Senior Regulatory Affairs Director & Team Leader

Regulatory Toolkit; Durham (NC); On-site; USD 104,000 - 289,000; Full time

Job summary

IQVIA is seeking an experienced Regulatory Affairs leader to manage a team of regulatory staff and oversee one or more sites. You will drive regulatory strategy and ensure delivery of quality regulatory projects in line with global business plans.

You will coordinate cross-functional efforts, mentor staff, and liaise with regulatory agencies while contributing to business development and process improvements. A strong track record in leadership and regulatory expertise is essential.

Qualifications

• Bachelor's degree in life sciences or related field.
• Master's degree in life sciences or related field preferred.
• At least 6 years regulatory experience including 3 years of management.
• Possesses specific regulatory or technical expertise.
• Strong interpersonal communication (oral and written) and organizational skills.
• Proficient in Microsoft Office applications.
• Demonstrates negotiation skills and the ability to make decisions with minimal supervision.
• Ability to manage multiple projects with quality and timelines.

Responsibilities

• Line management of Regulatory staff, including performance and development.
• Coordinate projects and resources to ensure quality deliverables to customers.
• Contribute to regional/global strategy and set site-specific objectives.
• Possibly oversee budget, business development, and growth monitoring.
• Manage meetings with Regulatory Agencies as needed.
• Lead regulatory program management and provide technical consultancy.
• Prepare and defend complete regulatory proposals with costs and timelines.
• Deliver regulatory workshops or presentations for conferences or publications.
• Drive process improvements within regulatory operations.

Skills

Staff management

Regulatory affairs

Project management

Negotiation

Communication

Team leadership

Education

Bachelor's degree in life sciences

Master's degree in life sciences

Tools

Microsoft Office

Job description

IQVIA is seeking an experienced Regulatory Affairs leader to manage a team of regulatory staff and oversee one or more sites. You will drive regulatory strategy and ensure delivery of quality regulatory projects in line with global business plans.

You will coordinate cross-functional efforts, mentor staff, and liaise with regulatory agencies while contributing to business development and process improvements. A strong track record in leadership and regulatory expertise is essential.