Intern - PDM - CMC Regulatory Affairs, Strategy and Operations

Gilead Sciences•Foster City, CA

1d•Hybrid

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.

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).
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).

Nice To Haves

Preferred degree level: Graduate, MBA
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
Strong interest in pharmaceutical development, Regulatory Affairs, artificial intelligence, or the intersection of science, regulation, and emerging technology.
Familiarity with generative AI, large language models, data science, automation, or related technologies is desirable
Ability to conduct structured research, synthesize information from multiple sources, and communicate findings clearly.
Comfortable working with ambiguity and contributing to an early-stage project where the solution and approach will evolve through experimentation.
Interest in understanding the limitations and risks of AI and designing approaches that preserve appropriate human judgment and oversight.

Responsibilities

Support definition and early design of a governed AI-enabled capability intended to simulate elements of health authority review of CMC regulatory submissions.
Work with CMC Regulatory Affairs subject matter experts to understand how experienced regulatory reviewers assess Module 3 content and identify potential deficiencies, inconsistencies, missing rationale, and likely areas of regulatory questioning.
Research relevant health authority guidance, regulations, review practices, and publicly available regulatory information to inform the design of the capability.
Support development and testing of an early minimum viable product or prototype using approved technologies and information sources.
Develop approaches for evaluating the quality and usefulness of outputs, including identification of false positives, unsupported conclusions, missed issues, and other limitations.
Support Regulatory Policy & Advocacy colleagues in researching and assessing emerging health authority requirements, regulatory guidance, policy developments, and industry trends.
Explore opportunities to apply AI and automation to regulatory intelligence activities, including information identification, synthesis, classification, and retrieval.
Showcase your work with a final presentation (PPT) near the conclusion of your internship.