Regulatory Specialist

Job Title:

Regulatory Specialist

We are seeking a dedicated Regulatory Specialist to manage and maintain accurate, complete, and inspection-ready regulatory files for assigned clinical trials. This role involves preparing and submitting regulatory documents, managing study submissions, and ensuring compliance with applicable regulations.

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.

Essential Skills

+ IRB submissions

+ Regulatory compliance

+ GCP guidelines

+ Regulatory submission

+ Clinical research

Additional

Skills & 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 time-management skills with the ability to manage multiple studies, priorities, and deadlines simultaneously.

+ Strong written and verbal communication skills.

+ Ability to work independently with minimal supervision while collaborating effectively with investigators and cross-functional teams.

+ Proficiency with Microsoft Office, including Word, Excel, and Outlook.

+ High school diploma or equivalent required; bachelor's degree in a healthcare, life sciences, or related field preferred.

Work Environment

This position requires working from an office located in Coconut Grove, South Florida. Candidates must reside in the area and be able to reliably commute to the office daily.

Job Type & Location

This is a Contract to Hire position based out of Miami, FL.

Pay and Benefits

The pay range for this position is $32.00 - $38.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract to Hire position based out of Miami, FL.

Final date to receive applications

This position is anticipated to close on Oct 16, 2026.

Workplace Type

This is a fully onsite position in Miami,FL.

About Actalent

Actalent is a global leader in engineering and sciences services and talent…