Regulatory Affairs Specialist

The Regulatory Affairs Specialist provides document assistance to support the  team in obtaining registrations for company products, monitors and analyzes document request workload and provides solutions for continuous improvement. 

Essential Duties and Responsibilities:

Assist the team in the following activities: Prepare applications for official certificates and related official and administrative documents to support regulatory processes.Official certificates (USDA and FDA primarily)Letters of authorizationOther administrative documents generated by the teamCoordinate legalization processes for official certificates and related documents to support submissions.Act as the group Public Notary.Maintain SharePoint Site Request System: Generate metrics to assess workload and workflow efficiency Generate monthly reports to monitor and analyze document request workflow, identify issues and propose solutions   Liaise with BT to update the system (workflows, users and routings, troubleshooting, etc.)    Build and provide technical support for dossier binder creation in Veeva Vault:Create binders in Veeva Vault for dossier compilation as requested by team membersLocate technical files for dossier compilation in Veeva VaultLiaise with BT for Veeva Vault maintenance or changes to binders as requested by team membersMaintain SharePoint Site for regulatory requirements