Regulatory Affairs AssistantBookmark This
Apple Blossom Naturals
3273 421st Ave NE
DescriptionWe are in need of a regulatory affairs assistant to perform label specific research within FDA regulations.
ResponsibilitiesCollect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
Timely compile materials for license renewals, updates and registrations
Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
Review labeling and labels for compliance with regulatory requirements
Review changes to existing products and SOPs to define the requirements for regulatory submissions
Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes
Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.
RequirementsCoursework or Experience with the drug registration process
Experience with cosmetic and/or drug market
Understanding of FDA requirements and processis