Regulatory Affairs Manager

Job Summary

A company is looking for a Regulatory Affairs Manager II.

Key Responsibilities

• Manage eCTD submission processes for global development and lifecycle management
• Coordinate publishing deliverables and oversee outsourced publishing activities
• Ensure compliance with regulatory agency standards and conduct quality control checks on submissions

Required Qualifications

• 3-5 years of experience in regulatory operations, specifically in submission delivery support for the US and Europe
• Experience overseeing publishing vendors is preferred
• Expert knowledge of submission-related health authority guidelines and regulations
• Competency in electronic document management and submissions publishing tools
• Ability to drive deliverable timelines and set quality standards with stakeholders