Note: The job is a remote job and is open to candidates in USA. Otsuka Pharmaceutical Development and Commercialization, Inc. is seeking a Manager, Regulatory Operations to coordinate high-quality, timely regulatory publishing and submission deliverables. The role oversees electronic regulatory submissions, submission and archival activities, process improvements, regulatory operations staff and vendors, and collaboration across R&D functions and affiliates.
Responsibilities
- 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
Skills
- 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, 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
- 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
Benefits
- Comprehensive medical, dental, vision, prescription drug coverage
- Company provided basic life insurance
- Accidental death & dismemberment insurance
- Short-term and long-term disability insurance
- Tuition reimbursement
- Student loan assistance
- A generous 401(k) match
- Flexible time off
- Paid holidays
- Paid leave programs
- Other company provided benefits
Company Overview