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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Healthcare Regulatory Associate Attorney - Houston Direct Counsel is seeking a Healthcare Regulatory Associate to join a highly respected Am Law firm in Houston. This is an excellent opportunity for ...
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Healthcare Regulatory Associate Attorney - Houston Direct Counsel is seeking a Healthcare Regulatory Associate to join a highly respected Am Law firm in Houston. This is an excellent opportunity for ...
National law firm is seeking to add a Healthcare Litigation/Regulatory Associate to its Dallas office. Associate in this position will be working in the Dental Service Organizations Practice Group ...
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National law firm is seeking to add a Healthcare Litigation/Regulatory Associate to its Dallas office. Associate in this position will be working in the Dental Service Organizations Practice Group ...
UT Southwestern, one of the nation's top Academic Medical Centers, is seeking a dynamic Senior Regulatory Associate in our prestigious Surgical Services department. Requires 3 years related ...
UT Southwestern, one of the nation's top Academic Medical Centers, is seeking a dynamic Senior Regulatory Associate in our prestigious Surgical Services department. Requires 3 years related ...
A global and top 200 Am Law firm seeks an associate to join their Healthcare Team in their Austin office. The ideal candidate must have 3-5 years of experience to work on healthcare regulatory ...
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A global and top 200 Am Law firm seeks an associate to join their Healthcare Team in their Austin office. The ideal candidate must have 3-5 years of experience to work on healthcare regulatory ...
Healthcare Regulatory Associate Attorney
Dallas, TX · On-site
$260K - $390K/yr
Direct Counsel is seeking a Healthcare Regulatory Associate with 3-6 years of healthcare transactional and regulatory experience to join a premier healthcare practice advising healthcare providers ...
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Healthcare Regulatory Associate Attorney
Dallas, TX · On-site
$260K - $390K/yr
Direct Counsel is seeking a Healthcare Regulatory Associate with 3-6 years of healthcare transactional and regulatory experience to join a premier healthcare practice advising healthcare providers ...
The Regulatory Affairs Associate builds and maintains strong relationships with colleagues in Quality and Commercial ensuring optimal compliance from cGMP and Regulatory standpoint. Key Role Specific ...
The Regulatory Affairs Associate builds and maintains strong relationships with colleagues in Quality and Commercial ensuring optimal compliance from cGMP and Regulatory standpoint. Key Role Specific ...
Regulatory Affairs Associate
Houston, TX · On-site
The Regulatory Affairs Associate builds and maintains strong relationships with colleagues in Quality and Commercial ensuring optimal compliance from cGMP and Regulatory standpoint. Key Role Specific ...
Regulatory Affairs Associate
Houston, TX · On-site
The Regulatory Affairs Associate builds and maintains strong relationships with colleagues in Quality and Commercial ensuring optimal compliance from cGMP and Regulatory standpoint. Key Role Specific ...
Regulatory Affairs Associate - Clinical Research
Houston, TX · On-site
$70K - $83K/yr
Regulatory Affairs Associate - Clinical Research Division: Pediatrics Work Arrangement: Onsite only Location: Houston, TX Salary Range: $70,618 - $83,080 FLSA Status: Exempt Work Schedule: Monday ...
Regulatory Affairs Associate - Clinical Research
Houston, TX · On-site
$70K - $83K/yr
Regulatory Affairs Associate - Clinical Research Division: Pediatrics Work Arrangement: Onsite only Location: Houston, TX Salary Range: $70,618 - $83,080 FLSA Status: Exempt Work Schedule: Monday ...
Summary The Regulatory Affairs Associate works to support the Protocol Office and investigators associated with Baylor College of Medicine Department of Pediatrics at The Texas Children's Cancer and ...
Summary The Regulatory Affairs Associate works to support the Protocol Office and investigators associated with Baylor College of Medicine Department of Pediatrics at The Texas Children's Cancer and ...
The Associate Regulatory Affairs Specialist will support regulatory activities related to the medical device Total Product Lifecycle, including product maintenance and global submissions.
The Associate Regulatory Affairs Specialist will support regulatory activities related to the medical device Total Product Lifecycle, including product maintenance and global submissions.
The Associate Regulatory Affairs Specialist will support regulatory activities related to the medical device Total Product Lifecycle, including product maintenance and global submissions.
