Regulatory Specialist

Actalent; Miami (FL); Presencial; USD 44 000 - 52 000; Tempo integral

Resumo da oferta

Actalent is seeking a Regulatory Specialist to manage and maintain inspection-ready regulatory files for assigned clinical trials. You will prepare and submit regulatory documents, track deadlines, and ensure adherence to FDA, ICH-GCP, and IRB requirements.

The role requires at least 2 years of regulatory experience in clinical research, strong attention to detail, and proficiency with MS Office. This is a fully onsite, contract-to-hire position based in Miami, FL.

Qualificações

• At least 2 years of clinical research regulatory experience.
• Hands‑on experience preparing and managing IRB submissions and regulatory documents.
• Working knowledge of FDA regulations, ICH-GCP guidelines, and clinical research requirements.
• Strong understanding of essential study documents and regulatory file maintenance.
• Excellent attention to detail and organizational skills.
• Strong time-management skills with the ability to manage multiple studies, priorities, and deadlines.
• Strong written and verbal communication skills.
• Ability to work independently with minimal supervision while collaborating with cross‑functional teams.
• Proficiency with Microsoft Office, including Word, Excel, and Outlook.
• Bachelor's degree in healthcare, life sciences, or related field preferred.

Responsabilidades

• Prepare and submit regulatory documents to IRBs, sponsors, and CROs.
• Manage initial study submissions, continuing reviews, amendments, informed consent revisions, and study closures.
• Prepare or adapt informed consent forms, ensuring all required elements are appropriately incorporated.
• Track IRB submissions, approvals, expirations, and 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.

Conhecimentos

IRB submissions

Regulatory compliance

GCP guidelines

Regulatory submission

Clinical research

Formação académica

High school diploma or equivalent

Bachelor's degree in healthcare or life sciences (preferred)

Ferramentas

Microsoft Office

Descrição da oferta de emprego

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.

Application Deadline

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 solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News‑Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.