Manager, Regulatory Operations
Otsuka Pharmaceutical Co., Ltd.
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
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, 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
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
Requirements
- Minimum of 5 years of regulatory operations experience
- 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
- Medical, Dental & Vision
- Prescription Drug Coverage
- Basic Life Insurance
- AD&D Insurance
- Short-Term Disability
- Long-Term Disability
- Tuition Reimbursement
- Student Loan Assistance
- 401(k) Matching
- Flexible Time Off
- Paid Holidays
- Paid Leave Programs
Company overview
Otsuka Pharmaceutical Co., Ltd. is a leading Japanese pharmaceutical company headquartered in Tokyo, Japan. Founded on August 10, 1964, the company operates as a wholly owned subsidiary of Otsuka Holdings Co., Ltd. With approximately 5,907 employees as of December 2024, Otsuka Pharmaceutical specializes in the research, development, manufacturing, and marketing of pharmaceutical products, clinical testing equipment, medical devices, food products, and cosmetics. The company has established a strong global presence with operations spanning multiple countries and regions. Otsuka is particularly known for its innovative approach to healthcare, focusing on both pharmaceutical treatments and nutraceutical products that support everyday health maintenance. The company's diverse portfolio includes well-known brands and has made significant contributions to various therapeutic areas, demonstrating its commitment to improving global health through scientific innovation and quality healthcare solutions.