Job Title: Regulatory Affairs Specialist – Plasma LicensingJob Description
This role supports plasma regulatory affairs by preparing, submitting, and maintaining licensing, registration, and accreditation documentation for source plasma collection activities in the United States, Canada, and other global regions. You will help ensure compliance with regulatory authorities and industry associations by managing applications, monitoring submissions, and communicating requirements to internal stakeholders. This position offers the opportunity to contribute to life‑changing therapies within a mission‑driven organization focused on improving patient lives.
Responsibilities
+ Accurately prepare regulatory applications required by federal and other regulatory authorities, as well as industry affiliates, for review prior to submission.
+ Research internal documents, complete applications and forms, prepare cover letters and summaries, and assemble and format applications...