[Hiring] Manager, Regulatory Operations @Otsuka Pharmaceutical Co., Ltd.

Role Description

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.

As an integral member of Otsuka’s regulatory operations team, the role includes:

• Providing regulatory publishing and submission assignments, monitoring, and oversight, as well as a lead or support for GRA efforts.
• Ensuring assigned submissions are made with quality, on-time, and within established budgets.
• Acting as primary liaison while coordinating regulatory publishing activities for all R&D functions.
• Liaising with affiliates for coordinating and publishing defined content.
• Owning 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.
• Designing and implementing processes and systems to maximize electronic lifecycle / maintenance submissions requirements, including a focus on continuous improvements.
• Ensuring submission and archival activities.
• Providing 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.
• Overseeing project team members for assigned submissions, including work assignments to vendor partners.
• Providing leadership and guidance for Process Mapping Teams (e.g., Key stakeholder for Regulatory Submissions, Key stakeholder for Annual Reports).
• Developing and maintaining assigned regulatory operations work instructions.
• Establishing and building collaborative relationships with colleagues.
• Organizing and maintaining regulatory files.
• Providing regulatory publishing guidance to other departments / functions.

Qualifications

• 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.

Requirements

• 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, accidental death & dismemberment insurance.
• Short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• A generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Other company provided benefits.