Regulatory Affairs Manager
Current- Responsible 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