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Senior Regulatory Affairs Manager
年収：900万 ～ 1300万
採用企業案件
ギリアド・サイエンシズ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
| 部署・役職名 | Senior Regulatory Affairs Manager |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
• Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams. • With guidance, defines the regulatory strategy for one or more Gilead/Kite products or projects. • Evaluates changes to the local regulatory landscape and sharing risks and opportunities with the global study team when necessary. • Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plans. • Leads the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, original Clinical Trial Notification (CTN). • Leads cross-functional teams in the authoring of regulatory documents, including meeting requests, Module 1 documents for new drug submission, etc. • Provides input to the content of the original label and label updates. • Ensures product packaging and associated information is updated and maintained in accordance with the product license for assigned products and markets. • Contributes to process improvements and/or other special projects within Regulatory Affairs. • Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements. |
| 労働条件 | 正社員採用、試用期間あり |
| 応募資格 |
【必須（MUST）】 Minimum Education and Basic Qualifications:BA/ BS or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2026/03/06 |
| 求人番号 | 7684678 |
採用企業情報
- ギリアド・サイエンシズ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
-
会社概要
【設立】2012年11月
【代表者】ケネット・ブライスティング
【従業員数】799名（2024年7月現在）
【本社所在地】東京都千代田区丸の内1丁目9-2
【事業内容】医療用医薬品、再生医療等製品の製造・販売など
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です