Job Description

社名
社名非公開

職種
薬事、メディカルライティング

業務内容
Lead CMC regulatory strategies and quality management for a global pharmaceutical leader in Japan – a dynamic role offering significant impact and growth potential.■About the companyOur client is a well-established and respected global pharmaceutical company with a strong presence in Japan. They are committed to developing and delivering innovative therapies to patients worldwide and fostering a collaborative and supportive work environment.■Role & ResponsibilitiesAs the RA CMC & Quality Manager, you will play a pivotal role in ensuring the regulatory compliance and high quality of our client's biologics. You will lead CMC regulatory strategies across the product lifecycle, from initial development to post-market surveillance, and act as the Qualified Person in Japan, ensuring adherence to all local regulations. You'll collaborate closely with cross-functional teams (R&D, Project Management, Manufacturing, Quality, and Regulatory) to develop and implement robust CMC strategies for timely and high-quality submissions. This involves hands-on participation in submission preparation and close interaction with Japanese regulatory agencies.■Main tasks include・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.If you are interested in this exciting opportunity, apply now.We look forward to hearing from you.#LI-Hybrid#LI-KN

求められる経験
■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).

保険
労災保険

休日休暇
日曜日,土曜日,祝日

給与
年収1,000 ～ 1,500万円

賞与
-
雇用期間
期間の定めなし

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