The one-year Regulatory Affairs (RA) Fellowship is designed to provide a broad understanding of the various roles and responsibilities within Regulatory Affairs, including Strategy, Chemistry Manufacturing and Control, Advertising and Promotion, and Operations/Publishing. It also offers an opportunity to work on cross-functional projects, and gain insights into drug development processes, including the role of other departments such as Quality Assurance, Project Management, and Medical Writing.
The Fellowship will provide hands-on training, experience and mentorship, and offer the Fellow projects and responsibilities on Neurocrine development programs involving cross-functional partners. The fellow will play a key role in projects in RA, including but not limited to regulatory precedence and landscape research, preparation of regulatory submission documents. In addition, the fellow will have opportunities to collaborate with other departments.
Upon completion of the program, the fellow will understand the fundamentals of regulatory science, the specific responsibilities of various Regulatory Affairs functions, and the role of other functions in the drug development process.
Train as a member of the Regulatory Affairs team to gain insight into the various roles within Regulatory Affairs and other functional groups.
Interact with cross-functional partners including Clinical, Manufacturing, Research and Development, Drug Safety, Toxicology, Clinical Pharmacokinetics, Quality Assurance, Project Management, Medical Writing, Publishing, Medical Affairs, and Marketing to discuss issues specific to Regulatory Affairs, and apply the information acquired.
Review scientific documents supporting regulatory filings, review current regulations and guidelines, and perform other regulatory intelligence, as needed.
Gain knowledge of overall drug development procedure and role Regulatory Affairs play in devising drug development plan and product approval.
Identify regulatory team needs and data gaps and collaborate internally to help drive appropriate solutions and projects.
Develop, implement, and present a longitudinal research project.
Serve as a rotation preceptor to pharmacy students.
Collaborate with the other Neurocrine co-fellows.
Complete required graduate coursework at the University of Southern California with the opportunity to complete a Certificate in Regulatory Sciences.
Participate in the University of Southern California, School of Pharmacy Professional Development and Leadership Retreat.
PharmD, MD, or PhD in applicable field from an accredited university within pervious 5 years
Good oral and written communication skills, ethics, professionalism, leadership, and an interest in the biopharmaceutical industry
Minimum GPA of 3.0
In addition to applying through USC, please submit a Curriculum Vitae and Letter of Intent through American Society of Health-System Pharmacists (ASHP) Personal Placement Service (PPS) to request a first-round interview.
Application materials are due to PPS by November 30, 2022
PPS portal opens October 5nterviews will be conducted at the ASHP Midyear Clinical Meeting, which will take place the week of December 4-6
Final due date for all application documents to USC is December 9, 2022
The University of Southern California is one of the world’s leading private research universities. An anchor institution in Los Angeles, a global center for arts, technology and international trade, USC enrolls more international students than any other U.S. university and offers extensive opportunities for internships and study abroad. With a strong tradition of integrating liberal and professional education, USC fosters a vibrant culture of public service and encourages students to cross academic as well as geographic boundaries in their pursuit of knowledge.