The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation... for FDA 510(k) submissions and documentation for other international regulatory bodies. Responsible for managing...
Pharmacovigilance & Drug Safety Specialist (PharmD) Bring your clinical lens to the world of drug safety and reporting.... Key Responsibilities: Analyze adverse event reports and clinical trial safety data. Prepare regulatory submissions (e.g...
of Regulatory Affairs on claims substantiation workflows, asset approvals, and compliance documentation systems Risk Assessments... and practice regulations across states Coordinate with the Director of Regulatory Affairs, who leads product and marketing claims...