Director, Regulatory Strategy

A global business consulting company is looking for a Director, Regulatory Strategy. The selected candidate will lead regulatory strategies for development-stage projects in Japan and coordinate cross-functional efforts.

Responsibilities:

• Lead regulatory strategy for development-stage projects in Japan
• Manage client interactions with PMDA including clinical trial notifications and consultations
• Act as project lead for Japan-specific regulatory initiatives
• Collaborate with global teams to align Japan regulatory requirements
• Review and adapt English regulatory documents for Japanese submission
• Oversee coordination with local consultants and vendors

Requirements:

• 10-15 years of experience in regulatory affairs or drug development
• Experience with PMDA interactions (clinical development and submission planning)
• Prior experience supporting projects from early development to market approval
• Proven experience in a consultancy, CRO, or global sponsor environment is ideal
• Background in therapeutic area is a plus
• Fluent level written and verbal Japanese and English

About the Company:

A multinational company providing regulatory compliance, pharmacovigilance and medical information services around the world. The team of experts is committed to providing the highest quality support services in the healthcare industry.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: 2RERJW