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 guidances associated with submissions. Project Management and Communication Able to answer some technical questions for many submission types. Group Representation Attend RegulatorySub team meetings with main publishing contact to provide support. Technical 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 3 years of experience in Regulatory Operations and must be certified in InSight Publisher or be able to provide training completion certificates from Liquent. Skills Required 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. Job Level/Complexity Uses professional concepts and company’s policies and procedures to solve a wide range of moderate problems in imaginative and practical ways. Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Bachelor’s Degree desirable.