Senior Regulatory Affairs Consultant

登録メンバーのみ 日本

1ヶ月前

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External Job Description · 職務内容: · プロジェクトリーダーの指示のもと、新薬開発段階での開発戦略及びCMC薬事戦略策定から製造販売承認申請及び承認取得後の製品の変更管理に関わるCMC薬事業務全般。また、クライントと協議、交渉を行う。 · パレクセルの業務遂行手順を順守する。 · クライアントに提出する成果物に、新たに習得した知識を効果的に反映させる。 · 業務内容 · プロジェクトにアサインされた後、クライアントと協同して、下記のコンサルテーションやCMC関連の薬事申請資料を作成サポートします。 · 薬剤開発におけるCMC ...
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