A pharmaceutical company that focuses on the development and commercialization of medicines for Central Nervous System disorders is seeking a remote Manger/Sr Manager Regulatory Operations for a 6-month contract with potential of extension and conversion!
Responsibilities:
- Publishing, QC, and transmittal of eCTD submissions, as well as document formatting and report-level publishing.
- Using eCTD publishing and document management (Veeva Vault RIM), publish eCTD submissions and reports in alignment with health authority guidelines and industry best practice
- Ensure formatting is applied consistently according to Style Guide
- Prepare PDF documents for inclusion in regulatory submissions by editing bookmarks, hyperlinks, and other elements to ensure submission-readiness
- QC published eCTD submissions and reports
- Support authors and contributors to documents/reports to be included in regulatory submissions by advising on use of Veeva Vault RIM
- For clinical study reports, work with SMEs/authors to track status of appendices and manage overall timelines for completion
Requirements:
- Bachelors degree in life sciences, business admin, information technology or related
- 7-10 years in Regulatory Operations
- Experience in vendor selection, configuration, and implementation of regulatory information management systems and publishing systems
- Experience using Acrobat, DXC Toolbox, or other authoring templates
If interested in the Manger/Sr Manager Regulatory Publishing role, apply now!