The Associate Regulatory Affairs Specialist will support regulatory activities related to the medical device Total Product Lifecycle, including product maintenance and global submissions.
The Associate Director, Regulatory Affairs - CMC will be responsible for leading the global regulatory CMC strategy for product development and registration, and for the preparation of CMC dossier in ...
The Associate Director, Regulatory Affairs - CMC will be responsible for leading the global regulatory CMC strategy for product development and registration, and for the preparation of CMC dossier in ...
Position may be filled at Associate or Sr. Associate levels. See specific qualifications below ... Provide project management support to ensure regulatory initiatives and obligations are executed ...
Position may be filled at Associate or Sr. Associate levels. See specific qualifications below ... Provide project management support to ensure regulatory initiatives and obligations are executed ...
Associate Director of Regulatory DM Clinical Research, the largest privately-owned clinical research organization in the Houston area and one of the top fifty in the country, is looking for an ...
Associate Director of Regulatory DM Clinical Research, the largest privately-owned clinical research organization in the Houston area and one of the top fifty in the country, is looking for an ...
Associate Regulatory Affairs Professional to Senior Regulatory Affairs Professional
Houston, TX · On-site
Obtains regulatory and chemical composition from suppliers required for hazard communication, permits, and other regulatory needs. * Prepares data and documents required by government, third party ...
Associate Regulatory Affairs Professional to Senior Regulatory Affairs Professional
Houston, TX · On-site
Obtains regulatory and chemical composition from suppliers required for hazard communication, permits, and other regulatory needs. * Prepares data and documents required by government, third party ...
Associate Regulatory Affairs Professional to Senior Regulatory Affairs Professional
Houston, TX · On-site
Obtains regulatory and chemical composition from suppliers required for hazard communication, permits, and other regulatory needs. * Prepares data and documents required by government, third party ...
Associate Regulatory Affairs Professional to Senior Regulatory Affairs Professional
Houston, TX · On-site
Obtains regulatory and chemical composition from suppliers required for hazard communication, permits, and other regulatory needs. * Prepares data and documents required by government, third party ...
Obtains regulatory and chemical composition from suppliers required for hazard communication, permits, and other regulatory needs. * Prepares data and documents required by government, third party ...
Obtains regulatory and chemical composition from suppliers required for hazard communication, permits, and other regulatory needs. * Prepares data and documents required by government, third party ...
Regulatory Associate information
See Texas salary details
$15.90 - $18.59
12% of jobs
$18.59 - $21.28
6% of jobs
$22.80 is the 25th percentile. Wages below this are outliers.
$21.28 - $23.96
12% of jobs
$23.96 - $26.65
12% of jobs
The median wage is $28.67 / hr.
$26.65 - $29.34
11% of jobs
$29.34 - $32.03
14% of jobs
$34.63 is the 75th percentile. Wages above this are outliers.
$32.03 - $34.71
9% of jobs
$34.71 - $37.40
11% of jobs
$37.40 - $40.09
3% of jobs
$40.09 - $42.78
5% of jobs
$42.78 - $45.46
5% of jobs
$15
$30
$45
How much do regulatory associate jobs pay per hour?
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.
What are the key skills and qualifications needed to thrive as a regulatory associate, and why are they important?
What are some common challenges regulatory associates face when working with cross-functional teams?
What is the difference between Regulatory Associate vs Compliance Specialist?
| Aspect | Regulatory Associate | Compliance Specialist |
|---|---|---|
| Required Credentials | Bachelor's degree in life sciences, regulatory affairs, or related field; certifications like RAC are a plus | Bachelor's degree in law, business, or related; certifications like CCEP may be relevant |
| Work Environment | Pharmaceutical, biotech, or medical device companies; regulatory departments | Corporate compliance departments across various industries, including healthcare and finance |
| Employer & Industry Usage | Used in regulated industries to prepare and submit regulatory documents | Used 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.
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Research Regulatory Associate I
San Antonio, TX • On-site
Full-time
Re-posted 19 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
About Urology San Antonio
Sourced by ZipRecruiter
Industry
Outpatient health care
Company size
201 - 500 Employees
Headquarters location
San Antonio, TX, US
Year founded
1996