Senior Associate Regulatory Operations
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.
Planning, publishing (eCTD), reviewing and delivery of lifecycle submissions to Health Authorities within required timelines.
Advanced understanding of regulations and guidance's associated with submissions, including and most importantly in eCTD and lifecycle submissions.
Project Management and Communication
Able to answer technical questions for many submission types.
Attend Regulatory Submission team meetings, and act as the publishing SME on behalf of the Regulatory Operations function.
Able to answer technical questions for many submission types. Able to troubleshoot and resolve issues with critical computer application systems, e.g., MS Word, Adobe and InSight Publisher.
Skills and Requirements
- At least 3 years of experience in Regulatory Operations, and eCTD lifecycle submissions.
- Must be certified in InSight Publisher or be able to provide training completion certificates.
- Proficiency in publishing eCTD submissions and using related tools, including InSight Publisher and Acrobat plug-ins such as ISI Toolbox.
- Intermediate computer skills in MS Office, Adobe Acrobat and Liquent tools.
- Able to multi-task and set priorities, pay close attention to details, and work in team environment.
- Ability to collaborate with functional areas to coordinate filings and have the knowledge and experience to publish more complex submissions.