Regulatory Start-Up Lead, Operations & Strategy

Advanced Recruiting Partners; Raleigh (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

Advanced Recruiting Partners is seeking a Manager – Regulatory Operations to lead the Regulatory Start-Up team in the United States. You will supervise staff, drive RA and EC submissions, ensure compliance with ICH-GCP, local regulations, SOPs, and client agreements, and mentor team members toward timely, high-quality deliverables.

In this role you will manage project tracking, liaise with vendors, support site identification and feasibility assessments, and contribute to process improvements.

Qualifications

• Experience leading regulatory start-up teams and delivering RA/EC submissions.
• Strong knowledge of ICH-GCP guidelines and local regulatory requirements.
• Proven ability to implement processes, manage workloads, and coach staff.

Responsibilities

• Lead, mentor, and manage Regulatory Start-Up team members.
• Oversee RA/EC submissions, site identification, and regulatory intelligence.
• Develop and maintain project tracking tools for milestones and KPIs.
• Collaborate with HR and department leadership on recruitment and workforce planning.
• Represent Regulatory Start-Up in client meetings and start-up strategy discussions.
• Drive process improvements and SOP development within Regulatory Start-Up.

Skills

Leadership

Regulatory Start-Up

Team Management

Project Management

Regulatory Intelligence

Tools

RA databases

PMS tools

Job description

Advanced Recruiting Partners is seeking a Manager – Regulatory Operations to lead the Regulatory Start-Up team in the United States. You will supervise staff, drive RA and EC submissions, ensure compliance with ICH-GCP, local regulations, SOPs, and client agreements, and mentor team members toward timely, high-quality deliverables.

In this role you will manage project tracking, liaise with vendors, support site identification and feasibility assessments, and contribute to process improvements.