This is NOT the formal application. Please apply through the USC application portal found on this page to be considered for this position: https://provost.sma.usc.edu/prog/usc_alfred_e_mann_school_of_pharmacy_and_pharmaceutical_sciences_fellowship_2026-2027/ 

Applications submitted through PPS will only be used to contact final-round candidates for interviews at ASHP Midyear Meeting. 

Dear Prospective Fellowship Candidate, 

Gilead Sciences, Inc. is pleased to introduce a two-year Global Regulatory Affairs Oncology Fellowship Program, designed to support the development of future regulatory professionals in the biopharmaceutical industry. This program offers fellows a comprehensive immersion into the regulatory landscape of oncology drug development, providing hands-on experience and strategic insight into the processes that ensure compliance with U.S. FDA and global Health Authority requirements. In alignment with Gilead’s mission to advance innovative oncology therapies, the fellowship aims to equip participants with the knowledge, skills, and collaborative expertise needed to navigate complex regulatory pathways and contribute meaningfully to the development of treatments that improve patient outcomes worldwide.

Duration: 2 years (July 1, 2026 – June 30, 2028) 

Positions Available: 1 

Location: Foster City, California 

Global Regulatory Affairs, Oncology Fellowship Activities:

Program objectives:
• Provide in-depth knowledge of the drug development process, including preclinical and clinical requirements, regulatory submissions, and global Health Authority guidelines specific to oncology therapeutics.
• Develop expertise in interpreting and applying regulatory intelligence to ensure compliance with U.S. FDA and international Health Authority requirements.
• Strengthen understanding of the strategic role of Regulatory Affairs in navigating complex regulatory landscapes, including oncology-specific challenges such as accelerated approval pathways and companion diagnostics.
• Build proficiency in preparing and managing regulatory submissions, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs), with a focus on oncology products.
• Foster the ability to collaborate effectively with cross-functional teams and contribute to the
development, licensing, and global marketing of oncology therapies, ensuring alignment with regulatory standards and patient needs.

Program Activities:
• Support the development and execution of regulatory strategies for oncology drug development programs, including the preparation of INDs, NDAs, and BLAs.
• Collaborate with Global Development Teams—including clinical, manufacturing, and commercial functions—to ensure regulatory compliance throughout the product lifecycle.
• Assist in the creation of regulatory documentation, including clinical study reports and labeling content for oncology product submissions.
• Participate in planning and executing Health Authority interactions, such as FDA meetings and international regulatory consultations, to support approvals and post-marketing commitments.
• Conduct regulatory intelligence activities, including analysis of global guidelines, precedent, and competitor data to inform development strategies.
• Engage with Health Authorities and internal stakeholders to address regulatory queries and support the approval and commercialization of oncology therapeutics.
• Fellows may complete graduate coursework at the University of Southern California with the opportunity to pursue a Graduate Certificate in a variety of fields.
• Fellows will have opportunities for leadership, teaching, and professional growth, including mentoring PharmD students and engaging in professional development activities such as goal setting, strengths identification/assessments, advising, coaching, and mentoring at USC.

Minimum Application Requirements: The candidate must be a US citizen/permanent resident and have completed a PharmD, MD, PhD or equivalent doctorate degree from an accredited college or university within five years of initial appointment and a minimum doctoral program GPA of 3.0, have good oral and written communication skills, ethics, professionalism, leadership, and an interest in the biopharmaceutical industry. 

Interview Requests: Interviews are limited and will be scheduled on a rolling basis. For early consideration, please submit your application, including your CV and a letter of intent, by November 30, 2025 and at the following link: https://provost.sma.usc.edu/prog/usc_alfred_e_mann_school_of_pharmacy_and_pharmaceutical_sciences_fellowship_2026-2027/ 

Please follow the document conventions listed below:   

CV  

1. Document type: PDF
2. Document name: Last Name_First Name_CV.pdf   

Letter of intent  

1. Document type: PDF
2. Document name: Last Name_First Name_Letter_ Program of Interest.pdf   

Additional information and application materials are available at:  https://mann.usc.edu/program/fellowship-programs/admissions/ 

About USC

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.

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