Senior Manager, Regulatory Operations

## Senior Manager, Regulatory Operations Apply locations:
Princeton, NJtime type:
Full time posted on:
Posted Yesterday job requisition :
R12288
* ** 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
* ** 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, 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 SharePoint  + 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  
** Preferred**  + 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
** Competencies*
* ** Accountability for Results
- ** Stay focused on key strategic objectives, be accountable for high standards of…