Job Description

Department:Regulatory CMC Japan

Report to:Head,Non-clinical & CMC Dev

1. Act as a key person to coordinate CMC and/or regulatory science issues between global and Japan so that appropriate solutions are provided
2. Be responsible for preparation of Appliation form, QOS and reviewing module 3 for Japan submission
3. Be responsible for preparation of answers to CMC inquiries from PMDA
4. Closely collaborate with global CMC regulatory for resposnible projects and initiatives.
5. Assess regulatory compliance of materials and their specifications (API, excipients and product) in advance for initiating Japan project
6. Actively provide key information of CMC regulatory guidelines to global counterpart so that appropriate CMC strategy is developed
7. Collect and share scientific, technical-related and specialized information from inside and outside resources and keep updated.
8. Identify critical scientific/technical issues well in advance to avoid or minimize the risk for development plan
9. Perform CMC regulatory assessment in change control process
10. Develop and expand active communication link within Japan/Global key stake holders to initiative good collaboration
11. Collaborate global business development regarding new licensing-in compounds on CMC area

Work experience

• 4-7 years or more experiences for CMC NDA dossier preparation (CTD module 2, module 3, and application form) and supplemental NDA (partial change, CTD module 2 and 3)
• Good professional experiences in CMC activities (e.g. formulation development, analytical development, API and DP manufacturing, CMC regulatory etc.)
• Knowledge of ICH guidelines and GMP, especially requirements for regulatory submissions
• Familiar to global pharmaceutical product development processes
• Business knowledge
• Familiar with IT application (word, excel, power point and other internal systems)

• English (intermediate or more) read, write, hearing and speaking

• Collaborative mindset

• Oriented in problem solving.