Intern CMC Regulatory Affairs - Biologics
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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. A summer internship is available in the Regulatory Affairs CMC (chemistry, manufacturing, and controls) Department at the Foster City, CA, campus of Gilead Sciences. The candidate should be enrolled in an Undergraduate/Graduate Program with a focus in chemistry, biology, regulatory affairs, or a closely related subject. The summer intern will provide support in the preparation of regulatory CMC submissions for investigational and marketed applications in line with regulatory requirements, company policies, and procedures. Under general supervision and guidance of the RA CMC Foster City team, you will develop required regulatory skills and knowledge for assisting in the preparation of regulatory submission documents including notifications, supplements, and annual reports to clinical trial applications and marketing authorizations for assigned territories, as applicable. You may contribute to local process improvements with potential impact to the Regulatory Affairs CMC Department, including but not limited to computerized information, regulatory, and change control systems. Additionally, you will analyze previously received Health Authority questions & answers and commitments to summarize regulatory trends and expectations. This role will require you to work cross-functionally within a matrixed organization and showcase your work with a final presentation (PPT) near the conclusion of your internship.
