Global Regulatory Submissions & Publishing Manager

Otsuka Pharmaceutical Co., Ltd seeks an experienced Manager of Regulatory Operations to coordinate regulatory publishing deliverables for assigned programs, ensuring on-time submissions and adherence to health authority requirements. This role oversees staff and vendor partners, driving process improvements and maintaining lifecycle submissions. The candidate will have 5+ years of regulatory operations experience, and deep knowledge of FDA/EMA/HC/Swiss Medic regulations, eCTD formatting,