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Regulatory Submission Jobs (NOW HIRING)

Regulatory Submissions Management and Operations for Janssen R&D Project Goal (Mandatory): The management and delivery of regulatory submissions to global health authorities required to support the ...

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Regulatory Submission information

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$40.5K

$95.4K

$138.5K

How much do regulatory submission jobs pay per year?

As of Sep 2, 2026, the average yearly pay for regulatory submission in the United States is $95,411.00, according to ZipRecruiter salary data. Most workers in this role earn between $74,500.00 and $112,000.00 per year, depending on experience, location, and employer.

What is a regulatory submission?

A Regulatory Submission job involves preparing, compiling, and submitting documents to regulatory authorities to gain approval for products, such as pharmaceuticals, medical devices, or biotechnology innovations. Professionals in this role ensure that submissions comply with regulatory requirements, guidelines, and timelines. They work closely with cross-functional teams, including regulatory affairs, clinical, and quality assurance teams, to gather necessary data and documentation. The role requires strong attention to detail, knowledge of global regulatory standards, and effective communication skills to liaise with regulatory agencies.

What are the primary day-to-day responsibilities of someone working in regulatory submission?

A professional in Regulatory Submission is typically responsible for compiling, reviewing, and submitting regulatory documents to agencies such as the FDA or EMA to support product approvals or ongoing compliance. Their daily tasks often include coordinating with cross-functional teams (such as clinical, quality, and legal departments), tracking deadlines, and maintaining documentation to meet regulatory standards. They must closely monitor regulatory changes and ensure submissions are updated accordingly. This role may also oversee the management of electronic submission systems and address queries or deficiencies from regulatory authorities. Overall, the position offers regular opportunities to collaborate and play a pivotal part in a company's product development lifecycle.

What are the key skills and qualifications needed to thrive in the regulatory submission position, and why are they important?

To thrive as a Regulatory Submission professional, you need a solid understanding of regulatory requirements, attention to detail, and experience in preparing, compiling, and submitting documents to regulatory authorities—often requiring a degree in life sciences or a related field. Familiarity with submission management systems (such as eCTD or Veeva Vault), strong document management skills, and sometimes certifications like RAPS are valuable assets. Strong organizational abilities, effective written communication, and the capacity to collaborate cross-functionally distinguish standout candidates. These competencies ensure timely, accurate, and compliant submissions, which are vital for regulatory approval and the successful progress of products to market.

More about Regulatory Submission jobs

What are the most commonly searched types of Regulatory Submission jobs?

The most popular types of Regulatory Submission jobs are:

What states have the most Regulatory Submission jobs?

States with the most job openings for Regulatory Submission jobs include:

Infographic showing various Regulatory Submission job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 88% Full Time, 9% Part Time, and 2% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $95,411 per year, or $45.9 per hour.

Regulatory Submission Publishing Specialist

System One

Pleasanton, CA • Remote

$23.46 - $34.98/hr

Contractor

Medical, Dental, Vision, Life, Retirement

Posted 25 days ago


Job description

Job Title: Regulatory Submission Publishing Specialist Location: Pleasanton, CA Type: Contract Compensation: $23.46 - $34.98 Work Model: Remote – offsite Hours: Flexible days, part time (24-32 hours/week) Security Clearance: Not specified

Responsibilities

  • Coordinate the submission and publishing process for regulatory registrations, primarily for the US and EU markets.
  • Prepare submissions in accordance with external health authority guidelines, and internal standard practices.
  • Prepare and format documents according to publication and submission requirements.
  • Liaise with project leads, project teams, and regulatory bodies to gather necessary documents and ensure smooth submission processes.
  • Maintain tracking systems to monitor the status and deadlines of all submissions.
  • Support the management of publication databases and repositories.
  • Collaborate with Regulatory Leads and Managers to ensure submission deliverables meet requirements are fulfilled.
Requirements
  • Minimum of 5 years of experience in regulatory submissions within the diagnostics or pharmaceutical sector.
  • Bachelor’s degree in Life Sciences, Regulatory Science, Quality, or related field, or equivalent professional experience.
  • Strong attention to detail and organizational skills.
  • Excellent written and verbal communication skills.
  • Proficiency with industry-standard publishing and submission software and tools (Microsoft Word, Acrobat Pro, ISI Toolbox, Veeva RIMS, US Health Authority portals).
  • Ability to manage multiple projects and meet deadlines in a fast-paced environment.
  • Familiarity with regulatory guidelines such as FDA, EMA, ICH, GxP, and publication ethics.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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About System One

Sourced by ZipRecruiter

System One helps employers get work done more efficiently and economically without compromising quality. Over our 35+ year history, we've helped connect thousands of talented people with innovative companies. The excitement of a perfect fit motivates us every single day.

Industry

Business consulting services and recruiting and staffing services

Company size

5,001 - 10,000 Employees

Headquarters location

Pittsburgh, PA, US