Manager I, Regulatory Affairs Operations

About the Role

The Manager I, Regulatory Affairs Operations will report to the Director, Regulatory Affairs Operations, and will primarily assist in managing Electronic Document Management System (Veeva Vault RIM) and regulatory submissions activities.

Let’s talk about some of the key responsibilities of the role:

• Create and Maintain Content Plans within Veeva Vault RIM, understanding of eCTD Hierarchy/Modules and content planning.
• Assist with planning, managing, archiving of submissions/regulatory authority correspondence, Ad & Promo submissions, dossier lifecycle management. Maintain compliance to regulatory requirements for annual reporting, etc.
• Support RA submissions team/s with project management activities, tasks and tracking.
• Assist with coordination and communication of regulatory submissions with external Publishing vendors.
• Ability to work with firm deadlines and adapt quickly to changing requirements and priorities.
• Assist in Reg Ops team management and help to develop fully functional regulatory operations team, including processes and systems.
• Excellent organization, written/verbal communication and attention to detail.
• EDMS & Submission Technology: Proficiency in elec