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R&D Regulatory Affairs Manager - Specialty care

年収:800万 ~ 1200万

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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

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