The US Commercial Regulatory Affairs group at Bristol-Myers Squibb provides strategic regulatory
guidance within the company on the Food and Drug Administration (FDA) advertising and
promotion regulations to support good business practices. The regulatory advice is provided to the
marketing organization to ensure the highest level of ethics and integrity in the promotion of Bristol-
Myers Squibb products. The group collaborates with a variety of functions including Marketing,
Medical Affairs, Legal, Global Labeling, Managed Markets, Global Regulatory, Safety, and
Biometrics. The Fellow will be assigned to a primary therapeutic area. Key activities and learnings
Gaining an understanding of and ensuring consistency between key federal regulations and
Bristol-Myers Squibb policies
Analyzing the impact of FDA Office of Prescription Drug Promotion (OPDP) enforcement actions
and assessing the regulatory implication to commercial activities
Assisting in the regulatory review of proposed promotional materials and programs created by
Marketing, Sales, or Corporate Affairs and submissions to OPDP
Collaborating with matrix team members to advise on the development of marketing campaigns
that meet regulatory requirements as well as commercial objectives
Divisha Dixit, PharmD
o Manager, US Commercial Regulatory Affairs
Christine Novak, PharmD
o Associate Director, US Commercial Regulatory Affairs
Please consider attending Fellowship Information and Network Day here at Rutgers Ernest Mario School of Pharmacy on November 22nd from 3:30 PM – 8:00 PM so we can visit with you about your interests. For additional information please visit our website: http://pharmafellows.rutgers.edu/applicants/fid.php.
We do not pre-schedule interviews for Midyear, so please do not request an interview via this website. Your emails will not be reviewed.
We will be scheduling interviews starting at 10 AM on December 7th. Prior to scheduling an interview you will need to view the Fellowship information video
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The Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey, is dedicated to excellence in healthcare and biomedical education, innovative and visionary research and scholarship in the pharmaceutical sciences, exemplary clinical practice, and outreach and community services that address the needs of the citizens of New Jersey and society at large.
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