Director, Regulatory Affairs

The Director, Regulatory Affairs, will be a key sales and delivery leader for the Regulatory Affairs and Drug Development Solutions (RADDS) business. This is a partially billable role whose key responsibilities are driving business growth through expertise-driven, hands-on development of customer proposals, bid defense leadership and customer engagement and relationship development; leading regulatory affairs partnerships; people management, development and mentoring; contributing to the strength and excellence of the RADDS business.,

• Take leadership role in growing the business; lead and develop proposal and bid defense strategy and craft compelling content and messaging
• Act as a Partnership Director for a large and complex stand-alone project or outsourcing program, involving several regulatory or technical deliverables and/or regions, and/or operations
• Mentor and develop staff in various competencies including technical, customer interfacing, selling, program management
• Provide strategic regulatory and/or technical consultancy on a variety of projects
• Competently lead meetings/manage expectations with Regulatory Agencies and/or groups within IQVIA
• May lead/chair a session on Regulatory Affairs or related topics at a conference; deliver effective presentations to a broad audience
• Contribute to RADDS customer, sales, operational, organizational strategy; lead and implement regional and global objectives
• May 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 addressing employee development needs; 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
• Ensure staff have a consistent understanding and positive impression of strategy for regional and global objectives; lead strategic initiatives and develops implementation plans
• Undertake risk analysis and manage the outcome as appropriate
  
  Bachelor's Degree in life sciences or related discipline required
• Master's Degree in life sciences or related discipline preferred
• At least 8 years regulatory experience including 6 years regulatory project/program leadership experience
• Direct customer relationship management experience with demonstrated awareness of senior regulatory leaders' key concerns and priorities and how a regulatory service provider can address and support those priorities
• Line management experience preferred, 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
• 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 high-pressure situations
• Financial and business acumen
• Strong software and computer skills, including MS Office applications
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies
  
  IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes. To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.