Regultory Affairs Associate

Looking for someone detail-oriented, there are written instructions they will be expected to follow, as well as verbal instructions. This person needs to be able to work independently and prioritize their work. They will be routinely corresponding with Regulatory authorities, so communication skills will be important. A background in regulatory quality focus



This position is scheduled to be hybrid. M Tu W in office and Th Fr remote. However, this will depend on whether the candidates have remote work experience and have their home set up to perform the work.



Summary:

Regulatory Affairs oversees the licensing, surveillance, and other regulatory activities associated with Source Plasma collection within the United States of America, Canada and Rest of World (ROW). This includes activities associated with US Food and Drug Administration (FDA) licensure and registration (biologics (BLA), medical device), Health Canada licensing, Clinical Laborat...