Manager, Commercial Regulatory Affairs


(BMS) Bristol-Myers Squibb

2020-08-05 04:51:31

Job location Trenton, New Jersey, United States

Job type: fulltime

Job industry: Government & Defence

Job description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science.In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.The primary responsibility of a 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 guidances.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 assignedQualifications: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.Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.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.

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