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How much do regulatory operations associate jobs pay per hour?

As of Sep 12, 2026, the average hourly pay for regulatory operations associate in the United States is $26.24, according to ZipRecruiter salary data. Most workers in this role earn between $17.79 and $30.29 per hour, depending on experience, location, and employer.

What is a regulatory operations associate?

Regulatory Operations Associates are professionals who support the preparation, submission, and management of documents required by regulatory agencies for product approvals, especially in industries like pharmaceuticals, biotechnology, and medical devices. They ensure that submissions comply with legal and regulatory standards, track submission timelines, and often use specialized software for document management. Their work is crucial for maintaining compliance and facilitating smooth communication between their company and regulatory authorities. Additionally, Regulatory Operations Associates may coordinate with cross-functional teams to gather necessary documentation and maintain up-to-date records.

How does a regulatory operations associate typically collaborate with cross-functional teams within an organization?

Regulatory Operations Associates frequently work alongside regulatory affairs, quality assurance, clinical, and legal teams to ensure that all submissions and documentation comply with industry standards and governmental regulations. They coordinate the collection, formatting, and timely submission of regulatory documents, often acting as a liaison between departments to resolve any discrepancies or gather necessary information. Effective communication and organization are key, as the role requires balancing multiple deadlines and adapting to evolving requirements set by regulatory authorities.

What are the key skills and qualifications needed to thrive as a regulatory operations associate, and why are they important?

To excel as a Regulatory Operations Associate, you generally need a background in life sciences or a related field, strong attention to detail, and experience with regulatory documentation processes. Familiarity with electronic document management systems (EDMS), eCTD publishing tools, and knowledge of regulatory submission standards are typically required. Excellent organizational skills, communication, and the ability to manage multiple deadlines help candidates stand out. These competencies ensure accurate, timely regulatory submissions and compliance, which are critical for product approvals and organizational success.

What is the difference between Regulatory Operations Associate vs Regulatory Affairs Specialist?

AspectRegulatory Operations AssociateRegulatory Affairs Specialist
Required CredentialsBachelor's degree, familiarity with regulatory processesBachelor's degree, often with certifications in regulatory affairs
Work EnvironmentSupportive regulatory teams, administrative tasksStrategic planning, compliance management
Employer & Industry UsagePharmaceutical, biotech, healthcare companiesPharmaceutical, medical device, biotech sectors
Common Search & ComparisonYesNo

The Regulatory Operations Associate typically handles administrative and operational support within regulatory teams, focusing on document management and submission processes. In contrast, the Regulatory Affairs Specialist is more involved in strategic compliance, ensuring products meet regulatory standards. Both roles are essential in regulated industries like pharma and biotech, but they differ in scope and responsibilities.

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Regulatory Operations Associate jobs near you
Infographic showing various Regulatory Operations Associate job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 79% Full Time, 17% Part Time, 1% Temporary, 1% Contract, and 1% Nights. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $54,588 per year, or $26.2 per hour.

Regulatory Operations Documentation Specialist

Florham Park, NJ • Remote

System One
Business Consulting Services • 5 - 10K employees
Learn more about System Oneexternal

$31 - $54/hr

Contractor

Medical, Dental, Vision, Life, Retirement

Re-posted 21 days ago

Job description

Job Title: Regulatory Operations Documentation Specialist Location: Florham Park, New Jersey Type: 12-month Contract Compensation: $31.00 – $54.00 per hour Contractor Work Model: Remote Hours: 40.0 hours per week

Overview This role will support the Regulatory Operations team with the preparation of submission related documentation for electronic submission. The scope of this role includes assisting in document formatting, remediation and quality control (QC) of documentation for submissions to Health Authorities. The role also involves archiving correspondence with Health Authorities, as well as managing documents stored at or retrieved from offsite facilities. The ideal candidate will bring experience with Microsoft Word, Adobe Acrobat, and Veeva RIM.

Responsibilities

  • Support document formatting and QC in alignment with standards for submission-related materials.
  • Assist in the remediation and QC of PDF documents, including bookmarking and hyperlinking to ensure regulatory-compliant electronic files.
  • Assist in ensuring all communications with health authorities are properly archived within the company’s system and adhere to applicable regulatory guidelines.
  • Assist the archiving and retrieval of documents from offsite storage facilities.
  • Provide ongoing support to the Regulatory Operations team.
Requirements
  • High school degree required; Associate’s degree preferred.
  • Pharmaceutical industry experience is a plus, but not required
  • Proficient in MS Office and Acrobat Adobe.
  • Experience with ISI Toolbox or equivalent software packages
  • Experience with database systems; Veeva is a plus.
  • High level of attention to detail and accuracy in work.
  • Effective time management and organizational skills.
  • Strong written and verbal communication skills.
  • Able to work within a high-performance, collaborative team environment.

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.

#M- #LI-

Ref: #568-Clinical

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About System One

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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

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