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部署・役職名 | R&D Regulatory Affairs Group Manager - Specialty Care |
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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 a 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 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 submissions (e.g. J-NDA and J-sNDA), and/or any type of responses document to Health Authority questions with the stakeholders (Nonclinical, clinical, Medical, Pharmacovigilance, etc.), Ensure maintenance and compliance of regulatory activities for the 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. |
労働条件 |
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 Knowledge And Skills Desirable But Not Essential: Knowledge about the recent regulation Oncology regulatory experience and knowledge Network in the Regulatory field/Pharmaceutical industries |
応募資格 |
【必須(MUST)】 Strategy focus and clear/courageous mindsetMutual respect through open communication and well-stakeholder management Knowledge /experience of regulatory submission and approval. Experience in people management (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 in pharmaceuticals or science Experience in regulatory activities, including interaction with PMDA/MHLW in RA organization 【歓迎(WANT)】 Knowledge about the recent regulationOncology regulatory experience and knowledge Network in the Regulatory field/Pharmaceutical industries |
リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
受動喫煙対策 | 屋内禁煙 |
更新日 | 2023/03/03 |
求人番号 | 2627922 |
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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