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About Our Client
*All regional regulatory strategic and operational tasks for development products and/or established products from CMC point of view.
*Develops and executes regional CMC strategies, contributes to global CMC regulatory strategies/plans and closely cooperates with Japanese Health Authorities (HA) regarding regulatory dossiers submission, such as new applications and/or partial change application, for development products and/or established products with a view to obtain Japanese HA's approval in the fastest and most efficient way while ensuring compliance with the regional regulatory requirements.
*Preparation of CMC regulatory dossiers for development products and/or established products in accordance with Japanese regulations and requirements.
*Management of negotiations, meetings and consultations with Japanese HAs for development products and/or established products from CMC points of view.
*Interacts with Global Regulatory Leads (GRLs) and other Global Regulatory Affairs Strategy Team (GRAST) members to manage and resolve cross-functional issues.
The Successful Applicant
Preferably a post graduate degree in a life science or pharmacy
A minimum of 5 years of CMC experience for development products and/or established products, and regulatory activities such as new applications and partial change application. Experience with biological product is desired.
*Proficient in Japanese and English: speaking, listening and writing.
*Strong analytical skills and good judgment for implementing risk-based programs.
*Good communication and presentation skills.
*Good negotiation skills.
What's on Offer