[Innovative Medicine] R&D, Specialist/Manager, Regulatory Strategy & Liaison Group, Regulatory Development, Regulatory Affairs (Pharmaceutical Regulatory Affairs)

Location: Chiyoda, Tokyo, Japan

Company

Johnson & Johnson MedTech develops healthcare solutions across Innovative Medicine and MedTech to help prevent, treat, and cure complex diseases.

What you will do

• Lead Japanese regulatory strategy and target labeling within cross-functional and global regulatory teams.
• Lead CTD preparation for Japanese NDA submissions and provide input on CTN submission plans and amendments.
• Plan and lead interactions with PMDA and MHLW, including consultations, preliminary meetings, and review responses.
• Prepare data-driven responses to Japanese health authority questions and manage regulatory submission commitments.
• Develop and revise Japanese target labels aligned with clinical, commercial, and regulatory strategies.
• Provide regulatory advice for product registration, maintenance, additional indications, and Japan-specific clinical development.

Requirements

• Bachelor’s degree or equivalent in pharmacy, life science, or a health-related discipline.
• At least 6 years of overall R&D experience in the pharmaceutical industry, including 2 or more years in regulatory affairs, or equivalent experience based on a master’s degree, PharmD, or PhD.
• Experience contributing to drug development strategies and interacting with health authorities.
• Knowledge of Japanese regulations and strong verbal and written communication skills in Japanese.
• Business-level English and the ability to collaborate effectively with global and cross-functional teams.
• Ability to accommodate early morning or evening meetings and teleconferences across time zones when required for Japan development plans.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and merit.
• Collaboration with Japan, global, and Asia-Pacific regulatory stakeholders.
• Opportunities to contribute to regulatory development, process improvements, and organizational initiatives.
• Flexible availability is required to support meetings across different time zones.