Senior Manager, Regulatory Operations

Job Summary 

The Sr. Mgr Regulatory Operations is responsible for the coordination of high quality and on-time regulatory publishing deliverables in line with the strategic direction of their assigned programs/products, identifies impact of agency guidance updates relevant to submission process, and drives innovative process change for improved efficiency. 

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
• Collaborates with alliance partners to achieve corporate objectives for shared dossier development, submission, and archival activities
• Supervises staff to assure quality control checks of documents intended for submission to regulatory agencies and compliance with electronic regulatory standards 
• Oversees project team members for assigned submissions, including work assignments to vendor partners 
• Provides leadership and guidance for Process Mapping Teams (e.g., Key stakeholder for Regulatory Submissions, Key stakeholder for Annual Reports) 
• Develops and maintains assigned regulatory operations work instructions 
• Establishes and builds collaborative relationships with colleagues 
• Responsible for organizing and maintaining regulatory files 
• Provides regulatory publishing guidance to other departments / functions