Director, Regulatory Affairs
IQVIA
Summary
Line Management responsibilities for a Regulatory Affairs site or combination of sites.
Job description
Job Overview
Line Management responsibilities for a Regulatory Affairs site or combination of sites.
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 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
Requirements
- Bachelor's Degree in Life Sciences or related discipline, or Master's Degree in Life Sciences 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 ability to identify and resolve issues using flexible adaptable approach
- Remains calm, assertive and diplomatic in challenging interactions with customers and staff
- Acute awareness of issues outside the business function; exudes confidence and authority within remit
- Communicates an inspiring vision of the Regulatory Strategic Plan
- Ability to work effectively with senior management, remaining motivated and enthusiastic in times of change and pressure
- 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
Benefits
- Health and welfare benefits
- Incentive plans
- Bonuses
Company overview
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. Headquartered in Durham, North Carolina, the company operates in over 100 countries with approximately 86,000 employees worldwide. IQVIA specializes in creating intelligent connections across all aspects of healthcare through its proprietary IQVIA Connected Intelligence platform, which combines analytics, transformative technology, big data resources, and extensive domain expertise. The company's comprehensive portfolio includes clinical trial management, real-world evidence generation, commercial insights, and regulatory compliance services. IQVIA serves a diverse client base including pharmaceutical manufacturers, biotechnology companies, medical device firms, government agencies, and healthcare providers. With its Healthcare-grade AI capabilities and extensive global data assets, IQVIA accelerates the development and commercialization of innovative medical treatments while improving healthcare outcomes for patients globally. The company is publicly traded on the New York Stock Exchange under the ticker symbol IQV.