Associate Director, Regulatory Affairs

IQVIA•Durham, NC

1d•$103,600 - $288,600

About The Position

The Associate Director, Regulatory Affairs provides line management for a team of Regulatory staff or may be responsible for the performance of one or more Regulatory Affairs sites. The role develops regulatory business in accordance with Global Regulatory Affairs business plans and participates in project-related work as needed. It may include financial accountability, business development, risk management, project leadership, regulatory consultancy, client proposal work, and engagement with Regulatory Agencies. The role also leads improvements to processes, systems, or products and may contribute to regional and global regulatory initiatives.

Requirements

Bachelor's degree in a life science or related discipline, or a master's degree in a life science or related discipline.
At least 6 years of regulatory experience, including 3 years of management experience, or an equivalent combination of education, training, and experience.
Specific regulatory or technical expertise.
Strong oral and written interpersonal communication and organizational skills.
Strong software and computer skills, including Microsoft Office applications.
Demonstrated negotiation skills and confidence making decisions with minimal supervision.
Ability to manage several projects while maintaining quality and timelines.
Working knowledge of the responsibilities, skills, and abilities associated with the relevant professional grade level to guide staff.
Demonstrated success leading teams or prior supervisory experience.
Advanced negotiating and influencing skills, including the ability to identify and resolve issues using a flexible and adaptable approach.
Ability to remain calm, assertive, and diplomatic in challenging interactions with staff and customers.
Professional conduct and a positive attitude in interactions with colleagues and customers.
Ability to understand and promote Corporate and Global Regulatory Affairs business strategies to staff.
Ability to provide fair, timely, appropriate, and constructive feedback and guidance.
Ability to earn staff trust and handle personnel issues, expectations, and conflict management with confidentiality and sensitivity.
Confidence and appropriate communication when representing staff issues or concerns to senior management.
Line management experience with demonstrated success in staff development, engagement, and performance.
Ability to manage competing priorities.
Effective communication across organizational levels and ability to remain motivated and enthusiastic during change and pressure situations.
Practical knowledge of leading and managing processes, projects, and tactics within one or multiple related departments.
Ability to exercise independent judgment and take calculated risks when making decisions.
Applicable certifications and licenses as required by country, state, or other regulatory bodies.

Responsibilities

Manage Regulatory staff in accordance with organizational policies and applicable regulations, including assigning and directing work, evaluating performance, guiding professional development, handling employee relations, and approving human resources actions such as salary administration.
Independently address personnel issues and conflicts, set staff goals and expectations, and support staff knowledge and skills development.
Coordinate projects and resources to ensure high-quality customer deliverables.
Contribute to regional business strategy discussions and set and implement site-specific objectives as appropriate.
Promote staff understanding of regional and global business strategy.
Undertake financial accountability for one or more Regulatory Affairs sites when applicable, and conduct business development activities and monitor growth and performance as required.
Conduct risk analysis and manage outcomes as appropriate.
Build relationships with managers in other operations and represent Regulatory Affairs positively.
Act as project manager for large stand-alone programs involving multiple regulatory or technical deliverables, regions, or operations, and provide strategic regulatory or technical consultancy as needed.
Manage meetings with Regulatory Agencies when applicable.
Write or review single-service regulatory proposals and defend costs and timelines to clients when applicable.
Plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications when applicable.
Lead moderate to significant improvements to processes, systems, or products to enhance performance.
Review or approve Regulatory or cross-functional standard operating procedures when assigned.
Support global regulatory or technical initiatives or represent the region on cross-functional initiatives.
Perform other duties as business needs require.