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.

• 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

• 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, life cycling, 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., Docu Bridge, InSight Publisher, Global Submit Validate, Global Submit Review, and ISIToolbox)
• Strong computer skills with demonstrated experience and ability in Microsoft Office suite (Word, Excel, Access, and PowerPoint), and Share Point
• Knowledge in developing processes across multiple departments/divisions that leverage technology
• Recent experience with NDAs / MAAs is essential
• Minimum of 7 years of regulatory operations experience and in-depth first-hand experience with application electronic submissions

• Demonstrated performance in managing and producing quality time-intensive deliverables
• Strong influencing skills and experience with outsourcing
• Strong staff management skills
• Proven ability to solve complex issues through innovative problem solving
• Well defined written and oral communication skills
• Knowledge how/when to apply organizational policy or procedures to a variety of situations
• Demonstrated flexibility in dealing with change and diversity
• Ability to work effectively in a global, matrixed, multi-cultural, collaborative environment
• Successful engagement in multiple initiatives simultaneously
• Certification (such as Regulatory Affairs Professionals Society (RAPS))
• Prior project management experience

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful…