Dir, Reg Affairs (Regulatory Affairs)

Location: Durham, North Carolina, United States of America

Annual base pay: $128,800–$358,800

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Lead Regulatory Affairs staff and manage one or more sites, including workload allocation, performance management, professional development, and employee relations.
• Manage team resources, quality metrics, reporting, operational challenges, and project delivery.
• Implement regional and global strategic objectives and lead strategic initiatives and implementation plans.
• Maintain full financial responsibility for assigned Regulatory Affairs sites and monitor growth and performance.
• Manage risk, complex regulatory projects, technical deliverables, and strategic regulatory consultancy engagements.
• Engage with regulatory agencies, support bid defense strategy, and deliver conference presentations or lead Regulatory Affairs sessions.

Requirements

• Bachelor’s or master’s degree in life science or a related discipline.
• At least 8 years of regulatory experience, including 6 years of management experience.
• Line management experience with demonstrated success developing, engaging, and managing senior staff.
• Advanced negotiation, influencing, issue-resolution, communication, and leadership skills.
• Ability to work effectively with senior management during organizational change and high-pressure situations.
• Strong financial awareness, software skills including Microsoft Office, and applicable professional certifications or licenses.

Culture & Benefits

• Full-time employment with potential incentive plans, bonuses, and health and welfare benefits.
• Equal opportunity employment practices.
• Work is connected to regional and global healthcare and life sciences initiatives.