Associate Director or Director of Regulatory Compliance

Job Description :

General Description :

• Local Representative for Regulatory Affairs, Local Compliance
• Provide leadership and strategic direction for Regulatory Affairs and Compliance Communication in Japan, primarily in the post-marketing phase, with proactive input into commercial regulatory requirements during development.
• Act as an internal consultant on pharmaceutical regulations, including the PMD Act.
• Collect, analyze, and implement domestic pharmaceutical regulations; monitor and share regulatory trends (e.g., ICH, PIC / S, MHLW / PMDA).
• Promote regulatory awareness through internal briefings and materials on PMDA / MHLW updates and guidelines.
• Establish and maintain regulatory compliance systems, including SOPs, internal audits, and governance support.
• Oversee business license management (e.g., MAH, manufacturer) and collaborate with GQP / GVP departments.
• Package Insert (labeling) maintenance for commercial products
• Support the Three Key Roles under the PMD Act (General Marketing, Safety, and Quality Compliance Officers).
• Lead and prepare for inspections by regulatory authorities, including the Tokyo Metropolitan Government.
• Manage GMP inspections (pre-approval, periodic) and foreign manufacturer accreditation with CMC Regulatory and Quality.
• Handle PMDA / MHLW interactions for commercial products, including consultations, inquiries, and GMP / CMC variation responses.
• Lead and coordinate CMC variation submissions with global and local CMC Regulatory teams.
• Collaborate with global regulatory counterparts to align regional and global strategies.
• Coordinate with internal teams (e.g., Development, QA, Safety, Manufacturing, Marketing, Medical Affairs) and external stakeholders (e.g., industry associations, academic societies).
• Support Japan-specific regulatory requirements such as RMPs, re-examination applications, and post-marketing surveillance.
• Maintain package inserts and review promotional materials for regulatory compliance.

Qualification Required :

Education Required :

Bachelor degree and / or Master Degree in Pharmacy or life science.

Other Qualifications :

Computer Skills :

Travel : up to 10%

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