Administrator, Regulatory Support

Overview:
STATEMENT:
Provides regulatory administrative support to Regional Regulatory Affairs Teams in the Americas.
Work cross-functionally with various domestic and international departments, necessary for completion of all printed components, FSF, compliance reviews & CFS for GRA teams in the Americas.
DETAILED RESPONSIBILITIES/DUTIES:
- Develops new and revised printed components through defined workflows in Agile, ensuring their regulatory compliance prior to printing.
- Responsible for routing printed component ECOs through the Agile system and follows up with others pending their approvals of the PC ECOs.
- Maintains and updates product databases.
- Requests documents such as affidavits, CFS, Additives letters, notifications, and certifications and conducts follow ups to assure completion.
- Reports project statuses to the direct supervisor on a weekly basis, through meetings established by the department head, or through reporting, as necessary.
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