グローバル研究開発本部 薬事領域 CMC薬事部 化成品担当サイエンティスト
MSD
Urban Ace, Osaka, Japan
3 日前

Job Description

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.
  • 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.
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