Reg CMC Manager | Japan

Job Position: Reg CMC Manager
Job Description: Shire – Tokyo – Local regulatory contact point for global team a. Contact Global Team to obtain necessary information of CMC topics pertaining to assigned projects b. Prepare project plans and timelines of approvals and planned submissions from the point of CMC Regulatory contact point for Japanese regulatory authorities and external regulatory experts c. Develop meeting materials and attend meetings with regulatory agencies d. Develop professional and effective working relationships with Japanese Regulatory Authorities and external CMC experts Japan-specific CMC-related data collection a. Plan and manage the batch analysis of the product batches and the stability studies in Japan, if necessary 1. Contract with third party laboratories 2. Manage the sample supply 3. Review and agree study protocol with Contract Laboratories 4. Have a PMDA reliability review of those raw data after NDA/PCA CMC related documentation for Japan market approvals,, GMP investigation , cycle management for LO…see more details

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