Strategic Leader, US Commercial Regulatory Affairs

Bristol-Myers Squibb; Princeton (NJ); On-site; USD 173,350 - 210,058; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k) and Insurance

Job summary

Bristol Myers Squibb in Princeton, NJ is seeking an Associate Director of US Commercial Regulatory Affairs to apply complex regulatory advice and risk assessment for promotional campaigns and materials. You will ensure compliance with FDA regulations, PhRMA guidelines, and FTC guidance while coordinating with Commercial, Medical, Public Affairs, and Legal teams.

The role involves leading strategic submissions, training, and monitoring evolving regulatory requirements to deliver compliant,

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
• Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products
• Ability to propose regulatory strategies for advertising and promotion campaigns
• Proven aptitude to analyze and interpret efficacy and safety data
• Experience communicating and negotiating with OPDP
• Organizational skills with attention to detail; ability to influence cross-functional teams
• Excellent verbal, communication, and presentation skills
• Excellent interpersonal skills, flexibility, adaptable to changing environment and cross-functional communication

Responsibilities

• Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams and other internal groups on all promotional materials
• Provides solution-oriented and innovative advice to meet company objectives
• Provide strategic advice for development of Office Of Prescription Drug Promotion submissions
• Ensure full regulatory compliance of all promotions with approved labeling and FDA guidances
• Lead training for Commercial teams on sub part e, 2253 regulations and FDA regulations on advertising
• Develop and maintain relationships with internal customers including Commercial, Medical, Public Affairs, Legal and Compliance
• Integrate compliance considerations into risk assessment with Legal/Compliance
• Provide advice on development of draft product labeling to ensure commercially viable US labeling
• Contribute to process improvement and alignment with BMS guiding principles
• Engage with colleagues to support roles and development
• Provide direct management to individuals depending on assignment

Skills

Excellent verbal communication

Presentation skills

Interpersonal skills

Organizational skills

Attention to detail

Education

BS required; advanced degree preferred (MS, PhD, PharmD, JD)

Job description

Bristol Myers Squibb in Princeton, NJ is seeking an Associate Director of US Commercial Regulatory Affairs to apply complex regulatory advice and risk assessment for promotional campaigns and materials. You will ensure compliance with FDA regulations, PhRMA guidelines, and FTC guidance while coordinating with Commercial, Medical, Public Affairs, and Legal teams.

The role involves leading strategic submissions, training, and monitoring evolving regulatory requirements to deliver compliant,