Intern – CMC Regulatory Affairs - Biologics

Job Description

Intern – CMC Regulatory Affairs - Biologics

Foster City, CA

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 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.

Key Responsibilities will include, but are not limited to the following:

• Under general supervision and guidance of RA CMC Foster City team, 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.

• 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.

• Analyze previously received Health Authority questions & answers and commitments to summarize regulatory trends and expectations.

• Work cross-functionally within a matrixed organization.

• Showcase your work with a final presentation (PPT) near the conclusion of your internship

Required Qualifications:

• Must be at least 18 years old

• Must have a minimum GPA of 2.8

• Authorized to work in the United States without Sponsorship now or in the future or CPT/OPT through your University.

• Must be currently enrolled as a full-time student at an accredited U.S. based university or college and enrolled in the fall semester after the completion of the internship.

• Must be a Rising Sophomore, Junior, or Senior in undergrad or enrolled in an advanced degree program.

• Must be able to complete a 10-12 consecutive week internship between May and August

• Must be able to relocate if necessary and work at the designated site for the duration of the internship.

Preferred Qualifications:

• Preferred Degree qualification: Undergraduate/Graduate

• Proficiency with MS Office Suite

• Ability to identify issues and seek solutions

• Ability to work both independently and collaboratively

• Demonstrated commitment to inclusion and diversity in the workplace

• Efficient, organized, and able to handle short timelines in a fast-paced environment

Gilead Core Values:

• Integrity (Doing What’s Right)

• Inclusion (Encouraging Diversity)

• Teamwork (Working Together)

• Excellence (Being Your Best)

• Accountability (Taking Personal Responsibility)