CMCRA specialist

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MAIN FOCUS AND MISSION:

・Responsible for the activity of Chemistry, Manufacturing & Control for development and  marketed products.

・With the Global RA CMC for development projects, ensure the CMC quality of the files in Japan.

・Liaises with the Global Manufacturing Team for marketed products ensuring that the appropriate Partial Change Applications (PCA) and Minor Change Notifications (MNC) are made on time in line with the global manufacturing change processes (for marketed products).

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:

Negotiate 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実施する。

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 + 5 years’ practical experience with CMC-related roles preferred (CMC regulatory affairs, CMC project lead, QA, Analytical/Quality testing, or Manufacturing) in Pharma Industry 

　企業（製薬会社等）でのCMC関連（CMC薬事、CMCプロジェクトリード、QA、分析・品質試験、もしくは製造）の実務経験（5年以上が望ましいい）

・Ideally + 3 years’ practical experience with CMC regulatory affairs related activity (exe. dossier preparation for submission like as, Application form related to CMC part and CTD module 2.3 etc.) in Pharma Industry. 

　企業（製薬会社等）でのCMC薬事申請関連業務(承認申請書 [CMCパート]やCTDモジュール2.3等の当局提出資料の作成など)の実務経験（3年以上が望ましい）

・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:

・A person who has a mindset of cross-functional teamwork

　組織内・組織間のメンバーと連携するチームワーク

・A person able to perform with growth mindset to difficult situations

　困難の状況におかれてもグロースマインドセットにて行動する

・A person able to propose themselves and respond flexibly from a CMC regulatory specialist point of view to achieve important milestones of drug development and registration

　医薬品開発・申請においてCMC薬事担当者としてフレキシブルな判断と適切な提案が自らできる

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.