Regulatory Operations Director

Job Summary

A company is looking for an Associate Director, Regulatory Operations and Intelligence.

Key Responsibilities

• Collaborate with Regulatory Leads to develop submission plans and perform critical reviews of regulatory documents
• Format and publish regulatory documents in compliance with health authority requirements and conduct final reviews of submissions
• Lead the analysis of global regulatory developments and manage regulatory records and documentation in controlled systems

Required Qualifications

• Master's or Bachelor's degree in a scientific discipline preferred; equivalent work experience will be considered
• 7+ years of industry-related experience in a regulatory publishing function
• 5+ years of experience with specialized regulatory submission and publishing systems
• Experience in FDA regulatory submissions for drugs and knowledge of CTD/eCTD format
• Experience with technical writing and project management is a plus