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Remote Regulatory Submission Publisher Jobs (NOW HIRING)

Altimmune

Director, US Regulatory Affairs

Morristown, NJ · On-site +1

$154K - $204K/yr

Depending upon location, this role will be hybrid or remote and will require some travel as ... Manages the preparation and submission of formal regulatory meeting requests and briefing packages ...

Jj

Senior Regulatory Affairs Program Lead (OTTAVA)

Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America, Remote ... Experience with medical device regulatory new product submissions required . * A demonstrated track ...

New

IMMY

Regulatory Affairs Associate

Norman, OK · Remote

This is a remote-eligible position, requiring the candidate live within the U.S. Job Purpose The ... Maintaining knowledge of submission requirements and processes for multiple regulatory ...

New

Flourish Research

Regulatory Compliance Specialist I

$24 - $28/hr

Remote FLSA Classification: Non-Exempt Compensation: $24.00-$28.00 per hour Essential Job Functions ... Prepare applicable submission forms and submit updated documents including but not limited to:

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How much do remote regulatory submission publisher jobs pay per hour?

As of Aug 24, 2026, the average hourly pay for remote regulatory submission publisher in the United States is $56.97, according to ZipRecruiter salary data. Most workers in this role earn between $42.07 and $66.59 per hour, depending on experience, location, and employer.

What is a remote regulatory submission publisher?

A Remote Regulatory Submission Publisher is a professional who prepares, formats, and submits regulatory documents to health authorities, such as the FDA or EMA, from a remote location. Their primary responsibility is to ensure that all regulatory submissions comply with current guidelines and technical requirements. They use specialized software to compile, validate, and publish documents, often as part of the drug development process in the pharmaceutical or biotech industries. Working remotely allows them to perform these tasks from anywhere, collaborating virtually with regulatory and project teams.

What are the key skills and qualifications needed to thrive as a remote regulatory submission publisher?

To thrive as a Remote Regulatory Submission Publisher, you need expertise in regulatory submission processes, document management, and a background in life sciences or a related field. Familiarity with eCTD publishing tools (like Lorenz or Veeva Vault), regulatory databases, and understanding of global submission requirements is typically expected. Attention to detail, strong organizational skills, and effective remote communication are crucial soft skills for coordinating with cross-functional teams. These competencies ensure accurate, compliant, and timely submissions to regulatory authorities, which is critical for product approvals and company success.

What are some typical challenges faced by remote regulatory submission publishers, and how can they be effectively managed?

Remote Regulatory Submission Publishers often encounter challenges such as coordinating across multiple time zones, ensuring timely document collection from diverse teams, and maintaining compliance with varying global regulatory requirements. Effective management involves establishing clear communication channels, using collaborative document management systems, and staying updated on submission guidelines for different regions. Proactive organization and regular check-ins with cross-functional teams can help overcome these challenges, ensuring high-quality and compliant submissions.

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

AspectRemote Regulatory Submission PublisherRemote Regulatory Affairs Associate
CredentialsTypically requires a degree in life sciences or related field, with experience in document managementRequires a degree in life sciences, with knowledge of regulatory processes and possibly certification in regulatory affairs
Work EnvironmentPrimarily focused on preparing, formatting, and submitting regulatory documentsInvolves broader regulatory strategy, communication with authorities, and compliance oversight
Industry UsageCommonly employed in pharmaceutical, biotech, and medical device industries for submission tasksUsed across similar industries, with additional responsibilities in regulatory planning and strategy

The Remote Regulatory Submission Publisher mainly handles the preparation and submission of regulatory documents, focusing on formatting and compliance. In contrast, the Remote Regulatory Affairs Associate has a broader role, including regulatory strategy, communication, and compliance oversight. Both roles require relevant life sciences credentials but differ in scope and responsibilities.

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Remote Regulatory Submission Publisher jobs near you
Infographic showing various Remote Regulatory Submission Publisher job openings in the United States as of August 2026, with employment types broken down into 84% Full Time, 3% Part Time, 3% Temporary, and 10% Contract. Highlights an 100% Remote job distribution, with an average salary of $118,493 per year, or $57 per hour.

Director, US Regulatory Affairs

Altimmune

Morristown, NJ • On-site, Remote

$154K - $204K/yr

Full-time

Re-posted 23 days ago

Job description

Workplace Designation:

Depending upon location, this role will be hybrid or remote and will require some travel as business needs dictate.

Summary of Position:

This individual will be responsible for providing strategic regulatory advice and oversight for all of Altimmune's US regulatory applications, including the preparation and management of relevant clinical, nonclinical, advertising, promotional, and labeling aspects of relevant US regulatory submissions, responses, and correspondence. This role will act as the main point of contact and liaison with the US FDA. This position reports to the Vice President, Regulatory Affairs.

Essential Functions:

  • High-level management of regulatory projects as assigned, assistance in the development of regulatory submission timelines, and ensuring execution to meet corporate goals
  • Oversee the timelines, review, and compilation of IND, BLA, NDA, promotional, and lifecycle submissions, including any safety reporting, as required
  • Manages the preparation and submission of formal regulatory meeting requests and briefing packages and coordinates the face-to-face or online meetings with regulatory agencies
  • Plays a key role in the development of regulatory strategy and writing of regulatory submissions
  • Interprets FDA regulations/guidelines governing drugs, devices, and biologics and advises Senior Management on pertinent regulatory intelligence
  • Attends relevant FDA meetings and interfaces with regulatory/competent authorities, negotiating resolution of regulatory issues affecting Altimmune's product development programs
  • Plays a leading role in the development, review, and implementation of departmental SOPs and processes
  • Other duties as assigned.
Job Requirements (essential knowledge, skills, and attributes):
  • Minimum education Bachelor's degree in science, engineering, or a health-related field required with at least 6 years of regulatory experience in the biotech/pharma industry, or a Ph.D., MD, PharmD with at least 6 years of regulatory experience
  • Operational experience in regulatory submissions management, compiling and managing eCTD submissions, and formal correspondence and liaison with regulatory agencies
  • Thorough knowledge of FDA regulations and global regulatory guidelines governing clinical development, clinical trial applications, marketing, and post-approval application submissions. Prior experience reviewing and submitting advertising and promotional materials for drugs and biological products is preferred
  • Excellent planning, organization, and project management skills, including the ability to adjust to rapidly changing priorities and manage multiple projects simultaneously
  • Must be self-motivated with a positive attitude and the ability to work well with others
  • Excellent oral and written communication skills.

Altimmune provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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