The 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
- 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
- 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
- Knowledge in developing processes across multiple departments/divisions that leverage technology
- Recent experience with NDAs / MAAs is essential
- Minimum of 5 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 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
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.Valid Proof of COVID-19 Vaccination or Accommodation
The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.Statement Regarding Job Recruiting Fraud Scams
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Please understand, Otsuka will never
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