CMCエキスパート/ CMC Expert

A multinational pharmaceutical company is looking for a CMC Expert (chemistry, manufacturing, and controls). The selected candidate will lead regulatory strategies, ensure high-quality submissions, and support global CMC activities to drive innovation in drug development.

Responsibilities:

• Prepare J-QOS documents, application sheets, and responses to PMDA/MHLW inquiries in collaboration with HQ
• Collaborate with HQ on regulatory strategy and scientific considerations for CMC applications
• Review and perform quality control of M3 documents, J-QOS, and application materials prepared by HQ and local experts
• Share Japanese regulatory insights and knowledge from other drug development projects with global CMC teams
• Engage with regulatory authorities, external experts, and internal departments
• Coach CMC associates and RA staff to enhance professional skills and regulatory knowledge

Requirements:

• Bachelor’s degree or above in medical science or chemistry
• More than 5 years of experience in drug development
• Skilled in regulatory compliance, drug development processes, and documentation
• Business level English; fluent Japanese

Preferred requirements:

• Experience in regulatory CMC and involvement in the approval of multiple product applications

About the Company:

An international pharmaceutical group, this company produces a range of products for a variety of ailments. Renowned for its sustainability, this organisation has been recognised for the high quality of its work environment.

Keywords:

規制戦略, 薬事申請, 医薬品開発, 品質管理, 求人, 外資系

Job Ref: IE5P2F