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Regulatory Labeling Manager（薬事）
年収：900万 ～ 1400万
採用企業案件
サノフィ株式会社
-
- 資本金500百万円
- 会社規模501-5000人
- その他
- 医薬品メーカー
| 部署・役職名 | Regulatory Labeling Manager（薬事） |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Role & Responsibilities The Labeling Manager is responsible for the development, maintenance, and revision of Japan Prescribing Information as labeling for Japan (J-PI) for products. This role ensures compliance with relevant regulations and aligns with global labeling strategies. The Labeling Manager will develop strategies, prepare and submit PI drafts to the PMDA, and manage related data and information. Responsibilities of the role include management of processes, vendors, budgets, and stakeholders. Development and Maintenance of Prescribing Information for Japan (J-PI) Prepare and revise J-PI for the products with reasonable rationale based on strategies and sciences in accordance with relevant regulations: Develop strategy and J-PI ・Take actions related to requirements from the local Health Authorities (HA) ・Respond to Company Core Data Sheet (CCDS) updates ・Prepare J-PI drafts and submit to PMDA with related materials such as CCDS and SER ・Respond to PMDA’s inquiries ・Handle J-PI notification ・Manage data and information related to J-PI revision using system tools ・Transfer PI-related information during business succession ・Manage PI-related information for pruning products ・Follow up on e-labeling implementation ・Consult with PMDA for “New format” revision drafts PI-related Materials ・Create, consult with PMDA for, and revise PI-related materials for marketed products such as Medication Guides for Patients Management of Processes, Vendors, Budgets, and Stakeholders ・Ensure timely and efficient management of labeling operations and related vendors ・Monitor labeling budgets and collaborate with relevant departments ・Engage stakeholders across functions to support labeling processes Activities Related to Safety Measures ・Participate in Drug Safety Committee (DSC) led by Pharmacovigilance ・Support GVP inspections Building Cooperative Relations with Internal Functional Groups ・Provide information on creation or revision of J-PI to Manufacturing & Supply in a timely manner ・Maintain good relationships with Medical Affairs to ensure scientific consistency in materials ・Actively participate in key meetings such as Product Management Review Meeting as a regulatory representative Global Labeling ・Align with Global Labeling group for J-PI through close communication ・Contribute to Global Labeling initiatives such as end-to-end (E2E) labeling Knowledge, Skills & Competencies / Language ・Good working knowledge in development and post-marketing regulatory processes ・Strong negotiation skills for discussion with cross-functional stakeholders ・Ability to build strong relationships with relevant functions ・Demonstrated knowledge of regulatory requirements and/or guidance ・Good communication skills, both verbal and written, in Japanese and English ・Familiarity with labeling-related global regulatory requirements (e.g., US and EU) Qualifications ・Business-level English proficiency (e.g., TOEIC score of 850 or above) ・Experience in regulatory affairs |
| 応募資格 |
【必須（MUST）】 ・Business-level English proficiency (e.g., TOEIC score of 850 or above)・Experience in regulatory affairs 【歓迎（WANT）】 【必須（MAST）】と同様に、以下の応募資格を満たす方を歓迎いたします・Business-level English proficiency (e.g., TOEIC score of 850 or above) ・Experience in regulatory affairs |
| アピールポイント | 自社サービス・製品あり 外資系企業 女性管理職実績あり 従業員数1000人以上 シェアトップクラス 年間休日120日以上 産休・育休取得実績あり 教育・研修制度充実 |
| 受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2025/04/22 |
| 求人番号 | 4571030 |
採用企業情報
- サノフィ株式会社
-
- 資本金500百万円
- 会社規模501-5000人
- その他
- 医薬品メーカー
-
会社概要
【設立】2006年1月1日
【代表者】代表取締役社長 岩屋 孝彦
【資本金】5億円
【売上高】2,058億円（2023年）
【従業員数】1,970人（2024年3月現在）*サノフィ・ジャパングループ 全体
【本社所在地】東京都新宿区西新宿三丁目20番2号
【その他事業所】物流センター（埼玉県三郷市、大阪府茨木市）
【事業内容】医薬品等の製造販売・輸入、研究開発
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