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Regulatory Submissions Jobs (NOW HIRING)

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Manager, Regulatory Submissions (Remote)

Chicago, IL · On-site +1

$110K - $150K/yr

Leading and assisting with submissions and correspondence with global regulatory authorities, including 510(k), PMA, De Novo authorizations, IDE, MDR CE marking, UKCA marking, etc. * Establishing ...

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Regulatory Submissions information

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How much do regulatory submissions jobs pay per hour?

As of Jul 14, 2026, the average hourly pay for regulatory submissions in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What are regulatory submissions?

Regulatory submissions are formal documents or packages of information that organizations, such as pharmaceutical or medical device companies, submit to government agencies to obtain approval for products, clinical trials, or changes to existing products. These submissions must comply with specific regulatory requirements and formats, and may include data on safety, efficacy, quality, and manufacturing processes. Common regulatory agencies include the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and others, depending on the region. The process helps ensure that products are safe and effective for public use before they reach the market.

What are some common challenges faced by professionals working in Regulatory Submissions?

Regulatory Submissions professionals often navigate complex and evolving regulations across different regions, which can be challenging when preparing documentation for multiple authorities. Managing tight deadlines, coordinating input from cross-functional teams (such as clinical, quality, and legal departments), and ensuring data accuracy are key aspects of the role. Additionally, adapting to varying submission formats and requirements for each regulatory body demands strong attention to detail and organizational skills. Overcoming these challenges is essential to facilitate timely product approvals and maintain compliance.

What is the difference between Regulatory Submissions vs Regulatory Affairs Specialist?

AspectRegulatory SubmissionsRegulatory Affairs Specialist
Primary RolePreparing, submitting, and managing regulatory documents to authoritiesDeveloping regulatory strategies, ensuring compliance, and liaising with agencies
Required CredentialsTypically degrees in life sciences, certifications like RACSimilar credentials, often with additional experience in regulatory strategy
Work EnvironmentRegulatory departments within pharmaceutical or biotech companiesRegulatory teams across industries, including healthcare and medical devices

While Regulatory Submissions focus on preparing and managing specific documents for approval, Regulatory Affairs Specialists oversee broader compliance strategies and interactions with regulatory agencies. Both roles require similar credentials and often work closely within the same industry, but their scope and responsibilities differ.

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

To thrive in Regulatory Submissions, you need a strong understanding of regulatory guidelines, document management, and scientific or clinical background, often supported by a degree in life sciences or a related field. Familiarity with electronic submission platforms (eCTD), regulatory databases, and tools like Adobe Acrobat and Microsoft Office is typically required. Attention to detail, organizational skills, and effective written and verbal communication set professionals apart in this role. These skills ensure accurate, timely submissions and facilitate compliance with global regulatory requirements, which is critical for product approvals and company success.
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Regulatory Submissions jobs near you
Infographic showing various Regulatory Submissions job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 87% Full Time, 10% Part Time, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.
Experienced Regulatory Submissions Coordinator

Experienced Regulatory Submissions Coordinator

Medpace, Inc.

Bristol, ME

Other

Medical, PTO

Re-posted 4 days ago

Medpace rating

8.5

Company rating: 8.5 out of 10

Based on 9 frontline employees who took The Breakroom Quiz

14th of 59 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

What Medpace employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

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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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