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Lead CMC regulatory strategies and quality management for a global pharmaceutical leader in Japan – a dynamic role offering significant impact and growth potential.
Job Responsibility:
Lead CMC regulatory strategies for global regulatory activities for innovative biologics
Manage interactions with PMDA to ensure acceptance and rapid review of submissions
Maintain in-depth understanding of company compounds, manufacturing aspects, and specifications
Prepare and review CMC sections of global submissions (DMFs, INDs, CTAs, NDAs, BLAs, MAAs, IDEs, PMAs, etc.)
Evaluate proposed manufacturing changes and provide strategic guidance
Support CMC QA functions (e.g., deviations, GMP/regulatory issues)
Maintain knowledge of the global regulatory environment and advise project teams
Implement and maintain product quality management systems (QMS) for GMP/GDP in Japan
Ensure proper product release to the market and handle complaints/recalls
Establish quality agreements with contract warehouses and service providers
Requirements:
Bachelor's degree in pharmacy, microbiology, biotechnology, chemistry, or a related scientific discipline
Minimum eight (8) years’ experience in the Pharmaceutical Industry with direct experience with biologic technical functions
Minimum five (5) years’ experience in Regulatory CMC supporting global programs
Minimum three (3) years’ experience in quality management within the Japanese pharmaceutical industry as a MAH
Technical knowledge of Biologics CMC, GQP, GMP, and pharmaceutical-related laws and regulations in Japan
Proven success in global submission filing, approval, and lifecycle management
Fluent English and Japanese communication skills (written and spoken)