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Entry Level Regulatory Submission Publisher Jobs

krg technology inc

Project Manager

Upper Gwynedd, PA

... on regulatory submissions Familiar with 21 CFR part 11, GXP and other Life Sciences regulations Technical Experience Experience with LIQUENT Insight publisher, Veeva platform strongly preferred ...

krg technology inc

Project Manager

Rahway, NJ · On-site

... on regulatory submissions Familiar with 21 CFR part 11, GXP and other Life Sciences regulations Technical Experience Experience with LIQUENT Insight publisher, Veeva platform strongly preferred ...

Cardinal Health

$31.50 - $40.41/hr

... regulatory submission content. Location Remote Responsibilities * Support the development ... Working knowledge of Adobe Acrobat for document editing, formatting, and publishing. * Proactive ...

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Entry Level Regulatory Submission Publisher information

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How much do entry level regulatory submission publisher jobs pay per hour?

As of Aug 5, 2026, the average hourly pay for entry level regulatory submission publisher in the United States is $29.90, according to ZipRecruiter salary data. Most workers in this role earn between $23.08 and $34.38 per hour, depending on experience, location, and employer.

What are the typical daily tasks for an entry level regulatory submission publisher, and how do they contribute to the overall submission process?

As an Entry Level Regulatory Submission Publisher, your daily tasks will typically include formatting and compiling regulatory documents, converting files to compliant electronic formats (such as eCTD), and ensuring that all submission components meet agency requirements. You will work closely with regulatory affairs teams, document authors, and quality control to coordinate timelines and address any technical issues that arise during the publishing process. Your attention to detail directly contributes to the success of regulatory submissions by ensuring accuracy, compliance, and timely delivery to regulatory authorities.

What is the difference between Entry Level Regulatory Submission Publisher vs Regulatory Affairs Associate?

AspectEntry Level Regulatory Submission PublisherRegulatory Affairs Associate
CredentialsBachelor's degree, training in submission processesBachelor's degree, often with additional certifications in regulatory affairs
Work EnvironmentDocument management, submission preparation, cross-functional teamsRegulatory strategy, compliance monitoring, communication with authorities
Industry UsagePharmaceutical, biotech, medical device companiesPharmaceutical, biotech, medical device companies

While both roles operate within regulatory departments, the Entry Level Regulatory Submission Publisher primarily focuses on preparing and managing submission documents, whereas the Regulatory Affairs Associate handles broader regulatory strategies and compliance activities. The publisher role is more document-centric, often requiring detailed knowledge of submission formats, while the associate role involves more communication with regulatory agencies and strategic planning.

What are the key skills and qualifications needed to thrive as an entry level regulatory submission publisher, and why are they important?

To thrive as an Entry Level Regulatory Submission Publisher, you need attention to detail, organizational skills, and a bachelor's degree in life sciences or a related field. Familiarity with regulatory submission software (such as eCTD tools), document management systems, and basic knowledge of ICH guidelines are typically required. Strong communication, time management, and teamwork skills help ensure accuracy and timely delivery of submissions. These abilities are crucial for maintaining compliance, meeting tight regulatory deadlines, and supporting successful product approvals.

What does an entry level regulatory submission publisher do?

An Entry Level Regulatory Submission Publisher is responsible for preparing, formatting, and submitting regulatory documents to health authorities such as the FDA or EMA. They work closely with regulatory affairs teams to ensure that all documents meet technical and formatting requirements, comply with regulations, and are submitted on time. This role often involves using specialized software to assemble electronic submissions, reviewing documents for accuracy and completeness, and tracking submission progress. It is an essential position in pharmaceutical and biotechnology companies to ensure regulatory compliance and timely product approvals.
More about Entry Level Regulatory Submission Publisher jobs
What are the most commonly searched types of Regulatory Submission Publisher jobs? The most popular types of Regulatory Submission Publisher jobs are:
What states have the most Entry Level Regulatory Submission Publisher jobs? States with the most job openings for Entry Level Regulatory Submission Publisher jobs include:
What job categories do people searching Entry Level Regulatory Submission Publisher jobs look for? The top searched job categories for Entry Level Regulatory Submission Publisher jobs are:
Entry Level Regulatory Submission Publisher jobs near you
Infographic showing various Entry Level Regulatory Submission Publisher job openings in the United States as of July 2026, with employment types broken down into 83% Full Time, and 17% Part Time. Highlights an 100% In-person job distribution, with an average salary of $62,196 per year, or $29.9 per hour.

Research Regulatory Coordinator

Oneoncology

Lakewood, CO • On-site

Full-time

Medical, Dental, Vision

Posted 9 days ago

OneOncology rating

7.8

Company rating: 7.8 out of 10

Based on 17 frontline employees who took The Breakroom Quiz

Job description

Why Join Us?

