Regulatory Affairs Specialist

Regulatory Affairs Specialist- Post Marketing (FSP - Sponsor Dedicated)

ICON plc is a world‑leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing

• Undertaking variable duties based on project requirements, primarily within Pharmaceutical, Biotechnology, or Biologics Regulatory Affairs, with potential involvement in related areas.
• Contributing to regulatory submissions team activities, including preparation, compilation, and submission of regulatory documents such as CT/IND, MAA/NA, variations/lifecycle submissions, DSUR, PSUR, renewals, and agency briefing documentation.
• Managing and implementing label review, translation requirements, fee calculations, and other aspects for regulatory submissions.
• Providing inpu...