Regional Regulatory Affairs Director

IQVIA LLC; Durham, Northern (NC, KY); Hybrid; USD 120,000 - 150,000; Full time

Job summary

IQVIA LLC in Durham, NC seeks an experienced Regulatory Affairs leader to manage a team of regulatory staff and drive regional and global regulatory strategies. You will oversee staff development, ensure quality deliverables, and coordinate cross-functional programs across sites.

The role focuses on advancing regulatory submissions, guiding projects, and serving as a liaison with regulatory agencies, while maintaining strong relationships with stakeholders and ensuring alignment with business

Qualifications

• At least 6 years regulatory experience including 3 years in management.
• Ability to lead teams and staff development.
• Strong interpersonal communication and organization skills.
• Advanced negotiating and influencing skills with minimal supervision.
• Experience with regulatory submissions and project management.

Responsibilities

• Manage staff, plan, assign, and direct work; appraise performance.
• Coordinate projects and resources to deliver quality client results.
• Set site-specific objectives and align with regional/global strategy.
• May act as Project Manager for large regulatory programs.
• Provide strategic regulatory and technical consultancy.
• Lead meetings with Regulatory Agencies; defend costs and timelines.
• Write or review regulatory proposals and deliver workshops.

Skills

Regulatory leadership

Staff management

Project management

Negotiation

Communication

Education

Bachelor's Degree Lifescience or related

Master's Degree Lifescience or related

Tools

Microsoft Office

Job description

IQVIA LLC in Durham, NC seeks an experienced Regulatory Affairs leader to manage a team of regulatory staff and drive regional and global regulatory strategies. You will oversee staff development, ensure quality deliverables, and coordinate cross-functional programs across sites.

The role focuses on advancing regulatory submissions, guiding projects, and serving as a liaison with regulatory agencies, while maintaining strong relationships with stakeholders and ensuring alignment with business