Director, Regulatory Affairs | Strategy & Site Lead

IQVIA; Durham (NC); On-site; USD 129,000 - 359,000; Full time

Job summary

IQVIA in Durham, NC is seeking an experienced Line Manager for Regulatory Affairs to lead a site or several sites, overseeing staff, budgeting, and compliance with regulatory standards.

The role requires strong leadership, regulatory expertise, and the ability to align regional and global objectives with site operations. You will mentor staff, drive performance, and manage complex regulatory projects as needed.

Qualifications

• Bachelor's degree in Life science or related discipline.
• Master's degree in Life science or related discipline.
• 8+ years regulatory experience including 6 years management.
• Line management experience with development and performance of senior staff.
• Advanced negotiating and influencing skills; calm under pressure.
• Ability to lead and communicate regulatory strategic plans to senior management.
• Strong MS Office skills.
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies.

Responsibilities

• Lead staff in accordance with policies and regulations; plan, assign, direct, appraise performance, and manage HR actions.
• Monitor workload, quality, and metrics; review and report findings.
• Collaborate with operations to address project and team challenges.
• Implement regional/global objectives and strategic plans; manage regional/regulatory initiatives.
• Ensure understanding of strategy and lead implementation efforts.
• Take financial responsibility for one or more sites; monitor growth and performance.
• Conduct risk analysis and manage outcomes.
• Act as Project Manager for large/complex regulatory projects or programs.
• Provide strategic regulatory/technical consultancy as needed.
• Lead/participate in meetings with regulatory agencies and IQVIA groups.

Skills

Line management

Budgeting / financial accountability

Regulatory affairs knowledge

Staff development

Negotiation skills

MS Office

Education

Bachelor's Degree in Life sciences

Master's Degree in Life sciences

Job description

IQVIA in Durham, NC is seeking an experienced Line Manager for Regulatory Affairs to lead a site or several sites, overseeing staff, budgeting, and compliance with regulatory standards.

The role requires strong leadership, regulatory expertise, and the ability to align regional and global objectives with site operations. You will mentor staff, drive performance, and manage complex regulatory projects as needed.