CMC-RA manager

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MAIN FOCUS AND MISSION:

・Lead and manage CMC regulatory activities including relevant cross-functional communication, providing guidance across the product lifecycle, and ensuring timely regulatory compliance with official guidelines

・Develop and implement CMC registration strategies related to CTNs, NDAs, Partial changes, Minor changes, and Regulatory consultations

・Support the development of CMCRA team

ROLE & RESPONSIBILITIES:

・Development of CMC Regulatory Strategy:

Collaborate with global CMC and related departments for pharmaceutical development projects to discuss and establish a CMC regulatory strategy aimed at fulfilling domestic CMC approval requirements and achieving rapid approval in Japan.

CMC薬事戦略の策定：
医薬品開発品目についてグローバルCMC等関連部署と連携し、本邦におけるCMC承認要件の実現かつ迅速な承認取得を目的としたCMC薬事戦略を協議・構築する。

・Domestic and International Coordination:

Under the global CMC plan, determine and execute domestic regulatory responses for new approval applications, partial change applications for marketed products, and minor change notifications. Negotiate with relevant departments, considering approval timing and impacts on global and domestic product supply.

国内外の対応

グローバル計画のもと、新規承認申請、市販製品の一部変更承認申請、軽微変更届における国内審査対応において、承認時期やグローバル及び国内市販品の供給への影響等を鑑み、関連部署と交渉を行い、国内の薬事対応を決定・遂行する。

・Preparation and Management of CMC Regulatory Application and Consultation Documents:

Practice the preparation and management of high-quality CMC approval application documents, supporting materials, and regulatory consultation documents.

CMC薬事関連申請資料・相談資料等の作成と管理：

高品質なCMC承認申請書類・添付資料・当局相談資料等の作成・管理を実践する。

・Liaison of CMC Regulatory Affairs:

Lead negotiations and respond to inquiries regarding CMC regulatory affairs with regulatory authorities (MHLW, PMDA, Tokyo Metropolitan Government).

行政対応：

規制当局（厚生労働省、PMDA、東京都庁）とのCMC薬事に関する折衝及び照会事項等対応をリードする。

・CMC Regulatory Intelligence Activities:

Strive to collect and understand CMC regulatory information. Regarding issues related to development products and launched products, conduct necessary discussions with relevant departments (including CMCRA personnel in each country) while considering the latest regulatory trends, and make proposals and recommendations.

CMC薬事インテリジェンス活動：

CMC薬事情報の収集・把握につとめ、開発品且つ既製品に係る課題につき、最新の規制動向を踏まえながら関連部署（各国CMCRA担当者含む）と必要な協議を行い、提案・提言を行う。

・Guide and support CMC Regulatory Affairs (RA) Specialists performing the above tasks、or hands-on if needed.

上記業務を担うCMC薬事スペシャリストを指導・サポートする、もしくは必要に応じ作業に直接加わる。

・Ohters:
 　その他

　　　　・Manage the creation and revision of packaging/labeling materials

　　　　　(e.g., package insert、artwork) in coordination with relevant departments.

　　関連部署と連携のもと、添付文書等包装・表示に係る資料の作成・改訂管理を行う。

　　　　・Handle administrative procedures and business management related to pharmaceutical 　　　　　Marketing approval holder’s license, as well as wholesale license.

　　医薬品製造販売業許可、医薬品卸売販売業許可に係る行政手続きと業態管理を行う。

YOUR PROFILE:

Advanced degree in medical, pharmaceutical or life-science, etc

（Bachelor‘s degree or higher）

学士以上（医学、薬学、理学 [生物科学] 等専攻）

Hard skills/ Expertise:

・Ideally + 10 years’ practical experience with CMC-related roles preferred (CMC regulatory affairs, Analytical/Quality testing, or Manufacturing) in Pharma Industry 

企業（製薬会社等）でのCMC関連（CMC薬事、分析・品質試験、もしくは製造）の実務経験（10年以上が望ましいい）

・Experience drafting and compiling regulatory submissions for prescription drugs (including the Manufacturing and Specifications section of CTD Module 1.2, and creating Japanese versions of CTD Module 2.3 from English source documents) and regulatory (PMDA) consultation materials within the past 5 to 6 years preferred

医療用医薬品の承認申請書類（同申請書の製造方法又は規格及び試験方法欄、英語の基資料からCTD Module 2.3など日本語版の作成含む）及びPMDA相談資料の執筆・編纂経験あり（過去５-6年以内が望ましい）

・Practical experience in any of the following regulatory affairs-related tasks: business licensing, foreign manufacturer certification, Drug Master File, GMP compliance inspections, etc.

薬制薬事等関連業務、例えば業許可、外国製造業者認定、ドラッグマスターファイル、GMP適合性調査等、いずれかの実務経験あり

・Knowledge of CMC-related regulatory regulations, including guidelines/notices for pharmaceutical active ingredients and formulations, and the Japanese Pharcopoeia

医薬品原薬・製剤に関する各種ガイドライン・通知や日局等、CMCに係る薬事規制に関する知識

・Good level of in English (business presentation, email, Web meeting)

ビジネスレベルの英語力（プレゼンテーション、eメール、Web会議）

Soft skills:

・Team work

・Experience of People management

Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.

At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.