The Opportunity: Support regulatory review activities related to site activation across clinical studies. Manage Regulatory Affairs contracts and invoices; maintain and update internal RA tracking tools. Archive regulatory documents in accordance with internal procedures and maintain the regulatory query tracker. Support regulatory submission workflows in Veeva. Co-host Regulatory Sub-Team meetings, including agenda preparation and documentation of action items. Participate in RAxROxMW workshops and Regulatory Strategy Forums. Conduct weekly one-on-one meetings with the RA Manager to review priorities and progress. Build and maintain working knowledge of FDA regulations, guidances, and applicable regulatory requirements.
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Career Level
Intern