Regulatory Start-Up Leader: Trials & Site Strategy

Advanced Recruiting Partners

Raleigh (NC)

On-site

USD 120,000 - 180,000

Full time

2 days ago

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Job summary

Advanced Recruiting Partners seeks a Manager – Regulatory Operations to lead the Regulatory Start-Up team, ensuring timely submissions and high-quality deliverables. You will supervise staff, manage onboarding, and align with SOPs, RA/EC requirements, and regulatory intelligence.

The role requires 7+ years in pharma/CRO, strong start-up expertise, and proven project management with line management experience. Collaboration with cross-functional teams and external vendors is essential.

Qualifications

Bachelor's degree in a clinical or life sciences field or equivalent industry experience.
Minimum 7 years in pharma/biotech/CRO with demonstrated leadership responsibilities.
Strong background in clinical trial regulatory start-up and submissions.

Responsibilities

Lead, mentor, and manage the Regulatory Start-Up team and onboarding.
Oversee RA and EC submissions, documents, and regulatory timelines.
Develop SOPs, drive process improvements, and ensure regulatory compliance.
Partner with HR on recruitment, performance reviews, and staff development.
Coordinate with internal and external stakeholders to maintain project schedules.