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RA CMC & Quality Manager, Senior Manager

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Randstad

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Location:
Japan , Tokyo

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Category:

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Contract Type:
Not provided

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Salary:

10000000.00 - 15000000.00 JPY / Year
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Job Description:

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)
What we offer:
  • 労災保険
  • 日曜日,土曜日,祝日

Additional Information:

Job Posted:
January 12, 2026

Expiration:
January 15, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
Job Link Share:

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