Regulatory Affairs Officer, IQVIA Biotech

At IQVIA Biotech, we partner with visionary biotech companies to transform innovation into patient impact. With dedicated teams, deep therapeutic expertise, and a biotech-tailored delivery model, we accelerate clinical development from early phase through global registrational studies.

Job Overview
As an experienced individual contributor within IQVIA Biotech’s Regulatory Affairs team, you’ll operate under limited supervision to drive regulatory strategy and delivery across complex, multi‑stakeholder projects. You’ll lead cross‑functional regulatory workstreams, prepare and review submission materials, and act as a subject‑matter expert (SME) throughout the clinical trial lifecycle. You’ll build trusted relationships with sponsors, present at bid defenses, manage scope and budget for assigned projects, and contribute to team capability by reviewing SOPs and delivering targeted training. This role reports into Regulatory Affairs leadership and collaborates closely wi...