Our client is a leading multinational pharmaceutical company and is looking for a strong Regulatory Affairs Director for their growing organization in Japan. The company has an exciting coverage of several therapeutic areas and a solid pipeline of products to be launched in the next few years.
The Regulatory Affairs Director will take overall responsibility for leading the team and driving the regulatory strategy and submissions as well as evaluate risk assessment in Japan, as part of the Asia Pacific Region, and Global.
In addition will:
• Propose/development, implement, review and update the regulatory affairs strategy plan and supervise the team
• Review and approve registration dossier and other regulatory documents
• Manage overall progress of projects
• Represent Regulatory Affairs on various cross-function teams
• Serve as the primary interface with MHLW and PMDA for product approval and development of projects in Japan
• Serve as the primary interface with Global Regulatory Affairs
The qualified candidate will have:
• A degree in Life Science or pharmacy
• 10-15 years’ experience in Regulatory Affairs in the pharmaceutical industry in Japan
• Proven track record of preparing successful Japanese regulatory submissions
• Fluency in Japanese and English
The company offers highly competitive salary and benefits package as well as career growth opportunities.