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- Job Description Summary We are seeking a highly motivated Regulatory Affairs Manager to lead regulatory strategies and ensure compliance for pharmaceutical and medical device products. This role plays a critical part in supporting produ...
- ...ary Responsible for supporting Associate Director Regulatory Affairs EMEA/Japan to ensure compliance with regulations and... ...oduct introductions. 35 Product Label & data management: Develop and review technical label copy based on...
- Senior Manger Regulatory Affairs, Tokyo, Home ICON plc is a world-leading healthcare intelligence and clinical research or... ...al development. We are currently seeking a Senior Manager, Regulatory Affairs to join our diverse and dynamic ...
- ...種 薬事、メディカルライティング 業務内容 Lead regulatory strategies and submissions for inno... ...u will lead cross-functional teams, manage submissions to the PMDA, and ensure... ...+ years of experience in regulatory affairs, with at least 3 years in IVD, gene...
- ...事戦略の提案やプレゼンテーション ・新規事業獲得にむけてクライアントへのアプローチ ・CMC 関連文書作成・CMC コンサルティング全般 ・業務関連通知・規制アップデートの全体共有 等 ※業務プロジェクトについては Manager と複数名のチームを組んで対応をいただくことを想定しています。 応募必要条件 職務経験 無し キャリアレベル ...
- .../ Objectives: The primary function of the Head of Regulatory Affairs in Japan is to act as the representative of the regu... ...on to the Japan affiliate, and is a member of AbbVie Management Team in Japan. The incumbent will ensure compliance ...
- Consumer RegulatoryAffairs Associate Manager (Senior Specialist) Division: Regulatory Affairs Johnson & Johnson Company PositionTitle: Associate Manager Position Summary Develop and flawlessly execute regulatorystrategies to th...
- ... 【求人No NJB2120680】 ・ PMDA 厚・労働省等の規制当局との面談・折衝 ・ 薬事分析（Regulatory Assessment）の実施 ・ Global PRA（欧州・アジア各国）およびクライアントとの協働 ... ...n】 ・ 開発薬事の担当 （当局対応、申請業務経験など）として、複数の業務経験。（臨床試験のProject Manager・臨床担当者として、当局対応や申請業務に携わった経験等も考慮） ・グローバル臨床試験に従事した経験 ・医...
- Job title: Senior Specialist, Regulatory Affairs 【業務内容】 Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation. Interacts ...
- Regulatory Affairs Specialist, Tokyo, Home ICON plc is a world-leading healthcare intelligence and clinical research organ... ..., renewals, and agency briefing documentation. ~ Managing and implementing label review, translation requireme...
- ...Job Description Summary Provides regulatory strategy and direction to the busin... ...lity with supervision by the direct manager or project leader. Report to direct... ...roject as an independent Regulatory Affairs professional is prefered. QA/Saf...
- 募集要項 【求人No NJB2250343】 RAスペシャリストとして、薬事申請（新製品の上市・既存品の変更）プロジェクトを推進して頂きます。 【職務概要】（泌尿器・外科治療製品） （ペリフェラルバスキュラー製品） ■新製品の市場投入および既存品の薬事承認に対する変更管理のための、薬事承認取得を加速的かつ確実に成功させるため、日本における包括的な薬事・臨床戦略の開発・推進・遂行に対するプロジェクトを管理し、薬事申請書類の作成と申請を実施する。 ■各行政機...
- ...ィカルライティング 業務内容 Lead strategic regulatory initiatives and grow your career wi... ...dscapes. You'll lead the regulatory affairs function and build strong relations... ...tegies for pharmaceutical devices.* Manage regulatory submissions and approval...
- 募集要項 【求人No NJB2314590】 医薬品の製造と品質管理に関する分野の薬事業務を担当いただきます。 医薬品の製造方法と品質試験方法に関する資料作成の経験を豊富に得ることが出来ます。 ＜業務例＞ ・マスターファイル（MF）の作成・登録と、登録後の変更対応 ・外国製造業者認定取得と認定後の変更対応 ・GMP適合性調査 ・CTD Module 2.3及び承認申請書の作成 ・PMDA相談資料の作成及び相談の実施 ・薬事規制の監視及...
- ...r Onsite Key Areas of Responsibility: Assesses regulatory intelligence to assist in the development of local reg... ...erred Knowledge / Competencies: Strong project management writing coordination and execution of regulatory items...
- .... Applies subject matter knowledge in the area of Regulatory Affairs. Requires capacity to apply skills/knowledge with... ...elopment and implementation regulatory strategy risk management chemistry manufacturing control (CMC). Ensures ti...
- Job title: Senior Specialist Regulatory Affairs Ensures rapid and timely approvals for respective product lines by plans on all product registration manage all product registrations preparation and documentation. Interacts with reg...
- At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world. ...
- ... performs specialized level work assignments and/or preparation and submission of documentation for the product regulatory registration ensuring products and procedures comply with regulatory agency specifications. Supports necessary ...
- Career Category Regulatory Job Description Group Purpose The Compliance and Labeling Group is responsible f... ...rials and meeting documentation. Excuse MAH license management and regulatory compliance activities in accordance wit...
- 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 希少疾患領域に強みを持つスペシャリティファーマです 小規模企業ながら、複数製品の承認取得を実現しております 1人当たりの職責は広く、ご経験を高めていただける環境です 求められる経験 ・理系学部卒業以上 ・10年以上の製薬業界でのご経験及び6年以上の薬事としてのご経験 ・新薬の申請から承認取得までの一貫したご経験 ・ビジネスレベルの英語力 保険 ...
- ...on along with the coordination and management of Government Agency visits. Evalu... ...ities / Duties ~ Supports Global Regulatory Services Team in leading the imple... ...~5 yrs Experience in JP regulatory affair product safety area (preferred) ~...
- Career Category Regulatory Job Description Group Purpose Japan Regulatory Affairs provides leadership expertise and execution for the regul... ... Organizational communication and time management skills needed to manage multiple assig...
- ...eam (region specific). Regional Regulatory Lead on Regulatory Project Teams. ... ... departments outside of Regulatory Affairs CMC for investigational and commer... ...mation to project teams and senior management in a timely manner. Initiates l...
- ...t we can achieve. At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - ...
- Job Description Are you ready to make a meaningful impact in Asset Management? Join a team where your expertise and ideas drive accuracy and innovation in regulatory reporting. You’ll collaborate with professionals across the business, ...
- ...スタイル リモートワーク・在宅勤務 募集要項 【業界】外資製薬 【雇用形態】派遣社員 【募集背景】増員 【就業開始時期】即日 【部署名】Regulatory Affairs RA担当 募集職種：RA担当（医療機器） 主な業務内容 １．以下の業務を外部コンサルタント会社と協業。外部コンサルタント会社の管理。申請資料編纂、申請のタイムライン管理、申請資料のレビュー、申請。 • 医療機...リモートジョブ
- ...種 薬事、メディカルライティング 業務内容 Lead regulatory strategy and compliance for innovat... ...verseeing all aspects of regulatory affairs for assigned products, ensuring tim... ...ies.■Main tasks include・Prepare and manage regulatory submissions to Japanese ...
- Job Description POSITION OVERVIEW: The Associate Director of the Regulatory Affairs (RA) is responsible for the overall management of regulatory affairs activities including pharmacovigilance work at RA department at PDRA divisi...
- 募集要項 Job Title: Regulatory Affairs Specialist Location: Singapore About Us: A leading pharmaceutical company committed to innovative healthcare solutions across Asia. Dedicated to enhancing patient well-being through rigoro...