We are seeking a highly skilled Senior Manager/Associate Director, Regulatory Operations to support and help drive regulatory success and shape the development of life-changing treatments. In this role, you will provide operational leadership supporting global regulatory submissions, regulatory information management, regulatory technology, publishing, and Health Authority interactions across development programs.
This individual will serve as the business lead for Regulatory Information Management, supporting implementation and optimization of Veeva RIM Basics while helping establish internal publishing capabilities and scalable Regulatory Operations processes.
The successful candidate will combine strong technical Regulatory Operations expertise with systems implementation experience, regulatory publishing knowledge, and a passion for process improvement. This role will partner closely with Regulatory Affairs, Medical Writing, Clinical Development, CMC, Quality, and external partners to ensure high-quality, compliant, and timely regulatory submissions.