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How much do regulatory submissions coordinator jobs pay per hour?

As of May 28, 2026, the average hourly pay for regulatory submissions coordinator in the United States is $33.23, according to ZipRecruiter salary data. Most workers in this role earn between $24.76 and $38.94 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Regulatory Submissions Coordinator, and why are they important?

To thrive as a Regulatory Submissions Coordinator, you need a solid understanding of regulatory guidelines, submission processes, and document management, typically supported by a life sciences degree or related experience. Familiarity with electronic document management systems (EDMS), regulatory submission software like eCTD, and relevant industry certifications is highly valued. Attention to detail, organizational skills, and effective communication are crucial soft skills for managing complex submissions and collaborating with cross-functional teams. These skills ensure timely, accurate submissions and compliance with regulatory requirements, which are critical for product approvals and company success.

What are some common challenges faced by Regulatory Submissions Coordinators, and how are they typically addressed?

Regulatory Submissions Coordinators often face challenges such as managing tight deadlines, keeping up with frequently changing regulatory requirements, and coordinating input from multiple departments. To address these, professionals in the role rely on strong organizational skills, effective communication with cross-functional teams, and the use of specialized project management and document tracking tools. Regular training and staying updated on regulatory changes are also essential to ensure submissions are accurate and compliant.

What does a Regulatory Submissions Coordinator do?

A Regulatory Submissions Coordinator is responsible for preparing, reviewing, and submitting regulatory documents to health authorities to ensure compliance with local and international regulations. They work closely with cross-functional teams to gather the necessary information, ensure accuracy, and meet submission deadlines for product approvals or clinical trials. This role also tracks submission status, manages documentation, and communicates with regulatory agencies as needed. Strong attention to detail and knowledge of regulatory guidelines are essential for success in this position.

What is the difference between Regulatory Submissions Coordinator vs Regulatory Affairs Associate?

AspectRegulatory Submissions CoordinatorRegulatory Affairs Associate
CredentialsBachelor's degree in life sciences or related field; certifications like RAC are a plusBachelor's degree in life sciences; certifications like RAC are common
Work EnvironmentPharmaceutical or biotech companies, regulatory departmentsRegulatory teams within pharma, biotech, or medical device companies
Employer & Industry UsageUsed in industries requiring submission of regulatory documentsBroader role involving compliance and regulatory strategy
Search & Comparison IntentOften compared for roles focused on submission processesMore strategic, but related in regulatory career path

The Regulatory Submissions Coordinator primarily focuses on preparing, reviewing, and submitting regulatory documents to agencies. The Regulatory Affairs Associate has a broader role, including compliance, strategy, and communication with regulatory bodies. Both roles require similar credentials and work in similar environments, but the Coordinator is more specialized in submission processes.

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Regulatory Submissions Coordinator jobs near you
Infographic showing various Regulatory Submissions Coordinator job openings in the United States as of May 2026, with employment types broken down into 2% As Needed, 84% Full Time, 10% Part Time, 1% Temporary, and 3% Contract. Highlights an 87% Physical, 1% Hybrid, and 12% Remote job distribution, with an average salary of $69,128 per year, or $33.2 per hour.
Experienced Regulatory Submissions Coordinator

Experienced Regulatory Submissions Coordinator

Medpace, Inc.

Bristol, ME

Other

Medical, PTO

Posted 17 days ago

Medpace rating

8.4

Company rating: 8.4 out of 10

Based on 8 frontline employees who took The Breakroom Quiz

14th of 56 rated research

Job description

Job Summary

We are currently seeking a full-time, office based Regulatory (Study Start up) Submissions Coordinator to join our Clinical Operations team in the Seoul office. This role is a vital part of the team to accomplish tasks and projects that are instrumental to the company's success. If you are interested in an exciting career where you can use your expertise and develop and grow your career even further, then this is the opportunity for you.  

Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team.

Responsibilities
  • Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials;
  • Prepare, review, and submit to Regulatory Agencies (MFDS) and Ethics Committees
  • Communicate with global study teams and personnel on study progress;
  • Ability to effectively identify risks to site activations and mitigate as necessary;
  • Provide expertise and guidance to global study teams in ethics and regulatory submissions;
  • Review and finalize essential documents required for site activation;
  • Act as a main contact for Ethical and Regulatory submission-related activities;
  • Direct contact with investigative sites during the study start up and activation process;
  • Ensure submissions comply with applicable regulations and guidance documents;
  • Advise sponsors on changing regulations and compliance requirements; and
  • Track submissions and ensure timely filing of documents.
Qualifications
  • Bachelor's degree in the science field or equivalent combination of education and experience;
  • Preferred at least 2 years of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site;
  • Experience in preparing and submitting regulatory applications and Ethics Committees
  • Excellent organization and communication skills;
  • Knowledge of Microsoft Office;
  • Knowledge of ICH - GCP guidelines and regulatory guidelines 
  • Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries; and
  • Proactive approach to role with ability and willingness to learn and be challenged.
Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

  • Flexible work environment 
  • Competitive compensation and benefits package
  • Competitive PTO packages
  • Structured career paths with opportunities for professional growth
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives

Awards

  • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Employment Type: OTHER
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About Medpace

Sourced by ZipRecruiter

Medpace is a globally recognized clinicial contract research organization (CRO) based in Cincinnati, OH, in the United States. Established in 1992, it operates in the healthcare sector, providing scientifically-driven outsourcing solutions for the development of drugs and medical devices. It offers comprehensive services like full-service clinical development services, regulatory affairs management, clinical pharmacology, data management, statistical analysis, and medical writing. By applying a scientifically-driven, therapeutically-focused, and patient-centric approach, Medpace's mission is to accelerate the global development of safe and effective medical therapies.

Industry

Medical equipment and supplies manufacturing

Company size

1,001 - 5,000 Employees

Headquarters location

Cincinnati, OH, US

Year founded

1992

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