Regulatory Operations Director

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

Created: 2026-03-05