Below is the job descriptions for your reference:
Please note that this role is different from a Senior Associate in Regulatory Affairs. Regulatory Affairs provides content of submissions and Regulatory Operations assembles the content per technical specifications and transmits to the Regulatory Agency.
- Formatting and Publishing Able to independently format, publish, transmit and archive all submission types.
- Develop templates.
- Regulatory Intelligence Advanced understanding of regulations and guidance associated with submissions.
- Project Management and Communication
- Able to answer some technical questions for many submission types.
- Attend Regulatory Sub team meetings with main publishing contact to provide support.
- Able to answer most technical questions for many submission types.
- Able to troubleshoot and resolve some issues with critical computer application systems, e.g., MS Word and InSight Publisher.
- The candidate should have at least 6+ years of experience in Regulatory Operations and must be certified in InSight Publisher or be able to provide training completion certificates from Liquent.
- Basic computer skills in MS Office and Adobe Acrobat, experience with scanners and copiers, able to multi-task and set priorities, pay close attention to details, work in team environment.
- Computer skills in InSight Publisher and Acrobat plug-ins such as ISI Toolbox, ability to publish routine submissions.
- Work with functional areas to coordinate filings and have the knowledge and experience to publish more complex submissions.
- Bachelor's Degree desirable.