Director Regulatory Affairs
- Experience Level
- Senior Management
IQVIA has an exciting leadership position here within the Global Regulatory Affairs group.
Due to the growth here at IQVIA of new and exciting projects coming through we're looking for a leader in the GRA group to support the ongoing projects from an oversight and project management perspective . This role will also be a core member of client interactions supporting the development of strategies for our clients and supporting internal business development with client integrations.
As a leader in the group, your experience will also be used to support the group with mentoring and line managing the talent within IQVIA through their career and developing their skills.
• 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 program, 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;
• Bachelor'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 ideal, 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 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.