RGF is a global brand of RECRUIT Japan

Job Description

Company Overview

Job Description

•Collaborate with 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 HQ or overseas sites through overseas business trips or teleconference to prepare the strategic countermeasures on CMC relating matters.
•Support a manager of Biologics & Vaccine products group, check and review the status of group members’ tasks, and control resource.
•Lead, develop and coach younger group members.

•Eメ-ル、Word、Excel、Power Point、Acrobatについて、実務レベルの能力  


Required Qualifications:
•At least 5 years of Biologics or Vaccine products development experience in CMC Regulatory Affairs.
•Experienced in preparing PMDA consultation documents and dealing with issues.
•Experienced in preparing CTD and application form for approval, responding to inquiries on PMDA review and discussing with PMDA.
•Knowledge on CMC regulations (ICH Guidelines, Standards for biological materials, etc.) and basic knowledge on general pharmaceutical affairs (product life cycle management, etc.).
•Experience of commutation with overseas
•Master’s degree or above, in medicine, pharmacy, chemistry, or biology.
•Practical English speaking ability, presentation skills in English, and English documentation skills (TOEIC score 800 and over).
•Practical skills in E-mails, Word, Excel, Power Point, Acrobat.
•High level of compliance awareness.

Desired Qualifications:
•Experience of coaching/supervising group members as a manager or Leader
•Experience at CMC labs or pilot facility.