Regulatory Affairs Manager

Our corporate activities are growing rapidly, and we are currently seeking a full-time, Regulatory Affairs Manager to be based in Tokyo, Japan. This person will be a key member of Regulatory Affairs project teams to accomplish tasks and projects that are instrumental to the company’s success. With this opportunity, you will be able to leverage previous expertise and continue to develop and grow your career even further within the drug development industry.

• Support portfolio management for Sponsors
• Partner with cross-functional teams to execute Sponsor programs
• Engage in the preparation and maintenance of regulatory submissions and files
• Coordinate project start-up activities, track and report project status, and maintain project documentation such as communication plans, submission timelines, and task orders/scopes of work
• Serve as the primary point of contact for Sponsors and regulatory authorities
• Maintain comprehensive project timelines including projects with multiple regulatory submissions
• Schedule and lead internal and external project team meetings
• Work closely with other Regulatory Affairs project team members such as Regulatory Strategy Leads, Regulatory Science Managers, Medical Writers, and Regulatory Document Specialists to execute project plans
• Maintain clear and effective Sponsor communication, identify and anticipate possible issues and/or challenges, and work with the project team to develop solutions
• Liaise with Clinical Safety to ensure adverse events are reported to Regulatory Agencies in accurate and timely fashion
• Attend clinical operations internal meetings as the Regulatory Affairs representative
• Track, compile, and maintain full regulatory applications
• Maintain timelines for full regulatory documents
• Coordinate interactions and timelines with outside vendors regarding regulatory documents
• Provide regulatory advice and guidance to Clinical Operations, Medical Writing, Clinical Safety/Pharmacovigilance, Data Management, and Biostatistics to ensure compliance with appropriate national/regional government regulations and requirements (including review of protocols, drug development plans, study reports, and marketing application components)
• Interact with appropriate national/regional government regulatory agencies
• Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges

• Bachelor’s Degree in life sciences required; Master’s Degree preferred
• ³5 years of biopharma or CRO regulatory affairs experience
• Demonstrate ability to independently track, compile, and maintain full regulatory applications to ensure compliance with governing regulations and guidance
• Demonstrated ability to interact with appropriate national/regional government regulatory agencies
• Demonstrated ability to write departmental Standard Operating Procedures.
• Bilingual Japanese and English