Regulatory Operations Associate


This is regarding excellent job opportunity with my client...!!!  

Title:  Regulatory Operations Associate

Location:  REMOTE- company in California

Duration:  12 months

•    Formatting and Publishing Able to independently format, publish, transmit and archive all submission types. Develop templates. Regulatory Intelligence Advanced understanding of regulations and guidance’s associated with submissions. Project Management and Communication Able to answer some technical questions for many submission types. Group Representation Attend Regulatory Sub 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.

•    Having Insight Publisher Certification is a Major PLUS  

Thanks & Regards,

Rajendra Mane



16192, Coastal Highway, Lewes, Delaware, USA

Phone: 302-200-2321


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