Senior Manager, Commercial Regulatory Affairs - Advertising & Promotion

Bristol Myers Squibb•Madison, NJ

18h•Hybrid

About The Position

Working at Bristol Myers Squibb offers challenging, meaningful, and life-changing work, with opportunities for growth and development alongside high-achieving teams. The company values balance and flexibility, providing competitive benefits and programs to support employees' personal and professional goals. The primary responsibility of a Senior Manager in Commercial Regulatory Affairs is to provide expert and strategic regulatory advice and risk assessment on promotional issues, ensuring that product promotion aligns with BMS policies, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidance.

Requirements

Minimum education of a bachelor's degree is required.
Minimum of five (5) years of broad “hands on” related pharmaceutical experience and FDA regulatory experience is required.
Minimum of at least one (1) year of regulatory promotional review experience is required.
Experience providing strategic direction to interdisciplinary teams on promotional materials activities for marketed products and strong interest in FDA advertising and promotional practice regulations including guidance(s).
Detail & deadline oriented; well organized.
Excellent verbal and written communication skills.
Good interpersonal skills; ability to interact with staff on all levels.

Nice To Haves

Life science area of study or advanced degree preferred (MS, PhD, PharmD, or JD)

Responsibilities

Provide regulatory advice and risk assessment on concepts and final advertising/ promotional materials, sales training materials, and external communications for marketed products, as assigned.
Assure full regulatory compliance of all promotions with approved labeling and FDA guidance.
Maintain up-to-date knowledge of laws, regulations and policies enforced by the Federal and State governments as they relate to advertising and promotion of pharmaceuticals.
Build a strong relationship with internal customers, including Commercial, Legal and Medical.
Begin to 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.
Works with management to ensure that changes in USPI are reflected in current promotions and advertising.
Handle other duties and/or special projects as assigned

Benefits

Medical care
Pharmacy care
Dental care
Vision care
BMS Well-Being Account
BMS Living Life Better programs
Employee Assistance Programs (EAP)
401(k) plan
Short- and long-term disability
Life insurance
Accident insurance
Supplemental health insurance
Business travel protection
Personal liability protection
Identity theft benefit
Legal support
Survivor support
Flexible time off (unlimited, with manager approval for US Exempt Employees)
11 paid national holidays (for US Exempt Employees, Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees)
160 hours annual paid vacation for new hires (Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees)
3 optional holidays (Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees)
Unlimited paid sick time (based on eligibility)
Up to 2 paid volunteer days per year (based on eligibility)
Summer hours flexibility (based on eligibility)
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
Annual Global Shutdown between Christmas and New Years Day
Additional incentive cash opportunities
Stock opportunities