding principles as needed; engage to support colleagues.
- Provide direct management as assigned; proactively develop leadership skills.
Qualifications:
- BS required; MS/PhD/PharmD/JD preferred.
- 3–5 years regulatory promotional review; or 5–8 years pharmaceutical experience (e.g., medical promotional review).
- Experience providing risk assessment for interdisciplinary promotional activities; strong interest in FDA advertising/promotion regulations.
- Ability to propose regulatory strategies for advertising/disease awareness/institutional campaigns.
- Ability to analyze efficacy and safety data.
- Experience communicating/negotiating with OPDP.
- Organizational/detail orientation; negotiation/influence and collaboration.
- Excellent verbal, communication, presentation, and interpersonal skills; adaptable for cross-functional teams.
Benefits (explicit): Health, wellbeing, and financial protection programs; 401(k), disability/life insurance; paid time off options (flexible time off for US exempt; or 160 hours annual vacation plus holidays for certain locations/roles).
Compensation (explicit): $173,350–$210,058 (Princeton, NJ, US).
- Provide regulatory advice, risk assessment, and mitigation strategies for Commercial, Medical Affairs, Public Affairs, Value Access & Payment, and other internal teams on promotional materials (concepts, disease awareness, institutional campaigns) for assigned products/therapeutic areas.
- Provide solution-oriented/innovative advice to meet company objectives.
- Develop strategic guidance for OPDP advisory submissions and subpart e submissions.
- Ensure promotional compliance with approved labeling and applicable FDA guidances; ensure compliance with subpart e and 2253 regulations.
- Lead training for Commercial teams on subpart e, 2253, and FDA advertising/promotion regulations.
- Monitor and maintain knowledge of the evolving regulatory landscape; provide innovative solutions.
- Partner with Legal/Compliance to integrate compliance considerations into risk assessments.
- Advise on draft US product labeling to support commercially viable labeling.
- Provide input on process improvement and guiding principles as needed; engage to support colleagues.
- Provide direct management as assigned; proactively develop leadership skills.
Qualifications:
- BS required; MS/PhD/PharmD/JD preferred.
- 3–5 years regulatory promotional review; or 5–8 years pharmaceutical experience (e.g., medical promotional review).
- Experience providing risk assessment for interdisciplinary promotional activities; strong interest in FDA advertising/promotion regulations.
- Ability to propose regulatory strategies for advertising/disease awareness/institutional campaigns.
- Ability to analyze efficacy and safety data.
- Experience communicating/negotiating with OPDP.
- Organizational/detail orientation; negotiation/influence and collaboration.
- Excellent verbal, communication, presentation, and interpersonal skills; adaptable for cross-functional teams.
Benefits (explicit): Health, wellbeing, and financial protection programs; 401(k), disability/life insurance; paid time off options (flexible time off for US exempt; or 160 hours annual vacation plus holidays for certain locations/roles).
Compensation (explicit): $173,350–$210,058 (Princeton, NJ, US).