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| 部署・役職名 | R＆D Regulatory Affairs Manager － Specialty care |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Roles & Responsibilities The R&D Regulatory Affairs has responsibility for managing products under development and/or marketed products with new indications/dosages. · Develop regulatory strategy for new drug developments, Health Authority meetings and Japan New Drug Submission (J-NDA) and provide regulatory expertise within project/product teams for products under development and/or marketed products, · Prepare Japanese Common Technical Documents (J-CTD) for the regulatory submission and arrange the internal review of J-CTD, · Define, Coordinate and contribute to the preparation of Clinical Trial Notification (CTN), Health Authority meetings (e.g. PMDA Consultation Meetings) and major regulatory submission (e.g. J-NDA and J-sNDA) and/or any type of responses document to Health Authority questions with the stakeholders (Non clinical, clinical, Medical, Pharmacovigilance, etc.), · Ensure maintenance and compliance of regulatory activities for development and marketed products, · Be a communication hub between Australia/South Korea and Global as the JPAC representative, · Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy. · Coordinate Japanese Package Insert Revision activities on Commercial and Medical Division’s request that is covered by PMDA New Drug Review Division. |
| 応募資格 |
【必須（MUST）】 Knowledge And Skills:Leadership skill with Play to win behaviors · Strategy focus and clear/courageous mindset · Mutual respect by the open communication and well-stakeholder management · Knowledge /experience of regulatory submission and approval. · Experience of people leader (including coaching/mentoring) and great passion for the people development · Respect others with DE&I mindset · English communication skill Formal Education And/Or Experience Required: · Bachelorship of pharmaceuticals or science · Experience of regulatory activities, including interaction with PMDA/MHLW in RA organization 【歓迎（WANT）】 Knowledge And Skills Desirable But Not Essential:· Knowledge about the recent regulation · Oncology regulatory experience and knowledge · Network in the Regulatory field/Pharmaceutical industries |
| 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 | 屋内禁煙 |
| 更新日 | 2023/02/20 |
| 求人番号 | 2608549 |
採用企業情報
- 採用企業名は会員のみ表示されます
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- 資本金500百万円
- 会社規模501-5000人
- その他
- 医薬品メーカー
