Overview GENERAL SUMMARY OF POSITION: Responsible for the coordination and preparation of document packages for regulatory submissions for an FDA regulated Biologics research & manufacturing organization. Compiles all materials required for submissions, license renewal and annual registrations. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. Part-time candidates will be considered for this opportunity. ResponsibilitiesMAJOR RESPONSIBILITIES: Prepares paper and electronic regulatory submissions. Assists with the collection and verificat
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