Join a global European life sciences company as a Senior Regulatory Affairs Manager, leading Japan's regulatory strategy and overseeing submissions for new drug applications. In this high-impact role, you will be the primary representative for interactions with Japanese health authorities, guide regulatory planning, and support both pre-approval and post-marketing activities. You will also mentor junior staff and collaborate with global teams to ensure compliant and timely regulatory outcomes across Japan's pharmaceutical portfolio.
Key Responsibilities
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Lead communications with Japanese health authorities, including PMDA and related agencies
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Manage regulatory strategy and submission plans for new drug applications in Japan
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Oversee the full approval process for NDAs and support post-approval lifecycle management
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Lead regulatory changes for already approved products
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Ensure compliance of drug labels, promotional materials, and documentation
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Mentor and develop junior regulatory team members
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Improve internal regulatory processes and manage external vendors as needed
Required Skills and Qualifications
Experience:
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Strong experience in regulatory affairs for drug development or post-marketing
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Ability to collaborate with cross-functional teams in Japan and globally
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Proven leadership skills with the ability to manage key stakeholders
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Experience managing regulatory risks for complex pharmaceutical projects
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Fluent Japanese and business-level English communication skills
Soft Skills:
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Strong leadership for stakeholder management and team mentoring
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Excellent communication for health authority negotiations and global discussions
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Strategic thinking to develop regulatory plans and identify risks
Language Requirements:
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Japanese: Native
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English: Business level
Preferred Skills & Qualifications
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Experience leading high-level regulatory strategy for new drug submissions
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Knowledge of Japan's regulatory landscape and PMDA processes
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Experience managing regulatory vendors and internal process improvement
About the Company
Our client is a global European life sciences leader providing essential tools, chemicals, and scientific services to researchers, academic institutions, and pharmaceutical companies. Their solutions support the discovery, development, and manufacturing of new medicines, while also offering testing products that safeguard food and water safety worldwide.
Why You'll Love Working Here
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Senior strategic role leading new drug submissions in Japan
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Act as the key representative in discussions with Japanese health agencies
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Opportunity to mentor regulatory team members and shape organizational processes
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Work closely with global teams on high-impact regulatory initiatives
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Contribute to innovation in a highly respected international life sciences organization
Don't Miss Out - Apply Now!
