Regulatory Operations Senior Associate _ InSight Publisher in San Rafael, CA

$80K - $100K(Ladders Estimates)


San Rafael, CA 94901

Industry: Pharmaceuticals & Biotech


5 - 7 years

Posted 6 days ago

  by    Hazel D'Lima

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.

Valid Through: 2019-11-4

$80K - $100K