1.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
2.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
3.Maintain the contents in various databases to share Japan status on marketed products precisely and transparently with all the stakeholders
4.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
5.Support divestment and pruning activities and third party customers for marketed products in line with business strategy 6.Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
7.100% timely delivery of all training requirements including compliance.
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.
Real Staffingについてもっと詳しく知りたい方はこちらへ→ www.apac.realstaffing.com/ja