Senior Manager, Commercial Regulatory Affairs - Advertising & Promotion

Primary responsibility: Provide expert and strategic regulatory advice and risk assessment on promotional issues, with management guidance, to ensure BMS implements product promotion consistent with BMS policies, PhRMA guidelines, 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 (as assigned) for marketed products.
- Assure full regulatory compliance of promotions with approved labeling and FDA guidance.
- Maintain up-to-date knowledge of federal and state laws/policies related to pharmaceutical advertising and promotion.
- Build strong relationships with internal customers (Commercial, Legal, Medical).
- Develop relationships with APLB.
- Prepare communications with guidance for APLB concerning Subpart E and advisory submissions.
- Ensure timely and accurate submission of promotional materials to APLB on Form 2253.
- Participate in review of product labeling submissions.
- Work with management to ensure changes in USPI are reflected in current promotions and advertising.
- Other duties/special projects as assigned.

Qualifications (Minimum Requirements):
- Bachelor’s degree required; life science area of study or advanced degree preferred (MS, PhD, PharmD, JD).
- 5+ years broad, hands-on related pharmaceutical experience and FDA regulatory experience; at least 1 year regulatory promotional review experience.
- Experience providing strategic direction to interdisciplinary teams on promotional materials for marketed products; strong interest in FDA advertising and promotional practice regulations.
- Detail- and deadline-oriented; well organized.
- Excellent verbal and written communication skills.
- Good interpersonal skills; ability to interact with staff at all levels.