Regulatory Operations Sr. Project Manager, 規制提出プロジェクトマネージャー
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Job Description
Regulatory Operations Sr. Project Manager leading regulatory submission projects for Parexel. Ensure high-quality submissions to authorities within deadlines with collaboration across teams.
Responsibilities:
- 規制提出プロジェクトの計画策定、タイムライン管理、および進捗管理
- クロスファンクショナルチームとの連携による提出戦略・責任分担の明確化
- 提出ドキュメントの品質・整合性確保および課題解決
- 規制出版部門および外部ベンダーとの連携による提出成果物の管理と進行調整
- 提出内容のレビューおよび各国規制ガイドラインへの準拠確認
- PMDA相談、臨床試験通知、変更申請、軽微変更届、承認申請の提出支援
- 提出テンプレートおよび標準プロセスの維持・改善
- 規制提出における標準化・一貫性の推進
- EDMS(電子文書管理システム)内の文書およびメタデータ管理
Requirements:
- 学士号以上
- 製薬業界における6年以上の関連経験(Regulatory Affairs / Submission / Operations)
- 規制提出プロセスおよびeCTDガイドラインに関する深い知識
- プロジェクトマネジメントおよびスケジュール管理スキル
- Veeva Vault RIM、docuBridge等の提出関連システムの使用経験
- eCTD作成および検証プロセスの実務経験
- MS OfficeおよびAdobe Acrobatの高い操作スキル
- 日本語:ネイティブレベル
- 英語:ビジネスレベル(読み書き+会議対応)
Benefits:
- フルリモート
- 健康保険
- 年次有給休暇
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