Job Description

HIGHLIGHTS

• Lead a team of 3–5 in regulatory, quality, and compliance oversight
• Onsite leadership role at a Phase I-focused research site
• Opportunity to shape regulatory operations in a high-growth environment
• Sign-on bonus available for relocation, based on candidate location
• $150k-$165k + Bonus
• Full benefits package including health insurance, PTO, holidays, and 401(k) match

COMPANY

Our client is a fast-growing clinical research site conducting Phase I–IV trials with an emphasis on early-phase work. They offer a dynamic, entrepreneurial environment and are part of a broader site network that spans 10 states and over 30 locations. This is a rare opportunity to lead regulatory strategy at a site positioned for significant growth in 2025 and beyond.

POSITION

The Regulatory Director will oversee regulatory operations while managing a team that includes study startup, quality, and compliance professionals. This is an onsite role in Gainesville, GA, requiring full-time presence Monday through Friday. The position offers a competitive salary, a bonus structure, and relocation support in the form of a sign-on bonus.

RESPONSIBILITIES

• Direct and oversee all regulatory submissions and processes for ongoing and upcoming trials
• Manage and mentor a team including study startup, QA/compliance, and quality staff
• Ensure adherence to ICH-GCP, FDA, and institutional guidelines
• Collaborate cross-functionally to support inspection readiness and audit response
• Implement process improvements for regulatory workflows and document control

QUALIFICATIONS

• 5+ years of regulatory experience in a clinical research environment
• Strong understanding of FDA, GCP, and ICH guidelines
• Leadership experience overseeing quality, compliance, or study startup teams
• Experience with early phase (Phase I) trials is preferred but not required
• Must be willing to relocate to Gainesville, GA for an onsite role

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