RA CMC Group, Associates

Company Overview
◆グローバルランキング5位以内
◆ヨーロッパヘッドクオーター
◆癌、呼吸器、循環器、眼科領域を始め幅広い領域にパイプラインを持つ
◆癌領域に最先端の技術

Job Description
RA CMC Group, Associates

Job Purpose
Responsible for submission document preparation concerning CMC parts of NDA, PCA (Partial Change Application) and NMC (Notification of Minor Change) according to the agreed timelines to get the approval in Japan.
With regard to Marketed Products, responsible for regulatory evaluation for change requests generated at manufacture sites etc. based on Japanese guidelines and notifications.

Major Accountabilities
・ Contribute to TRD-Japan sub team for project development and submission
- Make the input into development strategy from regulatory CMC perspective
- Provide and/or manage CMC documents during project development
- Prepare submission documents (CTD document and Application Form) in line with the agreed timeline
- Prepare answer for PMDA inquiry working closely with relevant line functions Successful site opening for cell apheresis & cryopreservation.
・ Support Change Control Management for marketed product
- Provide accurate regulatory evaluation for change request generated at manufacture site and elaborate submission strategy and timeline with relevant line functions
- Prepare Application Form and necessary submission document in collaboration with global RA CMC and submit
- Manage communication with Japan Health authority and prepare quality answer for PMDA inquiry after PCA submission to get approval timely
・ Maintain the contents in various databases to share Japan status on marketed products precisely and transparently with all the stakeholders
・ Maintain latest CMC regulatory intelligence in Japan and inform global RA CMC and other relating members timely and appropriately. Ensure regulatory compliance for all RA CMC deliverables
・ Support divestment and pruning activities and third party customers for marketed products in line with business strategy
・ Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures
・ 100% timely delivery of all training requirements including compliance

Requirements
・ Education: Degree in pharmacy, science, agriculture, technical and pharmaceutical engineering discipline required and more advanced degree preferable.

・ Experience/Professional requirement:
- Experience in pharmaceutical industry.
- Possess basic technical, scientific and/or regulatory CMC knowledge in drug development and/or maintenance.
- Experience in interfacing with PMDA and MHLW regarding CMC area preferable.
- Experience in working in a global environment preferable.
- Address RA CMC related issues across relevant line functions and implement action plans.

・ Preferred experiences
- Experience of development, manufacturing, analytical testing and/or CMC regulatory for biologics products such as antibody drugs
- Experience and/or knowledge of development or manufacturing for regenerative medicine especially for cell and/or gene therapies

・ English Skill: Fluent English as business language

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