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.