Regulatory Coordinator Jobs
Regulatory Coordinator jobs are open across pharmaceuticals, medical devices, food and beverage, and financial services, from entry-level to senior and manager, with specializations in submissions management, compliance documentation, and regulatory affairs. See the openings below and apply to the ones that match your experience.
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Fortrea's FSP team is hiring a Clinical Trial Coordinator- Regulatory - Remote US
Job Overview:
We are seeking a Clinical Trial Coordinator – Regulatory to serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
Responsibilities:
- Serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
- Monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
- Assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits).
- Perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Fortrea or client data management systems, as assigned by management.
- Assist with the coordination of study visits and shipment of drug, ancillary supplies and laboratory kits/samples.
- Manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
- Liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
- Proactively work with sites and project teams to ensure maintenance activities (including Amendments, revised documents, etc.) are completed for assigned sites as applicable in region.
- Demonstrate an understanding of the purpose of CTMS, how to use it, and how to navigate within the different sections. To enter weekly details in CTMS or as per study requirement.
- Assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable in region.
- Facilitate translation and back translation of all necessary documents as appropriate for local country requirements and as needed regionally.
- Attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.
Requirements:
- At least one year of experience in a related field, (e.g. medical, clinical, pharmaceutical, laboratory research, data analysis, data management or technical writing).
- 1-2 years of clinical research is required.
- Basic understanding of biology and biological processes
- Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP.
- Good organizational and time management skills
- Good communication skills, oral and written
- Exhibits general computer literacy
- Works efficiently and effectively in a matrix environment
Qualifications (Minimum Required):
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology).
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Physical Requiremen ts:
- Ability to sit for extended periods and operate a vehicle safely.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Regular and consistent attendance.
- Varied hours may be required.
- Target Pay Range: $65-75K
Learn more about our EEO & Accommodations request here .
Fortrea's FSP team is hiring a Clinical Trial Coordinator- Regulatory - Remote US
Job Overview:
We are seeking a Clinical Trial Coordinator – Regulatory to serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
Responsibilities:
- Serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites.
- Monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.
- Assist CRAs with preparation for site visits (i.e. running reports, QC of files (checking for missing documents), resolving action items from previous visits).
- Perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Fortrea or client data management systems, as assigned by management.
- Assist with the coordination of study visits and shipment of drug, ancillary supplies and laboratory kits/samples.
- Manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.
- Liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.
- Proactively work with sites and project teams to ensure maintenance activities (including Amendments, revised documents, etc.) are completed for assigned sites as applicable in region.
- Demonstrate an understanding of the purpose of CTMS, how to use it, and how to navigate within the different sections. To enter weekly details in CTMS or as per study requirement.
- Assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable in region.
- Facilitate translation and back translation of all necessary documents as appropriate for local country requirements and as needed regionally.
- Attend, as needed, meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.
Requirements:
- At least one year of experience in a related field, (e.g. medical, clinical, pharmaceutical, laboratory research, data analysis, data management or technical writing).
- 1-2 years of clinical research is required.
- Basic understanding of biology and biological processes
- Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP.
- Good organizational and time management skills
- Good communication skills, oral and written
- Exhibits general computer literacy
- Works efficiently and effectively in a matrix environment
Qualifications (Minimum Required):
- University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology).
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Physical Requiremen ts:
- Ability to sit for extended periods and operate a vehicle safely.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Regular and consistent attendance.
- Varied hours may be required.
- Target Pay Range: $65-75K
Learn more about our EEO & Accommodations request here .
Regulatory Coordinator Jobs by Experience Level
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Find Regulatory Coordinator JobsRegulatory Coordinator Job Market
Who's Hiring
Top Industries Hiring
- Healthcare & Medical Services
- Science & Research
- Technology & Software
What Employers Look For
The qualifications that appear most often in regulatory coordinator jobs.
- Bachelor's degree in life sciences, chemistry, biology, or a related field
- Experience maintaining regulatory submissions or document management systems
- Familiarity with FDA regulations, 21 CFR, or relevant agency guidelines
- Proficiency with regulatory information management systems such as Veeva Vault or MasterControl
- Strong attention to detail and ability to manage multiple submission deadlines
- RAC certification from the Regulatory Affairs Professionals Society preferred for senior roles
Tips for Your Regulatory Coordinator Job Search
Tailor your resume to submission types
Regulatory coordinators are hired for specific submission types like 510(k), NDA, BLA, or FSMA filings. Naming the exact submission frameworks you've supported signals fit far faster than listing generic regulatory experience.
List your regulatory databases by name
Hiring managers scan for familiarity with Veeva Vault, MasterControl, RIMS, or eCTD authoring tools. If you've used them, name each one explicitly in your skills section rather than grouping them under a vague systems category.
Apply early to roles that fit
Migrate Mate lists regulatory coordinator openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Filter openings by regulatory agency focus
FDA, EMA, DEA, and EPA each require different expertise. When searching, narrow to openings that name the specific agency whose requirements you know best, so your application speaks directly to what that team needs.
Prepare a submission timeline example for interviews
Interviewers for regulatory coordinator roles frequently ask how you've managed competing submission deadlines. Walk in with a concrete example naming the submission type, the timeline, and how you tracked dependencies across departments.
Negotiate start dates around pending certifications
If you're completing a RAC credential or finishing a relevant course, ask for a start date that lets you arrive fully certified. Hiring managers in regulatory affairs expect this conversation and often accommodate it without issue.
Regulatory Coordinator Jobs: Frequently Asked Questions
Which companies are hiring the most regulatory coordinators?
The companies hiring the most regulatory coordinators right now include University of Colorado, Katalyst Healthcares & Life Sciences, and Miami Dade County, with the largest share of openings in California, Massachusetts, and Colorado, based on current listings on Migrate Mate as of November 2026. Pharmaceutical manufacturers, medical device companies, and contract research organizations consistently account for the highest volume of postings.
How many regulatory coordinator jobs are remote?
About 64% of regulatory coordinator openings are fully remote or hybrid as of November 2026, with availability depending heavily on the employer's document control infrastructure. Submissions coordination and regulatory writing roles tend to offer the most remote flexibility, while positions tied to on-site lab audits or manufacturing floor compliance generally require in-person presence.
How do you become a regulatory coordinator?
Start with a bachelor's degree in a life science, chemistry, or health-related field, then build hands-on exposure through internships, co-ops, or entry-level roles in quality assurance or document control. Getting familiar with FDA regulations and a document management system strengthens early applications significantly. Many coordinators also pursue RAC certification once they have a few years of experience to deepen their credibility.
Can you get a regulatory coordinator job with little experience?
Yes, entry-level regulatory coordinator roles exist specifically for candidates coming from adjacent backgrounds like quality assurance, clinical research coordination, or laboratory work. Employers in medical devices and food and beverage industries are particularly open to candidates who demonstrate strong document management habits and a working knowledge of the relevant regulatory framework, even without direct submissions experience.
What does the regulatory coordinator interview process look like?
Most regulatory coordinator interviews involve an initial screening with HR, followed by a technical round with the regulatory affairs manager or a senior coordinator. Expect questions about how you've tracked submission timelines, managed document version control, and handled requests from cross-functional teams. Some employers add a brief writing or document review exercise to assess attention to detail before extending an offer.
Where can I find and apply to regulatory coordinator jobs?
You can find and apply to regulatory coordinator jobs on Migrate Mate, which lists current openings from across the United States. Search for roles that match your regulatory background, industry focus, and preferred location, then apply directly to each listing that fits.
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