Job DescriptionCMC Regulatory Affairs (RA) tasks from initial stage of new drug development to NDA filing and the approval, addition of dosage form, and change controls
• Collaborate with our HQ CMC RA members to appropriately advance the CMC development stage of the project in charge, and prepare CTD CMC parts (i.e. Manufacturing method, Specifications and test methods, and Stability) logically with high scientific quality.
• Identify product issues and assess risks from the CMC viewpoint, and plan countermeasures.
• Provide CMC-RA information obtained from regulatory authorities or industry associations to Japan/overseas relevant divisions, and discuss with them.
• Evaluate CMC related changes and take appropriate RA action, if necessary.
• Appropriately respond to questions from the authorities on consultations or on review for approval, or negotiate if necessary.
• Cooperate with our HQ or overseas sites through overseas business trips or teleconference to prepare the strategic countermeasures on CMC relating matters.
Requirements• Experience at CMC labs or pilot facility of Drug Substances/Drug Products, or Analyses, or CMC Regulatory Affairs.
• Master’s degree or above, in medicine, pharmacy, chemistry, or biology.
• Practical English speaking ability (TOEIC score 730 and over）.
• Practical skills in E-mails, Word, Excel, Power Point, Acrobat.
• High level of compliance awareness.
• A person cooperative, voluntary motivated, and patiently challenge the issues toward solution.
• Experience of commutation with overseas