Regulatory Associate

Job Summary   The Regulatory Associate is responsible for ongoing support of regulatory activities, including preparation and submission of annual reports, PMS reports, foreign registrations, labeling change requests and tracking of field action alert documentation. Additionally, this position will support the preparation and submission of supplements and amendments to FDA for approval, which includes responding to deficiency letters. This role will also support other team members, as needed. Performs tasks that support quality system compliance with US FDA Quality System Management Regulation (21 CFR 820) and biologic...