Regulatory Affairs Consultant

Job Summary

A company is looking for a Regulatory Affairs Consultant I.

Key Responsibilities

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

Required Qualifications

• 3-5 years of experience in regulatory operations
• Experience with submission delivery support for the US and Europe
• Knowledge of electronic document management and publishing tools
• Expertise in health authority guidelines and regulations
• Experience overseeing publishing vendors is preferred