Director, Reg Affairs

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.

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;

CROでのRA経験必須（ビジネスを理解している）

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

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

GCPなど各種社内外研修

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