Manager I, Regulatory Affairs Operations - Remote

Overview

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

In Short

• Create and Maintain Content Plans within Veeva Vault RIM (or via Excel), understanding of eCTD Hierarchy/Modules and content planning.
• Assist with planning, managing, archiving of submissions/regulatory authority correspondence, Ad & Promo submissions, dossier lifecycle management.
• Manage and draft responses to Health Authorities' queries.
• 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.
• Excellent organization, written/verbal communication and attention to detail.
• Proficiency in electronic submission tools and software, such as eCTD and regulatory information management systems.
• Experience and proficiency with project management tools and software such as Microsoft Word, Project, Excel, etc.

Requirements

• Bachelor’s degree in science or health-related discipline or equivalent experience.
• 5+ years of Regulatory Affairs Operations Experience, with a focus on publishing and/or submissions management.
• In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards.
• Experience working with Veeva Regulatory Information Management System Vault is required.
• Experience in interpreting regulations, guidelines, and policy statements.
• Demonstrated ability to contribute to a continuous learning and process improvement.
• Strong analytical skills, good attention to detail.
• Ability to work concurrently on projects with specific instructions.

Benefits

• Hybrid work environment; remote work may be considered.
• Comprehensive benefits including health, dental and vision insurance.
• Generous paid time off, including vacation, holidays, and personal days.
• Opportunity to work in a collaborative and innovative culture.
• Some travel may be required – up to 20%.