Director, Regulatory Affairs - Home based - US/Europe

IQVIA has the rare opportunity to appoint a leader within the Regulatory Affairs team to be a line manager and strategy leader for our clients. Working with the wider IQVIA ecosystem to deliver innovative and cutting edge solutions to our clients. You will have responsibilities for a Regulatory Affairs site or combination of sites across the EU.

Essential Functions

• 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;

Qualifications

• Bachelor's Degree Degree in Life science or related discipline Req Or
• Master's Degree Degree in Life science or related discipline
• At least 8 years regulatory experience including 6 years management experience
• 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 out with 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

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.