Translational Regulatory Intern, Oncology

Location: Gaithersburg, MD

We are currently seeking juniors and master-level students working towards a degree in biological sciences, health sciences, or a related field discipline for a 10-12 week internship during the summer of 2024.

Objectives/Goals of the Position:

The intern will gain knowledge in:

• Principles of Regulatory Affairs and develop an understanding of the regulatory requirements for bringing medicines to patients;
• Project management of regulatory submissions;
• Become familiar with Regulatory strategy;
• Become familiar with documentation in a regulated environment; and
• Improve interpersonal and communication skills by participating in global, cross-functional project teams.

Primary Duties:

• Assist with regulatory strategy for project teams and other functions as needed;
• Contribute to and/or lead planning, preparation, and delivery of regulatory submissions;
• Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements;
• Contribute to and/or lead process improvement;
• Provide support to the group for assigned non-drug product roles & responsibilities, e.g., act as a designated point of contact or superuser.