Regulatory Operations Manager

Job Summary

A company is looking for a Regulatory Operations Manager (Submission Delivery).

Key Responsibilities

• Manage eCTD submission processes for global development and lifecycle management
• Coordinate publishing deliverables and oversee outsourced activities for assigned products
• Ensure timely and quality submission deliverables from the authoring community

Required Qualifications

• Experience in regulatory operations within the pharmaceutical industry
• Knowledge of eCTD submission standards and regulatory requirements
• Ability to manage multiple projects and deadlines effectively
• Experience in coordinating with cross-functional teams
• Proficiency in electronic submission processes and tools