Director, Regulatory Affairs job opportunity at IQVIA Holdings, Inc..

Home Jobs In Japan Tag: Regulatory Affairs Director, Regulatory Affairs position at IQVIA Holdings, Inc.


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IQVIA Holdings, Inc. Director, Regulatory Affairs
Experience: 8-years
Pattern: full-time
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Regulatory Affairs

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degreeDiploma
loacation Tokyo, Japan, Japan
loacation Tokyo, Japan....Japan

【会社紹介 ・ビジョン 】   私たち IQVIA は、ヒューマンデータサイエンスの先駆的な企業として、医療・ヘルスケアの前進に取り組む皆様を IQVIA ならではの革新的なソリューションによってご支援することで、「誰もが、より健康に自分らしく生きられる社会」の実現を目指しています。世界最大規模を誇る医療・ヘルスケア関連データを基盤に、人・データ・サイエンスを融合させた見地から、未だ満たされない治療ニーズに応える、新たな医薬品や医療機器の開発と市販化、厳格化する規制やコンプライアンスへの対応、持続可能な医療システム推進の支援など、患者さんをはじめとするすべての人々のために、より良い未来へと医療・ヘルスケアを前進させていく力となることが、私たちの使命です。   世界 100 以上の国と地域で約 9 万人が活動する IQVIA の日本法人として、 IQVIA ジャパンでは約 6,000 人が一丸となり、この使命に向かって日々、力を尽くしています。 【 部署・チーム名 】   グローバルで先行していた「RADDS」（Regulatory Affairs & Drug Development Solutions）と呼ばれる新組織を日本でも始動。顧客のニーズに応じて薬事対応、開発戦略立案、臨床開発などのサービスを一体的に提供する体制を構築しました。グローバルとも連携して海外の新興バイオファーマ（EBP）を日本に呼び込むとともに、日本のバイオベンチャーの海外開発・申請をサポートします。 RADDS Japan was established to support EBP initiative for business growth in RD&S. This position requires the successful candidate to support the activities in RADDS Japan which includes contributing to the scoping, integrated proposal compilation, and delivery oversight of multi-disciplinary biopharmaceutical development advisory/clinical trial enablement projects. 【業務内容】 ・Manage staff in accordance with organization’s policies and applicable regulations; Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; Approve actions on human resources matters, including salary administration. ・Effectively manages the team's resources and delegates tasks commensurate with skill level; Evaluates workload, quality and metrics through regular review and reporting of findings; Effectively collaborate with operational colleagues to manage project- and team-related challenges; Contributes to discussions on implementation of business strategy on a regional basis and will implement regional and global specific objectives, as appropriate. ・Ensures staff have a consistent understanding and positive impression of strategy for regional and global objectives; Leads strategic initiatives and develops implementation plans; ・Will have full financial responsibility and accountability for one or more Regulatory Affairs sites; monitors growth and performance of the sites; Undertakes risk analysis and manages the outcome as appropriate; ・May act as a Project Manager for a large and complex stand-alone project or programme, involving several regulatory or technical deliverables and/or region, and/or operations; ・May provide strategic regulatory and/or technical consultancy on a variety of projects; •Competently manages meetings/expectations with Regulatory Agencies and/or groups within IQVIA; •May take leadership role in bid defense strategy and planning; •May lead/chair a session on Regulatory Affairs or related topics at a conference; deliver effective presentations to a broad audience; メーカーやCROでの薬事経験者 ラインマネジメントの経験 ・At least 8 years regulatory experience including 6 years management experience. ・Requires broad management knowledge to lead teams, and well as the ability to influences others outside of own job area regarding policies, procedures, and goals. ・Possess demonstrated working knowledge of corresponding professional grade level responsibilities, skills and abilities, as required for guidance of staff Line management experience required, with demonstrated success in development, engagement and performance of senior staff. ・Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach.  Remains calm, assertive and diplomatic in challenging interactions with customers and staff ・Possesses an acute awareness of issues outwith the business function.  Exudes confidence and authority within remit, and delivers a positive example to teams ・Communicates an inspiring vision of the Regulatory Strategic Plan and helps others understand and value their role in it. ・Ability to work effectively with senior management, remaining motivated and enthusiastic in times of change and other pressure situations 【部署・ポジションの醍醐味、楽しさ、やりがい】 ・有用な医薬品の早期の開発、承認に貢献できる ・再生医療を含む、最先端の医療へ関与できる ・Projectをリードし、クライアントとのコミュニケーションを含め、自己完結で業務遂行できる ・様々な領域（治療領域、生物的製剤、再生医療等）での経験が積める 【特別な研修・サポート制度等】 ・英語研修 ・GCPなど各種社内外研修 ・医薬品開発に関する部内外研修 ・学会への参加 【雇用形態・ 勤務時間・ 福利厚生・ 休日休暇 】   雇用形態：正社員／契約社員など   勤務時間： 9:00-17:30    フレックス勤務： あり   在宅勤務制度：あり   福利厚生： 法定内 （社会保険制度） ・法定外 （ IQVIA 独自制度） の両面から充実した福利厚生制度 あり   受動喫煙対策：あり   休日休暇： 年次有給休暇、夏季休暇、病気休暇、特別休暇、女性特別休暇、育児介護休暇、看護休暇· など   試用期間：あり（通常６か月）   【 給与・待遇 】   給与： 当社規定により優遇します   昇給： あり   賞与 ： あり   時間外手当： あり   【 選考プロセス 】   書類選考→部門とのカジュアル面談→応募後、部門面接（3回あり） 【応募方法】   日本語の履歴書、職務経歴書、英語職務経歴書の3点をご準備ください。 IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

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