Regulatory Affairs Manager

Title: Regulatory Affairs Manager

Therapeutic Area: Neurology

Language:  Japanese / English Business at minimum

Visa:  Must hold valid Japanese working visa

Summary:

The Regulatory Affairs Manager is responsible for securing first-time approval of new products and new indications for existing products through active participation in local brand teams and by providing education to their staff.

Major Responsibilities:

• Develop Local Regulatory Strategies: Collaborate with the Director of Regulatory Affairs to create and plan major submissions for registering New Chemical Entities (NCE) or new indications, and agree on local submission timelines.
• Strategic Discussions: Lead strategic discussions to expedite development for Roadrunner projects, negotiate with regulatory authorities, and prepare for early submissions based on developed strategies.
• Product Labeling: Oversee the development of new product labeling to achieve the target product profile and ensure appropriate post-marketing use. Maintain and revise current labeling in a timely and appropriate manner, in accordance with the Global Company Core Data Sheet and regulatory requirements, including Good Pharmacovigilance Practices (GVP).
• Communication: Ensure Japan submission requirements are communicated to relevant regional and global regulatory teams.
• Risk Management: Assess local regulatory risks for submissions and develop risk mitigation strategies as necessary.
• Progress Reporting: Keep the Regulatory Affairs and New Product Information (NPI) team informed of application progress and any issues impacting local applications.
• Support Submissions: Assist with major submissions to register NCEs or new indications for existing products as needed.
• Regulatory Records Maintenance: Maintain regulatory records for the assigned product portfolio in compliance with local and global procedures.
• Regulatory Interactions: Manage interactions with the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW), maintaining productive working relationships.
• Special Projects: Participate in or coordinate special project assignments as determined by the Director of Regulatory Affairs.
• Commercialization Support: Support the commercialization of products through participation in local NPI brand teams.
• Staff Education and Training: Educate and train staff on regulatory strategy.

Qualifications:

Essential Skills & Abilities:

• Strong results-oriented mindset
• Excellent written and verbal communication skills in Japanese and business-level English
• Ability to work effectively under tight deadlines and manage projects independently
• Resourcefulness in problem-solving
• Exceptional people skills with an enthusiastic and positive attitude

Education / Experience Required:

• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical-related fields
• Over 5 years of experience in regulatory affairs, including regulatory strategy and maintenance, from Clinical Trial Notification (CTN) submission to compound approval. Experience in neuroscience, eye care, or infectious disease is preferable.
• Pharmaceutical industry experience is a must