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Entry Level Regulatory Submission Publisher Jobs

Taiho Oncology

$86K - $102K/yr

... regulatory affairs dossier publishing activities ... The activities include document and submission preparation and review, communicating with RA staff ...

Icon plc

Senior Regulatory Project Manager

Reading, PA · On-site

Senior Regulatory Project Manager ICON is a global healthcare intelligence and clinical research ... submissions, regulatoryoperationsor publishing. * Strong project management skills * Fluency in ...

ICON

Senior Regulatory Project Manager

Blue Bell, PA · On-site +1

A relevant educational background in a life-sciences discipline Some previous experience in submissions, regulatory operations or publishing. * Strong project management skills * Fluency in English

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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 22, 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 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.

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 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 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.

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Entry Level Regulatory Submission Publisher jobs near you
Infographic showing various Entry Level Regulatory Submission Publisher job openings in the United States as of August 2026, with employment types broken down into 78% Full Time, 11% Part Time, and 11% Contract. Highlights an 89% In-person, and 11% Hybrid job distribution, with an average salary of $62,196 per year, or $29.9 per hour.

Manager, Regulatory Publishing

KMR Search Group

White Plains, NY • On-site

$80K - $110K/yr

Full-time

Re-posted 27 days ago

Job description


Responsible for managing Regulatory Publishing staff who format and publish electronic documents, build Regulatory submission deliverables such as INDs, CTAs, BLAs, MAAs, including their amendments and supplements, in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
Job Duties
• Manages staff who electronically format, publish electronic documents and builds Regulatory submission deliverables. Ensures quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures.
• Provides guidance to multidisciplinary teams on developing submission structure strategies in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc)
• Provides guidance on good documentation and submission practices
• Assist with developing and maintaining Regulatory document processing and Regulatory submission publishing standards and procedures in accordance with all applicable Regulatory regulations, guidance, and specifications.
• Identifies regulatory system enhancement needs or technical issues and works closely with systems and technical support staff to identify, develop, and implement solutions
• Assists with regulatory inspection activities
• Provide Document authoring template training.
• Maintains Authoring Template Library and works with cross-functional teams to develop and maintain templates
• Collaborates with vendors who support Regulatory operations related tasks.
• Communicates the need for additional resources to management as needed.
• Requires to function as a contributor as needed.
• Provides support and backup to management as needed.
Job Requirements
• Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc)
• Working knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems, document authoring templates, document publishing tools, publishing systems, eCTD validation and viewing tools and XML are required.

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