Dir, Reg Affairs

IQVIA•Durham, NC

About The Position

Line Management responsibilities for a Regulatory Affairs site or combination of sites. This role involves managing staff, resources, and financial accountability for one or more Regulatory Affairs sites. The position contributes to the implementation of business strategy on a regional basis and may act as a Project Manager for complex projects or provide strategic consultancy. The company, IQVIA, is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries, aiming to accelerate the development and commercialization of innovative medical treatments.

Requirements

Bachelor's Degree in Lifescience or related discipline OR Master's Degree in Lifescience or related discipline
At least 8 years regulatory experience including 6 years management experience
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
Sound financial awareness
Strong software and computer skills, including MS Office applications
Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

Responsibilities

Manage staff in accordance with organization’s policies and applicable regulations, including 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 manage the team's resources and delegate tasks commensurate with skill level.
Evaluate workload, quality, and metrics through regular review and reporting of findings.
Effectively collaborate with operational colleagues to manage project- and team-related challenges.
Contribute to discussions on implementation of business strategy on a regional basis and implement regional and global specific objectives, as appropriate.
Ensure staff have a consistent understanding and positive impression of strategy for regional and global objectives.
Lead strategic initiatives and develop implementation plans.
Have full financial responsibility and accountability for one or more Regulatory Affairs sites; monitor growth and performance of the sites.
Undertake risk analysis and manage 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 manage 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.