Regulatory Affairs Coordinator

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

Job summary

Actalent seeks a detail-oriented Regulatory Coordinator to support a growing Clinical Research team in Camden, NJ. You will manage IRB submissions, regulatory binders, and communications with investigators, sponsors, and regulatory bodies.

The role covers study startup, maintenance, and closeout, with vigilance for GCP, ICH, FDA, and HIPAA requirements across multiple trials, including potential FDA inspections.

Qualifications

• Bachelor's Degree required.
• 2+ years of 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.

Responsibilities

• Prepare, submit, and track IRB applications, amendments, continuing reviews, and reportable events.
• Maintain regulatory binders (electronic and physical) for assigned studies.
• Develop and communicate timelines for regulatory submissions and approvals.
• Provide status updates to investigators, sponsors, and leadership.

Skills

Regulatory submissions experience

Attention to detail

Organizational skills

Education

Bachelor's Degree

Tools

Microsoft Office Suite

Job description

Schedule: 4 days onsite and 1 day remote

Overview

We are seeking a detail-oriented Regulatory Coordinator to support a growing Clinical Research team. This individual will play a critical role in ensuring regulatory compliance and maintaining accurate documentation for multiple clinical research studies. The position will support study startup, maintenance, and closeout activities while serving as a key liaison between investigators, sponsors, and institutional regulatory bodies. This is an exciting opportunity to join a high-impact research environment supporting several active clinical trials, including studies that may be subject to FDA inspection.

Key Responsibilities

• Prepare, submit, and track all Institutional Review Board (IRB) applications, amendments, continuing reviews, and reportable events to ensure timely approvals and ongoing compliance.
• Maintain complete and accurate regulatory binders (electronic and physical) for assigned studies.
• Manage essential study documentation including:

• FDA Form 1572s
• Delegation of Authority (DOA) logs
• Financial Disclosure Forms (FDFs)
• Investigator and staff CVs
• Medical licenses
• Training records
• Other required regulatory documents

• Develop and communicate timelines for regulatory submissions and approvals.
• Provide regular status updates to investigators, study coordinators, sponsors, and research leadership.
• Conduct internal quality control reviews of regulatory files across research locations to ensure compliance with:

• Good Clinical Practice (GCP)
• International Council for Harmonisation (ICH) Guidelines
• HIPAA regulations
• FDA requirements

• Support study startup, maintenance, closeout activities, and audit readiness initiatives.
• Assist in preparing for sponsor, regulatory, and FDA inspections.

Required Qualifications

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

Preferred Qualifications

• Master's Degree (MS)
• Experience supporting clinical trials in Neurology
• Experience working in an academic medical center, hospital, or clinical research setting
• Experience preparing studies for regulatory audits or FDA inspections

Job Type & Location

This is a Permanent position based out of Camden, NJ.

Pay And Benefits

The pay range for this position is $70000.00 - $100000.00/yr.

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.

Permanent benefits in attachment

Workplace Type

This is a fully onsite position in Camden,NJ.

Application Deadline

This position is anticipated to close on Sep 29, 2026.

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.