
Senior Regulatory Affairs Associate (RA Generalist) - FSP
FSP Senior Regulatory Affairs Associate supporting global and local regulatory teams for products in Australia (and experience including New Zealand). Responsibilities include post‑authorization lifecycle activities (variations, renewals, PSURs), preparing local submission documentation (Module 1), managing health authority interactions, impact assessments for CMC/label changes, use of document management systems, project and client reporting, and supporting regulatory compliance and inspections. Requires a bachelor’s in a scientific/technical discipline and 3+ years’ industry experience in Australia/NZ; role is remote with periodic office attendance.














