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Regulatory Associate Jobs (NOW HIRING)

NxT Level

Associate, FDA Regulations - DC

Washington, DC · On-site

$365K/yr

FDA Regulatory Associate - Health & Life Sciences Practice | Washington, DC Our client, a nationally recognized law firm with a strong commitment to inclusivity, innovation, and well-being, is ...

Lancesoft

USA_Regulatory Associate - Level 3

Warren, NJ · On-site

$47 - $49.15/hr

Regulatory Associate Pay Rate $47.00 49.15/hr on W2 Location: Warren, NJ 07059 Duration: 12 Months Day Shift: 8 am - 5 PM Regulatory Affairs Senior Associate The purpose of this role is to execute ...

System One

USA_Regulatory Associate - Level 3

Warren, NJ · On-site

$49.15/hr

USA_Regulatory Associate - Level 3 Location: Warren, NJ Type: 12-month contract Compensation: $49.15 hourly Work Model: Hybrid - 2-3 days onsite Hours: 8am-5PM Overview : The purpose of this role is ...

5 Legal

Corporate Regulatory Associate

Washington, DC · On-site

Am Law top 100 and ranked a Top 10 M&A firm across all industries is seeking a mid-level associate to join their Fintech practice. The ideal candidate will have 2-6 years of regulatory and payments ...

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Regulatory Associate information

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How much do regulatory associate jobs pay per hour?

As of Aug 4, 2026, the average hourly pay for regulatory associate in the United States is $32.21, according to ZipRecruiter salary data. Most workers in this role earn between $24.52 and $38.22 per hour, depending on experience, location, and employer.

What does a regulatory associate do?

As a regulatory associate or regulatory affairs associate, your job is to coordinate compliance with internal—and occasionally external—regulations. This work involves checking each inspection review for accuracy, using safety data sheets (SDS), gathering and compiling documentation for products, and submitting material for license renewals and registrations. In this role, you often create management templates, study existing report documents, oversee the collection of consent forms, and audit the company for any sign of regulatory noncompliance. Some regulatory associates frequently travel to perform audits at various locations. Depending on the industry, you may have additional tasks that involve meeting state or federal guidelines.

Is regulatory associate high paying?

Regulatory associates typically earn competitive salaries that vary by industry, location, and experience level. Entry-level positions may have moderate pay, while experienced professionals with certifications and specialized knowledge can earn higher salaries, especially in regulated industries like pharmaceuticals or finance.

What is the difference between Regulatory Associate vs Compliance Specialist?

AspectRegulatory AssociateCompliance Specialist
Required CredentialsBachelor's degree in life sciences, regulatory affairs, or related field; certifications like RAC are a plusBachelor's degree in law, business, or related; certifications like CCEP may be relevant
Work EnvironmentPharmaceutical, biotech, or medical device companies; regulatory departmentsCorporate compliance departments across various industries, including healthcare and finance
Employer & Industry UsageUsed in regulated industries to prepare and submit regulatory documentsUsed to ensure company adherence to laws and regulations, often involving audits and policy development

The Regulatory Associate primarily focuses on preparing and managing regulatory submissions within life sciences industries, while the Compliance Specialist ensures ongoing adherence to laws and regulations across various sectors. Both roles require similar educational backgrounds and certifications, but their core responsibilities and work environments differ slightly, with Regulatory Associates working more directly with regulatory agencies and Compliance Specialists focusing on internal compliance processes.

What are some common challenges regulatory associates face when working with cross-functional teams?

Regulatory Associates often work closely with teams from R&D, quality assurance, clinical, and legal departments to ensure compliance throughout product development and approval processes. A common challenge is navigating differing priorities and timelines among these groups, which requires strong communication and organizational skills. Additionally, Regulatory Associates must interpret and clarify complex regulatory requirements to various stakeholders, ensuring everyone is aligned and informed. Building collaborative relationships and proactively addressing potential misunderstandings are key to overcoming these challenges.

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

To thrive as a Regulatory Associate, you need strong attention to detail, knowledge of regulatory guidelines (such as FDA or EMA), and a relevant degree in life sciences or a related field. Familiarity with regulatory submission systems, document management tools, and electronic common technical document (eCTD) software is typically required. Excellent organizational skills, communication abilities, and the capacity to manage deadlines make candidates stand out. These skills ensure accurate regulatory submissions, compliance with evolving regulations, and effective collaboration across teams, all of which are crucial for product approvals and market access.
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Regulatory Associate jobs near you
Infographic showing various Regulatory Associate job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 69% Full Time, 28% Part Time, 1% Temporary, and 1% Contract. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution, with an average salary of $66,992 per year, or $32.2 per hour.

Research Regulatory Associate I

Urology San Antonio

San Antonio, TX

Other

Re-posted 24 days ago

Job description

JOB SUMMARY

The Research Regulatory Associate I supports clinical research activities through the development of protocol-specific documents and reports for research activities from initial submission through study closure. The primary focus for this position is on the development, submission, maintenance, filing, archival, and reporting of regulatory documents to achieve and maintain compliance with all internal, external, and federal policies and regulations involving the research of human participants. In addition, this position also provides regulatory guidance and direction to internal clinical research programs and staff to ensure compliance with all applicable policies, procedures, and regulations.

DUTIES AND ESSENTIAL JOB FUNCTIONS

  • Prepares, facilitates, and coordinates the process for accurate and timely submission of Institutional Research Board (IRB) applications for protocol revisions or amendments to reflect any new treatment procedures, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or dual enrollment to additional studies for IRB approved protocols as required by federal regulations and internal policy.
  • Ensures that the research site follows standard operating procedures, sponsor/CRO requirements, Food and Drug Administration (FDA) regulations, ICH guidelines, and good clinical practices pertaining to the conduct of clinical pharmaceutical and device protocols.
  • Safeguards prior to sending to the IRB that all documents are complete and that the submission packet meets the IRB's submission requirements.
  • Maintains subject and document confidentiality, understands, and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration, good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures.
  • Responses and assists with queries from the IRB, Sponsor, and other committees.
  • Produces error-free written documents and reports, such as cover letters, notes-to-file, and memos.
  • Obtains the Sponsor's approval for the consent form prior to submission to the IRB.
  • Coordinates the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state, and local agencies governing biomedical research.
  • Facilitates and coordinates the timely and accurate submission of regulatory documents (hard copies and electronic binders) and IRB submissions by collaborating with research nurses, clinical research coordinators, and investigators to prepare regulatory documents.
  • Accurately files and maintains all necessary logs within the regulatory binder(s), assists in and manages the archival of clinical trial documents/records. Tracks workload and status of pending protocols and associated supporting documents to provide efficient customer service to the Research team.
  • Interacts with internal and external personnel, including but not limited to physicians, nurses, research staff members, administration staff, industry sponsor representatives, IRBs, central laboratory/imaging personnel, and clinical trial patients, and attends site initiation visits. Oversees the QA initiatives for the department to support research staff and leaders during Sponsor and FDA audits.
  • Ensures all regulatory requirements are met, including requirements for trial registration, results, and reporting in a timely manner consistent with federal regulations.
  • Coordinates multiple projects with competing priorities and deadlines, as needed, based on clinical trial protocol directives and study volume.
  • Assists with all other duties as assigned

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