Regulatory Strategy & Liaison Specialist/Manager

About the role

Johnson & Johnson seeks an experienced regulatory professional to lead Japanese regulatory strategy, target labeling, and submission activities for innovative medicines. The role will coordinate with global teams and Japanese health authorities to ensure alignment with the overall product development plan.

Key responsibilities

• Define and lead Japanese regulatory strategy, target labeling, and CTD preparation for J‑NDA submissions.
• Manage interactions with PMDA, MHLW and other Japanese health authorities, including consultations, meetings, and 30/14‑day reviews.
• Provide regulatory input to global teams, support clinical study design for Japan, and maintain contingency plans.
• Lead the Japanese Labeling Working Group, draft disease‑specific target labels, and ensure compliance with the regulatory strategy.
• Oversee lifecycle management submissions for new indications and amendments.

Required profile

• Minimum bachelor’s degree in pharmacy, life‑science or health‑related field (or advanced degree with relevant experience).
• At least 6 years of R&D experience in the pharmaceutical industry, including 2 years of regulatory experience.
• Proven experience leading drug development strategies and health‑authority interactions in Japan.
• Fluent in Japanese (verbal and written) and business‑level English.
• Strong analytical, communication and teamwork skills.

Required skills

• Regulatory strategy development for Japan
• CTD preparation and NDA/CTN submission
• Japanese health‑authority liaison (PMDA, MHLW)
• Japanese labeling and target product profile alignment