Director, Regulatory Affairs

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。

【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

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