Regulatory Affairs Coordinator (Irvine)

RA Coordinator I

• Prepares, dispatches and files routine Regulatory Affairs documentation
• Collaborates with Regulatory Affairs staff to assure adequate prioritization, triage, preparation and dispatch of routine regulatory submissions and / or labeling creation
• Finalizes high quality submissions and labeling by editing and formatting documents while adhering to current regulatory guidelines, internal processes and procedures, style and document standards and utilizing company publishing tools, technology, and systems.
• Performs operational tasks including publishing, archiving and uploading of documents to document management systems / tools; organizes and maintains components of regulatory submissions and labeling including template preparation, scanning, printing and / or filing.
• Collects documents to import, edit and / or create in electronic documentation storage and retrieval systems.
• Establishes and organizes electronic structures for local storage of regulatory submissions and / or labeling, including migration and maintenance of regulatory documents.
• Participates on project teams for the publishing of regulatory documents and labeling creation.
• Provide authentication of documentation and support as a notary when needed.
• Compiles, manages, tracks and reports submission related metrics
• Coordinates legalization and / or apostille of regulatory documentation for Health Authority submissions as needed
• Routes documentation in the Quality Management Systems (e.g. QUMAS, Agile, etc.) as needed
• Conducts impact assessments for regulatory external requirements (e.g. standards, guidance documents, regulations, etc)
• Assists in preparing training materials and conducting training for users of electronic documentation systems and authors of regulatory documents.
• Maintains document design consistency for all documents to ensure compliance with company document design standards, including the use and maintenance / creation of templates.
• Helps drive process consistency and standards within assigned region. Collaborates with other team members to drive that consistency across all the regions.