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R&D Regulatory Affairs Group Manager - Specialty Care

年収:800万 ~ 1300万

ヘッドハンター案件

部署・役職名 R&D Regulatory Affairs Group 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 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 mindset
Mutual 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 regulation
Oncology regulatory experience and knowledge
Network in the Regulatory field/Pharmaceutical industries

リモートワーク

「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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