Job Title: Regulatory Affairs Manager

Summary of Job Description

The Regulatory Affairs Manager will be responsible for ensuring first-time approval of new products and new indications for existing products through participation in local brand teams as well as educating their staffs.

Major Responsibilities

• Develop local regulatory strategies and plans for major submissions to register New Chemical Entities (NCE) or new indications with the Director of Regulatory Affairs and agree on local submission timelines.
• Lead strategic discussions to accelerate development for Roadrunner projects. Based on the strategy developed, negotiate with regulatory authorities, and prepare for early submission.
• Lead new product labeling development to achieve a target product profile and post-marketing appropriate use of the product. Maintain and revise current labeling timely and appropriately in accordance with Global Company Core Data Sheets, complying with regulatory requirements, including GVP.
• Ensure Japan submission requirements are communicated to relevant regional and global regulatory teams.
• Determine local Regulatory Risk for submissions and risk mitigation strategies where relevant.
• Inform group managers of Regulatory Affairs and New Product Information (NPI) teams of progress of applications and issues impacting local applications.
• Assist with major submissions to register NCEs or new indications for existing products when needed.
• Maintain regulatory records for assigned product portfolios in compliance with local and global procedures.
• Manage interactions with PMDA and MHLW and maintain productive working relationships.
• Participate in/coordinate special project assignments as determined by the Director of Regulatory Affairs.
• Support the commercialization of products through participation in local NPI brand teams.
• Educate and train regulatory strategies to staffs.

Qualifications

• Essential Skills & Abilities:
• Ability and desire to create results.
• Requires excellent written and verbal communications in Japanese and business-level communications in English.
• Ability to effectively work under tight deadlines and manage projects independently.
• Resourcefulness in solving problems.
• Excellent people skills and an upbeat and enthusiastic attitude.

Education / Experience Required

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical-related fields is required.
• More than 5 years of related experience in regulatory affairs, including regulatory strategy and maintenance from CTN submissions to approvals of compounds. Experience in the area of neuroscience, eye care, or infectious disease is preferable.
• Must have pharmaceutical experience.

Estimated Salary: ¥20,000,000 - ¥25,000,000 per year