Job opening - Regulatory Affairs Associate Director：製薬企業 in 東京23区 | Randstad

summary

東京23区, 東京都
¥10,000,000 - ¥17,000,000 per year, 年収1,000 ～ 1,700万円
permanent

job category
biotechnology & pharmaceutical

job details

社名
社名非公開

職種
薬事、メディカルライティング

業務内容 ...

• Serving as a contact point for the company, coordinates for pharmaceutical affairs matters on product development between internal concerned departments and regulatory authority.• Performs pharmaceutical regulatory affairs tasks for obtaining pharmaceutical product approval.• Prepares various pharmaceutical regulatory affairs documents in a timely and appropriate manner according to the product development plan.• Manages pharmaceutical regulatory affairs schedules for product development plan.• Working with internal concerned departments, prepares appendices attached to pharmaceutical regulatory affairs documents to be submitted to regulatory authority and submits them.• Negotiates with subcontractors and external parties about pharmaceutical affairs issues as needed.• Working collaboratively with other departments, reviews the documents (minutes, examination report, etc.) created by regulatory authority, builds a consensus and confirm them with the regulatory authority and obtains the final version of the documents.• Presents pharmaceutical affairs strategies for product development plan to the concerned departments and gains consensus from them.• Support Director’s job

求められる経験
Regulatory Affairsとして承認申請の経験を有している方。(5年以上が望ましい。)

保険
健康保険,厚生年金保険,介護保険,雇用保険

休日休暇
日曜日,土曜日,祝日

給与
年収1,000 ～ 1,700万円

賞与
有

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社名
社名非公開

職種
薬事、メディカルライティング

業務内容
• Serving as a contact point for the company, coordinates for pharmaceutical affairs matters on product development between internal concerned departments and regulatory authority.• Performs pharmaceutical regulatory affairs tasks for obtaining pharmaceutical product approval.• Prepares various pharmaceutical regulatory affairs documents in a timely and appropriate manner according to the product development plan.• Manages pharmaceutical regulatory affairs schedules for product development plan.• Working with internal concerned departments, prepares appendices attached to pharmaceutical regulatory affairs documents to be submitted to regulatory authority and submits them.• Negotiates with subcontractors and external parties about pharmaceutical affairs issues as needed.• Working collaboratively with other departments, reviews the documents (minutes, examination report, etc.) created by regulatory authority, builds a consensus and confirm them with the regulatory authority and obtains the final version of the documents.• Presents pharmaceutical affairs strategies for product development plan to the concerned departments and gains consensus from them.• Support Director’s job ...

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experience
Regulatory Affairsとして承認申請の経験を有している方。(5年以上が望ましい。)

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posted 22 november 2024
社名社名非公開職種薬事、メディカルライティング業務内容Key Points about the Company:Strong pipeline in immunology, vaccines, rare diseases, and oncology, with several new products launching. It maintains a close relationship with its French headquarters, which prioritizes the Japan market. A leader in digitalization, it drives efficiency through data analysis and automation. Generous housing benefits include up to 80% subsidies and monthly homeowner allowances extended until retireme
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社名社名非公開職種営業(MR、MS、医療機器)、営業推進業務内容Develop and implement innovative training programs for a dynamic team in the pharmaceutical industry.■About the companyOur client is a leading pharmaceutical company dedicated to improving patient lives through cutting-edge treatments. They foster a collaborative and supportive environment, emphasizing continuous learning and professional growth.■Role & ResponsibilitiesIn this key role, you will design, develop, and deliver
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posted 19 november 2024
社名社名非公開職種薬事、メディカルライティング業務内容・NDA関連文書を作成し、リードライターとしてその品質管理を行う。・医薬品規制、標準操作手順書（SOP）、マニュアルなどに従い、高品質なNDA関連文書を作成する。・メディカルライティンググループの代表として、担当プロジェクトチーム（JPT）の意思決定に貢献する。・規制当局からの質問への回答文書やブリーフィングブックなど、規制文書の作成を通じて担当JPTを支援する。・担当プロジェクトのNDA関連文書作成に関する方針、スケジュール、予算などの戦略を立案し、JPTに提案する。・NDA関連文書の開発および維持のための適切な手順を準備する。・グローバルメディカルライティングの関係者と協力関係を構築する。・ベンダー管理に関する適切な手順を準備および更新する。・ベンダーとの調整を行い、NDA関連文書の作成を支援する。求められる経験▼Senior SpecialistTOEIC700点以上臨床開発、薬事、市販後調査の経験（メディカルライティングの経験を含む）5年以上また
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