Regulatory Affairs Specialist

About This Role

This specialist role in Regulatory Affairs manages the licensing process for Roche's diagnostic products, ensuring patient access to essential tests. It involves close collaboration with internal and external stakeholders to develop and execute regulatory strategies and maintain approvals for in vitro diagnostics and medical devices.

Responsibilities

• Develop rational regulatory introduction strategies in collaboration with product introduction departments (Global Regulatory Team, business teams, etc.)
• Execute and obtain manufacturing and sales approvals for in vitro diagnostics and medical devices (including program medical devices), and maintain those approvals, through PMDA consultations and negotiations with administrative officials (MHLW, PMDA) and global representatives
• Perform in-house regulatory tasks (change management, review of packaging materials and various documents, etc.)

Requirements

• Experience expanding responsibilities with years of experience, and autonomously and proactively advancing tasks to achieve results
• Experience in regulatory application work for in vitro diagnostics or medical devices (around 3 years of experience is welcome)
• General knowledge of pharmaceutical affairs laws and regulations
• Degree in biochemistry, biology, immunology, microbiology, engineering, agriculture, or pharmacology (or equivalent or higher)
• Knowledge of biochemistry, immunology, genetics, pathological tests, and program medical devices is a plus
• Ability to interpret scientific and technical papers and data in biochemistry, biology, immunology, microbiology, engineering, agriculture, or pharmacology
• Essential English reading and writing skills
• Conversational English skills (business level is a plus)
• Logical thinking and writing composition skills
• Ownership to autonomously and proactively advance tasks/projects, regardless of job grade, not limited to daily operations
• Communication and coordination skills with related departments
• Passion as a regulatory specialist
• Overall optimization perspective to consider exit strategies for product launch from the viewpoint of a regulatory specialist, in addition to an HCE division and company-wide perspective
• Execution ability to correctly understand one's role and pursue results from that perspective

Benefits

• Annual bonus (March)
• Annual salary increase (April)
• Housing allowance
• Sales allowance
• Field allowance
• Overtime, holiday, and late-night work allowance
• Commuting allowance
• Separation allowance
• Annual paid leave (statutory days plus company-specific days)