USC-Neurocrine Biosciences Fellowship in Regulatory Affairs
The one-year Regulatory Affairs (RA) Fellowship based in San Diego, CA 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, Labeling, and Publishing as well as having the opportunity to work on projects in other cross-functional departments such as Quality Assurance, Project Management, and Medical Writing.
The Fellowship will provide hands-on training, experience and mentorship while working with cross-functional partners on Neurocrine developmental programs. The fellow will play a key role in facilitating timely submission of documents to regulatory agencies. In addition, the fellow will have opportunities to work on several projects inside and outside of RA in collaboration with other departments as part of a comprehensive training program.
Upon completion of the program, the fellow will understand the various Regulatory Affairs functions and interactions with key cross-functional partners.
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, Labeling, 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 USC-Neurocrine Medical Affairs co-fellow.
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
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, 2021
Interviews at the ASHP Midyear meeting are limited and are granted on a competitive basis. Please apply for an interview by submitting your CV and letter of intent through the PPS portal.
Request an Interview
To be considered for an interview, submit your CV and letter of intent as file attachments. Please address the letter of intent to Valmik Doshi, MS.
Document type: PDF
Document name: Last Name_First Name_CV.pdf
Letter of Intent
Document type: PDF
Document name: Last Name_First Name_RA_Letter.pdf
The letter of intent should address your career goals in industry and why you are interested in the USC-Neurocrine Biosciences Regulatory Affairs Fellowship.
Submit Application to USC School of Pharmacy Online Portal
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.