Senior Manager, Commercial Regulatory Affairs - Advertising & Promotion

Primary responsibility: Provide expert, strategic regulatory advice and risk assessment on promotional issues to ensure BMS product promotion aligns with BMS policies, PhRMA/FTC guidelines, and applicable FDA regulations and guidance.

Major Responsibilities and Accountabilities:
- Provide regulatory advice and risk assessment on advertising/promotional materials, sales training materials, and external communications.
- Ensure full regulatory compliance of promotions with approved labeling and FDA guidance.
- Maintain up-to-date knowledge of federal/state advertising and pharmaceutical promotion laws and policies.
- Partner with internal stakeholders (Commercial, Legal, Medical); develop relationships with APLB.
- Prepare APLB communications on Subpart E and advisory submissions.
- Ensure timely/accurate submission of promotional materials to APLB on Form 2253.
- Participate in review of product labeling submissions.
- Ensure USPI changes are reflected in current promotions and advertising.
- Other duties/special projects as assigned.

Qualifications:
- Bachelor’s required; life science preferred; MS/PhD/PharmD/JD preferred.
- 5+ years broad hands-on pharmaceutical and FDA regulatory experience; 1+ year regulatory promotional review experience.
- Experience providing strategic direction to interdisciplinary teams on promotional materials; strong interest/knowledge of FDA advertising and promotional practice regulations.
- Detail- and deadline-oriented; well organized.
- Excellent verbal/written communication; strong interpersonal skills.

Benefits (high level):
- Health coverage (medical/pharmacy/dental/vision), wellbeing support, 401(k), life/disability and other financial protection; paid time off.

Application instruction: If the role intrigues you but doesn’t perfectly match your resume, apply anyway.