This 2-year Fellowship provides the opportunity to establish a broad understanding of Global Regulatory Strategy and its role in the drug development process. The Fellow will obtain direct experience and exposure to products at various stages of development and will learn important considerations for working with key regulatory agencies such as FDA and EMA. Optional rotation(s) in Global Pharmacovigilance & Epidemiology, Commercial Regulatory Affairs, Global Labeling, or Chemistry Manufacturing & Controls (CMC) will allow additional experience based on fellow interest and opportunities. During this program, the fellow will:
Participate in the development of global regulatory strategies supporting development, approval, and maintenance of drugs and biologics
Contribute to identification and assessment of regulatory risks and their mitigation
Participate in planning and preparing Health Authority (HA) interactions and assessing impact of HA feedback on an asset’s development plan
Contribute to responses to Health Authority Inquiries
Draft submission documents
Work with matrix team members (R&D and Non-R&D) to identify solutions that meet regulatory requirements as well as commercial objectives
Work with Global Policy team on reviewing special topics
Becca Shin, PharmD, MBAc
Ernest Mario School of Pharmacy
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.
The School has a historic and profound commitment to public service – to pharmacists, the pharmaceutical industry, the health care community, government agencies, and the citizens of New Jersey.