Senior Manager Regulatory Affairs

Leading the Japan team, the full-time Senior Manager Regulatory Operations will manage eCTD publishing and submission processes, oversee regulatory information management systems, and support regulatory technology implementation while working remotely. Key responsibilities Own end-to-end eCTD publishing, submission, and document management for major global regulatory submissions, ensuring compliance and timely delivery Administer and enhance global regulatory information management systems and processes to support the Japan team and its clients Manage and develop a team of regulatory operations professionals, fostering growth and succession readiness within the team Required qualifications At least 10 years of experience in the pharmaceutical industry with a focus on Regulatory Operations 5-10 years of people management experience in a regulatory operations context 5+ years of experience with eCTD publishing and managing major regulatory submissions Experience with regulatory technology implementation, including tools like Documentum and Veeva Vault Bachelor's degree or equivalent experience in Life Sciences, Regulatory Affairs, or a related field