Regulatory Affairs Manager
CurrentResponsible for submission of product samples and lot release protocols to Health Authorities for product release. ▪ Work cross-functionally with Operations and Planning to coordinate lot release plan. ▪ Communicate directly with government health authorities regarding status of product testing and release. ▪ Submission of Lot Distribution reports and Establishment Registrations to the Food and Drug Administration (FDA). ▪ Subject Matter Expert of Regulatory Labeling activities for North American Global Business Unit