Director, Regulatory Affairs & Site Leadership

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

Job summary

Regulatory Toolkit is seeking a seasoned Regulatory Affairs leader to manage a site or multiple locations in the U.S. You will oversee staff performance, strategic planning, and regulatory compliance across regions, influencing global objectives and delivering results.

You will lead a team with full financial accountability for the sites, drive risk management, and collaborate with senior stakeholders to implement regulatory programs and ensure timely project delivery in a dynamic environment.

Qualifications

• Bachelor's Degree in Lifescience or related discipline.
• Master's Degree in Lifescience or related discipline.
• 8+ years regulatory experience including 6+ years in management.
• Line management experience with success in development, engagement and performance of senior staff.
• Advanced negotiating and influencing skills and the ability to identify and resolve issues.
• Acute awareness of issues outwith the business function and ability to lead by example.
• Ability to work with senior management and drive regulatory strategy and change.

Responsibilities

• Lead staff in accordance with policies and regulations, including salary administration.
• Manage resources, delegate tasks, and monitor workload, quality, and metrics.
• Collaborate with operations to manage project- and team-related challenges.
• Implement regional and global objectives and strategic plans.
• Maintain financial accountability for one or more Regulatory Affairs sites.
• Conduct risk analyses and manage outcomes.
• Serve as Project Manager for large, complex projects or programs.
• Provide strategic regulatory/technical consultancy on projects.
• Lead meetings with Regulatory Agencies and bid defense strategy.

Skills

Line management

Regulatory experience

Negotiation

Communication

Financial awareness

Stakeholder management

Problem solving

MS Office

Education

Bachelor's Degree Lifescience

Master's Degree Lifescience

Tools

MS Office

Job description

Regulatory Toolkit is seeking a seasoned Regulatory Affairs leader to manage a site or multiple locations in the U.S. You will oversee staff performance, strategic planning, and regulatory compliance across regions, influencing global objectives and delivering results.

You will lead a team with full financial accountability for the sites, drive risk management, and collaborate with senior stakeholders to implement regulatory programs and ensure timely project delivery in a dynamic environment.