CMCレギュラトリーマネージャー/ CMC Regulatory Manager

An international regulatory services/CRO company is looking for a CMC Regulatory Representative – Manager. The selected candidate will develop and implement CMC regulatory strategies. This is a long-term haken and remote setup position.

Responsibilities:

• Develop and implement CMC regulatory strategies for pharmaceutical products
• Lead the preparation and submission of CMC dossiers
• Serve as the CMC Product Lead for assigned products
• Aid in developing and executing global product and project regulatory strategies
• Collaborate with clients and external partners to support change management
• Manage execution of CMC documentation for post-approval changes
• Assess and communicate potential regulatory risks and propose mitigation strategies
• Deliver regulatory milestones and communicate potential regulatory issues

Requirements:

• Bachelor’s degree or above in life sciences, health sciences, or pharmaceutical sciences
• 12-15 years of relevant CMC pre/post approval experience
• Strong experience in CMC requirements
• Proven experience in critically reviewing detailed scientific information
• Effective leadership and interpersonal communication skills
• Native level Japanese; proficient in English

About the Company:

A leading company in regulatory services and clinical research, known for its innovative solutions and commitment to excellence. With a strong global presence, the company focuses on providing top-tier regulatory support to the pharmaceutical industry.

Keywords:

CMC規制, 製薬, 申請書類, 規制戦略, 規制当局, 品質保証, 変更管理, チーム管理, 求人, 外資系

2055310/001