At United Urology Group, our employees are at the heart of our mission and have incredible opportunities to impact our patients' lives with their urologic care.

We foster a culture that thrives on compassion, teamwork, integrity, and diversity, all of which start with our staff! We deliver a cohesive approach to urologic care that provides patients with access to experienced specialists, a superb team of healthcare professionals, and the most advanced technology for patient treatments and therapies. We offer competitive salaries and a great work/life balance: enjoy your weekends! UUG offers outstanding benefits, including tuition reimbursement, health, dental, and vision insurance, corporate discounts, and much more!

Job Description:

The Clinical Research Regulatory Coordinator will support clinical research teams (research physicians, research nurses, research coordinators etc.) in research efforts by facilitating the study start-up approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.

Theywill be responsible for ensuring that all research studies are compliant with regulations as well asmaintainingaccurate and up-to-date regulatory files.Theywill serve as a central regulatory resource for staff conducting clinical research. This position reports to the Director ofClinical Research.

Responsibilities:

  • Works closely with Investigators and Research Staff on new studies to ensure timely, accurate submissions to theInstitutional Review Boards (IRB),Institutional Biologic Committees(IBC)and sponsors.

  • Understands current regulatory requirements and ensures a smooth submission process to minimize delays to study initiation.

  • Works with multiple IRBs and understands their submission process and requirements.

  • Works with multiple IBCs and assist with settingup new IBC Committee'sand understands their submission process and requirements.

  • New study submissions to the regulatory authorities, IRB,IBCand sponsors including initial submissions, amendments, safety reports, deviations, etc. to ensure timely, accurate submissions.

  • Maintains staff credentials including the CV, licenses,Financial Disclosure Forms (FDF), etc.

  • Serves as primary IRB& IBCcontact & provides institutional authorization for new submissions.

  • Tracks each protocol through the IRB/IBC/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease the delay in the approval process.

  • Works with sponsors to ensure all proper regulatory documents are approved and that all documents, access toCase Report Form's (CRF)and databases, study required portals, monitoring/auditing requirements have been completed prior to the start of a study.

  • Will produce, as applicable, and maintain regulatory binders prior to studies starting with all required documents and ensure dedicated electronic study folder is current.

  • Obtains and completes all required documents for new submissions, exemption requests, compassionate uses, amendment applications, continuing review, and closure activities.

  • Reviews informed consents for institutional languageadditions.

  • Remains informed of current federal, state, and local regulations regarding clinical research and communicates anychanges to the study team.

  • Maintains working knowledge of current protocols and internalStandard Operating Procedures (SOP).

  • Participates in required teleconferences, on-site meetings, and off-site investigator meetings, as required.

  • Documents and tracks research training of investigators and research staff.

  • Additional responsibilities as assigned to help drive our mission.

Requiredor PreferredQualifications:

  • High School Diploma Required.

  • AA/AS or BA/BS degree preferred (or equivalent combination of experience and education).

  • ACRP/SOCRA (or equivalent) certification preferred.

  • Two (2) years minimum of directly related experience, or equivalent combination of education and experience.

  • Current GCP Certification.

KeyCompetencies:

  • Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines.

  • Excellent communication skills and superb attention to detail.

  • Excellent interpersonal skills and customer service focus is required.

  • Strong writing and organizational skills.

  • Able to work in a fast-paced environment with flexibility and autonomy.

  • Must be able to prioritize tasks on a daily basis.

  • Computer knowledge in Microsoft Windows applications (including Word, Outlook, Excel, PowerPoint, Publisher),Clinical Trial Master Systems and familiarity with Electronic Data Capture Systems.

  • Attendance is an essential job function.

Physical Requirements:

  • Large percent oftime spentperforming computer-basedand paperbasedwork is required.

  • Regularly required to sit and stand for extended periods.

  • Involves standing, sitting, walking, bending, stooping, and twisting.

  • Requires full range of body motion, including manual and finger dexterity and eye-hand coordination.

  • Occasionally lift andcarryitems weighing up to25lbs.

Job Type: Full-Time
Actual compensation offered to candidates is based on work experience, education, skill level, and geographic location. Compensation may vary depending on the state or region in which the position is located, in accordance with applicable laws.
This position has no close date. Applications will be accepted until an offer has been extended
and accepted.
Equal Opportunity Employer: Our Practice is an equal opportunity employer. We do not
discriminate based on race, color, religion, age, sex, national origin, disability, veteran
status, or sexual orientation.
The successful candidate(s) for any UUG position will be subject to a pre-employment
background check.

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