・部分変更申請(PAA)、承認前GMP/QMS査察、外国製造業者認定/登録(FMA/FMR)、製造販売承認(MA)届、軽微変更届(MCN)など、CMC関連の規制当局対応業務を監督し、主導する。
・担当製品のNDA/PAA/MCN などの申請資料を作成・レビューし、顧客ニーズおよび規制要件との整合を確保する。
・担当製品について包括的なリスクアセスメントを実施し、CMC戦略を策定する。チームと連携し、プロジェクト成功に向けて推進する。
・グローバル規制部門、製品サプライ部門、外部サプライヤー、規制当局などの関係者と効果的なコミュニケーションや折衝を行い、担当製品の承認取得を確実にする。信頼関係を構築し、オープンな対話と協働的な問題解決を促進する。
・経験の浅い同僚に対し、規制プロセス、変更評価、CMC規制戦略について助言し、専門性向上を支援する。
【求められる経験・スキル / Required Experience And Skills】
・CMC薬事としてのご経験(5年以上)
・中級レベルの英語力
【学歴】
大学卒業以上
【職種 / type of occupation】
薬事、メディカルライティング
【給与 / salary】
年収 800 〜 1,450万円
【賞与】
【雇用形態 / employment status】
正社員
雇用期間
期間の定めなし
試用期間
有り
【就業時間 / working hours】
09:00~18:00
【休日休暇 / holiday】
土曜日 日曜日 祝日
【保険 / social insurance】
健康保険 厚生年金保険 雇用保険
受動喫煙防止措置
敷地内禁煙
【特長 / features】
女性活躍中, 上場企業, 外資系企業, フレックスタイム制, 土日祝休み, グローバル人材歓迎
【業種 / industry】
医療機器・医療品関連
※詳細はお仕事のご紹介時にお伝えします
Job ID: VAC-285020/
Seniority Level: Mid-Senior level
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