Manager, Regulatory Operations

** Job Summary
** The Manager 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
* Provides direction to staff and contingent workers 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
** Qualifications
*
* Required:

* Minimum of 5 years of regulatory operations experience and in-depth first-hand experience with application electronic submissions
* 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  Preferred:
* Demonstrated performance in managing and producing quality time-intensive deliverables
* 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
** Competencies*
* ** Accountability for Results
- ** Stay focused on key strategic objectives,…