Clinical Regulatory Coordinator — Hybrid (4 Onsite / 1 Remote)

Actalent; Camden (NJ); Hybrid; USD 70,000 - 100,000; Full time

Job summary

Actalent is seeking a Regulatory Coordinator to support a growing Clinical Research team in Camden, NJ. The role focuses on regulatory compliance, study startup, maintenance, and closeout across multiple trials, including FDA-inspection–subject studies.

Ideal candidates have a BS and 2+ years of regulatory experience in clinical research, with strong organizational skills and proficiency in the MS Office suite. This is a hybrid onsite role with Camden-based responsibilities.

Qualifications

• Bachelor's Degree required.
• 2+ years clinical research regulatory experience.
• Experience preparing and managing IRB submissions.
• Knowledge of FDA regulations, GCP, ICH, and HIPAA.
• Experience maintaining regulatory documents and essential study files.
• Strong organizational skills with attention to detail.
• Advanced proficiency with Microsoft Office Suite.

Responsibilities

• Prepare, submit, and track IRB applications, amendments, continuing reviews, and reportable events for timely approvals.
• Maintain complete regulatory binders (electronic and physical) for assigned studies.
• Develop and communicate timelines for regulatory submissions and approvals.
• Provide regular status updates to investigators, sponsors, and leadership.
• Assist in sponsor, regulatory, and FDA inspections and audit readiness.

Skills

Regulatory experience

IRB submissions

Documentation management

Regulatory compliance

Microsoft Office

Education

Bachelor's Degree

Master's Degree

Tools

Microsoft Office

Job description

Actalent is seeking a Regulatory Coordinator to support a growing Clinical Research team in Camden, NJ. The role focuses on regulatory compliance, study startup, maintenance, and closeout across multiple trials, including FDA-inspection–subject studies.

Ideal candidates have a BS and 2+ years of regulatory experience in clinical research, with strong organizational skills and proficiency in the MS Office suite. This is a hybrid onsite role with Camden-based responsibilities.