Dir, Reg Affairs

IQVIA•Durham, NC

1d•$128,800 - $358,800

About The Position

The Director, Regulatory Affairs has line management responsibilities for a Regulatory Affairs site or combination of sites. The role leads staff, resources, site performance, and implementation of regional and global business objectives. It carries full financial responsibility and accountability for one or more Regulatory Affairs sites and may include project management, strategic regulatory or technical consulting, regulatory agency engagement, bid defense leadership, and conference presentations.

Requirements

Bachelor's degree in Life Science or a related discipline, or a master's degree in Life Science or a related discipline.
At least 8 years of regulatory experience, including 6 years of management experience.
Demonstrated working knowledge of professional-grade responsibilities, skills, and abilities relevant to guiding staff.
Required line management experience, with demonstrated success in developing, engaging, and managing the performance of senior staff.
Advanced negotiating and influencing skills, including the ability to identify and resolve issues with a flexible and adaptable approach and to remain calm, assertive, and diplomatic in challenging interactions with customers and staff.
Awareness of issues outside the business function; confidence and authority within the role's remit and the ability to set a positive example for teams.
Ability to communicate an inspiring vision of the Regulatory Strategic Plan and help others understand and value their role in it.
Ability to work effectively with senior management and remain motivated and enthusiastic during 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 organizational policies and applicable regulations, including assigning and directing work, evaluating performance, supporting professional development, handling employee relations, resolving problems, and approving human resources actions such as salary administration.
Manage team resources and delegate tasks based on staff skill levels; review workload, quality, and performance metrics and report findings.
Collaborate with operational colleagues to address project- and team-related challenges.
Contribute to regional business strategy discussions and implement appropriate regional and global objectives.
Ensure staff understand and support regional and global strategies; lead strategic initiatives and develop implementation plans.
Hold full financial responsibility and accountability for one or more Regulatory Affairs sites, monitoring site growth and performance.
Undertake risk analysis and manage outcomes as appropriate.
May serve as project manager for large, complex standalone projects or programmes involving multiple regulatory or technical deliverables, regions, or operations.
May provide strategic regulatory and/or technical consultancy on a variety of projects.
Manage meetings and expectations with Regulatory Agencies and/or IQVIA groups.
May lead bid defense strategy and planning.
May lead or chair Regulatory Affairs or related sessions at conferences and deliver presentations to broad audiences.