EPM Scientific Hiring for Manager/Sr. Manager, Regulatory Operations Job at Remote Full Time

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!