Regulatory Operations Lead — eCTD Submissions & Strategy

Otsuka seeks a Manager of Regulatory Operations to coordinate high-quality, on-time regulatory publishing deliverables for assigned programs. You will lead electronic submissions, liaise with global affiliates, and drive process improvements to ensure compliance with health authority requirements.

The role requires 5+ years in regulatory operations, strong eCTD publishing skills, and experience with multiple regulatory bodies. Collaboration across departments and vendors is essential for success.