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Regulatory Operations Manager Jobs (NOW HIRING)

Kalshi Inc

Compliance, Regulatory Operations

New York, NY · On-site

$100K - $175K/yr

... operations regulator-ready as the business scales. You will own a broad set of day-to-day ... Build and manage employee compliance training, certification, and attestation processes across the ...

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$118.5K

How much do regulatory operations manager jobs pay per year?

As of Sep 12, 2026, the average yearly pay for regulatory operations manager in the United States is $63,456.00, according to ZipRecruiter salary data. Most workers in this role earn between $41,000.00 and $77,500.00 per year, depending on experience, location, and employer.

What does a regulatory operations manager do?

A Regulatory Operations Manager oversees the processes and systems required to ensure an organization complies with all regulatory requirements, especially in highly regulated industries like pharmaceuticals, finance, or healthcare. Their responsibilities often include managing the submission of documents to regulatory agencies, ensuring accurate record-keeping, developing compliance strategies, and coordinating with various internal departments. They play a critical role in maintaining regulatory standards and facilitating timely approvals for product launches or business activities.

What are the key skills and qualifications needed to thrive as a regulatory operations manager?

To thrive as a Regulatory Operations Manager, you need expertise in regulatory compliance, project management, and a relevant degree in life sciences or a related field. Familiarity with electronic document management systems (EDMS), regulatory submission platforms like eCTD, and knowledge of global regulatory requirements are typically required. Strong attention to detail, organizational skills, and effective cross-functional communication set outstanding professionals apart in this role. These competencies are crucial for ensuring timely, accurate regulatory submissions and facilitating seamless collaboration within regulatory and cross-functional teams.

How does a regulatory operations manager collaborate with cross-functional teams to ensure timely regulatory submissions?

A Regulatory Operations Manager works closely with regulatory affairs, clinical, quality assurance, and project management teams to coordinate the preparation, review, and submission of regulatory documents. They serve as a central point of contact, facilitating communication and aligning timelines to ensure all required materials are gathered and compliant with regulatory standards. By organizing regular meetings and utilizing document management systems, they help streamline the submission process and proactively identify and resolve potential bottlenecks.

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

AspectRegulatory Operations ManagerRegulatory Affairs Specialist
CredentialsTypically requires a bachelor’s degree in life sciences, regulatory affairs, or related field; certifications like RAC are commonSimilar credentials; often holds a bachelor’s degree and may pursue regulatory certifications
Work EnvironmentManages regulatory processes, documentation, and compliance within organizations, often overseeing teamsFocuses on preparing and submitting regulatory documents, ensuring compliance with regulations
Industry UsageUsed across pharmaceutical, biotech, and medical device companies for operational oversightCommonly found in similar industries, focusing on regulatory submissions and communication with authorities

The Regulatory Operations Manager oversees the regulatory process, managing teams and ensuring compliance, while the Regulatory Affairs Specialist concentrates on preparing submissions and liaising with regulatory agencies. Both roles require similar credentials and are vital in regulated industries, but their focus areas differ slightly.

Is regulatory compliance a stressful job?

Regulatory Operations Managers often find regulatory compliance to be demanding due to strict deadlines, detailed documentation, and the need to stay current with evolving regulations. The role requires strong attention to detail, organizational skills, and the ability to manage multiple priorities, which can contribute to work-related stress.

Is regulatory operations a good career path?

Regulatory operations is a viable career path for professionals interested in compliance, documentation, and process management within regulated industries such as pharmaceuticals, biotech, and healthcare. It often requires strong attention to detail, knowledge of regulatory requirements, and proficiency with tools like document management systems. The role offers opportunities for advancement and specialization, with demand driven by industry regulations and compliance needs.
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Regulatory Operations Manager jobs near you
Infographic showing various Regulatory Operations Manager 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 $63,456 per year, or $30.5 per hour.

Regulatory Operations Specialist

Savannah, GA • On-site

St. Joseph's/Candler
Health Care and Social Assistance • 1 - 5K employees
Learn more about St. Joseph's/Candlerexternal

$19.28/hr

Full-time

Re-posted 2 days ago

St. Joseph's/Candler Health System rating

7.0

Company rating: 7.0 out of 10

Based on 20 frontline employees who took The Breakroom Quiz

Job description

  • Position Summary

    • The Research Regulatory Specialist is responsible for coordinating the daily activities associated with supporting the regulatory department at the Nancy N. and J.C. Lewis Cancer & Research Pavilion (LCRP). The individual will perform clerical activities including filing, scanning, faxing and documentation management. The individual will be the upkeep of regulatory documentation associated with pharmaceutical and National Cancer Center (NCI) Central Institutional Review Board (CIRB) and the ADVARRA CIRB as appropriate.  The individual will be responsible for safety reporting, updating the LCRP and Georgia Center for Oncology Research and Education (GA CORE) websites, regulatory meeting minutes, bi-weekly research meeting minutes and assisting the manager and regulatory coordinator with additional research related duties. The successful candidate complies with all SJ/C policies, procedures, departmental guidelines, and applicable laws in the conduct of routine activities and the solution of problems; prepares documents for regulatory review, monitoring and auditing.   

      Ensures that all regulatory documents are in compliance and maintained in accordance with Good Clinical Practice (GCP), Department of Health and Human Services (DHHS), and the Food and Drug Administration (FDA) guidelines.

      Works independently to assure compliance with the requests of sponsors, SJ/C IRB and internal managers as needed.

      Works with Regulatory and Compliance Manager, the Research Regulatory Coordinator- Lead and the Clinical Research Coordinator (CRC) in scheduling and conducting monitoring visits, responding to monitoring, audit reports and additional research protocol duties as needed.

      Maintains sponsor, investigator and research personnel regulatory communication.

  • Education
    • Associate's Degree - Required
    • Bachelor's Degree - Preferred
  • Experience
    • 1-2 Years of General Healthcare or Legal experience - Preferred
  • License & Certification
    • Good Clinical Practice (GCP) and Human Protections Training  - Preferred
  • Core Job Functions
    • Assist in maintaining regulatory master files for each clinical trial and assist in preparing documents for IRB and/or sponsor review.
    • Ensure all study specific Financial Disclosure Forms (FDFs), annual FDFs and safety reports are prepared, filed, completed, and submitted accurately in a timely manner. Other trial-related documents are processed in a timely manner. Responsible for delivery and pickup of regulatory documents between site locations and retrieving provider and staff signatures.
    • Maintain research staff trainings and credentialing using a tracking system.
    • Coordinate various forms of communication, including but not limited to telephone, email and responding to the Regulatory & Compliance Manager and Regulatory Coordinator. Accurately managing documents in accordance with appropriate clinical trial. Responsible for ordering supplies and scheduling the conference room for the office.
    • Maintain historical and current documents for clinical trials utilizing both CREDIT & Florence software and others as appropriate. Maintain the LCRP website and GA CORE website to ensure all active trials are visible to the community. Ensure appropriate research sites are activated within the CREDIT system. 

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