Job Description
- As an integral member of Otsuka’s regulatory operations team, provides regulatory publishing and submission assignments, monitoring, and oversight, as well as a lead or support for GRA efforts
- Ensures assigned submissions are made with quality, on-time, and within established budgets
- Acts as primary liaison while coordinating regulatory publishing activities for all R&D functions
- Liaise with affiliates for coordinating and publishing defined content
- Owns delivery of electronic regulatory submissions to ensure processes are followed, as well as quality and timelines are met in accordance with health authority requirements and Otsuka leadership established schedules
- Designs and implements processes and systems to maximize electronic lifecycle / maintenance submissions requirements, including a focus on continuous improvements
- Ensures submission and archival activities
- Qualifications
- Required:
- Knowledge of FDA/EMA/HC/Swiss Medic regulations and guidance for electronic and paper submissions
- Excellent knowledge and experience in regulatory operations, including: formatting, publishing, submitting, lifecycling, and archiving (eCTD) sequences
- Demonstrated performance in managing and producing time-intensive deliverables
- Expert knowledge of Document Management Systems (Documentum preferred) and publishing tools (e.g., DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, and ISIToolbox)
- Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and SharePoint