Senior Manager, Commercial Regulatory Affairs - Advertising & Promotion

Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.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 with guidance from management to ensure that BMS implements product promotion consistent with BMS policies, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidance’s.Major Responsibilities and Accountabilities: 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 assignedQualificationsMinimum RequirementsMinimum education of a bachelor's degree is required. Life science area of study or advanced degree preferred (MS, PhD, PharmD, or JD).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.#LI-HybridIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Compensation Overview:Madison - Giralda - NJ - US: $126,110 - $152,811 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:Health Coverage: Medical, pharmacy, dental, and vision care.Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).Financial Well-being and Protection: 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, and survivor support.​Work-life benefits include:Paid Time OffUS Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidaysBased on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective