Sr Regulatory Operations Associate at Pharmaceutical Company in Petaluma, California, United States —
- Pharmaceutical Company
- Petaluma, California, United States USA
- 10/10/19 2019-10-10
Job ID: 61613
Duties: 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 6+ 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.