Sr. Manager, Commercial Regulatory Affairs

Working with Us
Challenging. 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.

 

Responsibilities include:

• 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 OPDP.
• Prepare communications with guidance for OPDP concerning sub part e and advisory submissions.
• Ensure timely and accurate submission of promotional materials to OPDP on Form 2253.
• Participate in review of product labeling submissions.
• Works with management to ensure that changes in US PI are reflected in current promotions and advertising.
• Handle other duties and/or special projects as assigned

Qualifications:

• Bachelors Life Science degree required; advanced degree preferred (MS, PhD, PharmD, or JD).
• Candidate should have a minimum of 1-2 years Regulatory promotional review experience.
• Candidate should have 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). 
• Broad “hands on” related pharmaceutical experience (prefer 5 years pharmaceutical industry experience) and actual FDA regulatory experience.
• Detail & deadline oriented; well organized.
• Excellent verbal and written communication skills.
• Good interpersonal skills; ability to interact with staff on all levels.

If 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 Princeton - 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