Clinical Trials Regulatory Specialist

Actalent; Miami (FL); On-site; USD 44,000 - 52,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

PTO

Transportation benefits

Job summary

Actalent is seeking a Regulatory Specialist to manage regulatory files for assigned clinical trials, prepare submissions to IRBs, sponsors, and CROs, and ensure compliance with FDA/ICH-GCP guidelines.

The role requires at least 2 years of regulatory experience, strong attention to detail, and the ability to work independently with cross-functional teams. This is a fully onsite contract-to-hire position in Miami, FL with hourly compensation.

Qualifications

• At least 2 years of clinical research regulatory experience.
• Hands-on experience preparing and managing IRB submissions and clinical trial regulatory documents.
• Working knowledge of FDA regulations, ICH-GCP guidelines, and clinical research requirements.
• Strong understanding of essential study documents and regulatory file maintenance.
• Exceptional attention to detail and organizational skills.
• Strong written and verbal communication skills.
• Ability to work independently with minimal supervision while collaborating with investigators and cross-functional teams.

Responsibilities

• Prepare and submit regulatory documents to IRBs, sponsors, and CROs as required.
• Manage initial study submissions, continuing reviews, protocol amendments, informed consent revisions, and study closures.
• Prepare and/or adapt informed consent forms, ensuring all required elements are appropriately incorporated.
• Track IRB submissions, approvals, expirations, and other regulatory deadlines.
• Maintain and submit Investigator Brochures and subsequent revisions throughout the study lifecycle.
• Coordinate regulatory documentation related to protocol amendments, safety information, and serious adverse events.
• Track and distribute sponsor safety letters and other regulatory correspondence as required.
• Prepare and submit interim reports, continuing reviews, and final study reports.
• Maintain current investigator and study staff documentation, including CVs, licenses, certifications, training records, and other essential documents.
• Communicate effectively with investigators, sponsors, CROs, monitors, IRBs, and internal study teams regarding regulatory requirements and outstanding items.
• Support study start-up activities by collecting, preparing, reviewing, and submitting required regulatory documentation.
• Support monitoring visits, audits, and inspections by ensuring regulatory documentation is complete and readily available.
• Prepare regulatory study files for closeout and archiving.
• Maintain compliance with applicable FDA regulations, ICH-GCP guidelines, IRB requirements, study protocols, and VIN SOPs.

Skills

IRB submissions

Regulatory compliance

GCP guidelines

Regulatory submission

Clinical research

Education

Bachelor's degree preferred (healthcare, life sciences, or related field)

Job description

Actalent is seeking a Regulatory Specialist to manage regulatory files for assigned clinical trials, prepare submissions to IRBs, sponsors, and CROs, and ensure compliance with FDA/ICH-GCP guidelines.

The role requires at least 2 years of regulatory experience, strong attention to detail, and the ability to work independently with cross-functional teams. This is a fully onsite contract-to-hire position in Miami, FL with hourly compensation.