Intern - Development - Global Regulatory Policy & Intelligence, Regulatory Affairs
About The Position
As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance our company’s mission but will allow you to gain real world experience at one of the most innovative organizations in the world. You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. Global Regulatory Policy & Intelligence (GRPI) team monitors emerging regulations, evaluates their impact, and supports Gilead’s engagement with health authorities and industry trade associations on consultations that shape future regulatory frameworks. The intern will analyze clinical trial modernization topics and synthesize evolving regulatory expectations for (1) how future clinical studies will be designed and (2) how evidence will be evaluated by health authorities for marketing approval and other regulatory decisions. The intern will assess potential implications for Gilead's portfolio and prepare summaries that support internal regulatory strategy and product development.
Requirements
- Must be at least 18 years of age at the start of the internship.
- Must be enrolled full‑time in a Bachelor’s, Master’s, MBA, JD or PhD program at a nationally accredited U.S. college or university, with continued full‑time enrollment required in the Fall semester following the internship.
- Must be currently enrolled as an undergraduate (freshman, sophomore, junior, or senior) or as a graduate/doctoral student.
- Must have a minimum overall cumulative GPA of 2.8 at the time of application and hire (official transcripts will be requested).
- Must be independently authorized to work in the United States now and in the future (current or future work authorization must not require school or employer sponsorship) official transcripts are required.
- Must be able to commit to a full‑time internship lasting 10–12 consecutive weeks between May and August.
- Must be willing and able to work at the designated site for the duration of the internship (relocation may be required). All internships are hybrid; fully remote roles are not offered.
Nice To Haves
- Preferred degree level: Graduate/MBA/PhD/JD/PharmD
- Preferred major: Computer Science, Statistical Programming, Epidemiology, Biostatistics, Molecular and Cell Biology, Biochemistry, Mathematics, Biology, Regulatory Affairs, Regulatory Science, Biomedical Studies or Clinical Translational Research
- Proficiency with Microsoft Office (MS Office) tools, such as Word, Excel, PowerPoint, and Outlook
- Strong problem‑solving skills, with the ability to identify issues and proactively seek solutions
- Ability to work effectively both independently and as part of a team in a collaborative environment
- Demonstrated commitment to inclusion and diversity, including the ability to work respectfully with individuals from diverse backgrounds
- Highly organized, detail‑oriented, and able to manage competing priorities in a fast‑paced environment with short timelines
Responsibilities
- Research emerging regulatory and scientific approaches for innovative evidence generation (e.g., statistical methodologies and trial designs)
- Evaluate FDA, EMA, ICH, and industry trade association policy developments related to: Regulatory expectations for demonstrating substantial evidence of investigational product effectiveness, Model-Informed Drug Development and Quantitative Medicine, including disease modeling, trial simulation, and others, Innovative clinical trial designs, including master protocols, adaptive designs, Bayesian approaches, Artificial Intelligence (AI)-enabled approaches, and more
- Assess FDA, EMA, and ICH regulatory trends and guidance documents that may impact Gilead's clinical development programs, regulatory interactions/submissions, and compliance activities
- Develop regulatory intelligence summaries to inform regulatory strategy and product development in Virology, Oncology, and/or Inflammation
- Develop presentations, briefing materials, and communications to raise awareness of emerging regulatory developments, policy consultations, and initiatives
- Translate project findings into actionable insights to support business objectives and decision-making across Regulatory Affairs and other Development functions
- Showcase your work with a final presentation (PPT) near the conclusion of your internship
Benefits
- paid company holidays
- sick time
- housing stipends for eligible employees
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What This Job Offers
Job Type
Full-time
Career Level
Intern
Education Level
Associate degree
