Top 32 Regulatory affairs Jobs in Spring, Tx

Regulatory Affairs Specialist
Baylor College of Medicine —Houston, TX
- $57,320 - $67,435 a year
- Full-time
- No experience needed
- Mid-level
- High school diploma or GED
4d
Regulatory Affairs Specialist (Food Manufacturing)
Dessert Holdings Inc. —Humble, TX
- Overtime
- Mid-level
- Bachelor's degree
- 1 year
Quick Apply
Manager, Regulatory Affairs - Clinical Research
Baylor College of Medicine —Houston, TX
- $111,118 - $130,000 a year
- Full-time
- Hybrid work
- Office
- Master's degree
- Bachelor's degree
10d
Associate Regulatory Affairs Professional to Senior Regulatory Affairs Professional
Halliburton —Houston, TX
- Full-time
- OSHA
- Customer service
- Mid-level
1d
Director, External Relations & Regulatory Affairs
Standard Lithium —Houston, TX
- Full-time
- Hybrid work
- 11+ years
- Office
- Analysis skills
Regulatory Affairs Specialist
Cordialsa USA —The Woodlands, TX
- Full-time
- Hybrid work
- Spanish
- 5 years
- English
- Dental insurance
- Paid time off
Quick Apply
REGULATORY AFFAIRS CONSULTANT
Suttons Creek Inc —Houston, TX
- 5 years
- Senior level
Research Quality Assurance Specialist
Houston VA Research and Educ —Houston, TX
- 8 hour shift
- Hybrid work
- Computer literacy
- Writing skills
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Medical Science Liaison, Field Medical Affairs (Regional Medical Liaison) (Greater Texas)
Kailera Therapeutics, Inc. —Houston, TX
- $196,000 - $235,000 a year
- Full-time
- Hybrid work
- Medicine
- Mid-level
- Driver's License
- Commuter assistance
- Paid holidays
Quick Apply
Regulatory Consultant
Danos, LLC —Houston, TX
- 7 years
- Pass drug screening
- Analysis skills
Quick Apply
Director / Manager Tariffs and Regulatory Affairs
Kinder Morgan —Houston, TX
- Extended hours
- Background check
- Microsoft Outlook
- 5 years
9d
Medical Liaison - Red / Rr Southwest
Novo Nordisk —Houston, TX
- $170,000 - $245,000 a year
- Doctoral degree
- Mid-level
- Driver's License
- Disability insurance
- Health insurance
8d
HIV Hybrid Medical Science Liaison
EVERSANA —Houston, TX
- $185,000 - $220,000 a year
- Full-time
- Hybrid work
- Bachelor of Science
- Doctor of Philosophy
- Travel
Quick Apply
Analyst - Manager IC - Regulatory (Houston, TX)
Kinder Morgan —Houston, TX
- Full-time
- Microsoft Outlook
- Mid-level
- Office
Manager Market Strategy & Analysis
Calpine Energy Solutions, LLC —Houston, TX
- $91,895 - $135,545 a year
- Email
- 7 years
- Bachelor's degree
- Travel
FDA Compliance Officer
Optima Multivitamins USA —Houston, TX
- $55,943.92 - $67,373.33 a year
- Full-time
- Mid-level
- Bachelor's degree
- In-person
Quick Apply
Regulatory Compliance Engineer
Mobius Renewables —Houston, TX
- Full-time
- Writing skills
- Engineering
- 3 years
Quick Apply
Advertising Compliance Specialist
Corebridge —Houston, TX
- Email
- Hybrid work
- Research
- Mid-level
- Office
- Wellness program
- Health insurance
Sub-Investigator
Johnson County Clintrials LLC —Houston, TX
- Full-time
- 5 years
- HIPAA
- Inpatient
Quick Apply
R&D Cosmetic Laboratory Manager
Bayport Laboratories LLC —Houston, TX
- Full-time
- Bachelor's degree
- Continuous improvement
- Mentoring
- Health insurance
- Dental insurance
Quick Apply

I want to receive the latest job alert for regulatory affairs in spring, tx

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

regulatory affairs jobs near spring, tx

Liaison jobs in Waltham, MA

Liaison jobs in Houston, TX

Market Manager jobs in Houston, TX

Compliance Officer jobs in Houston, TX

R&D Engineer jobs in Houston, TX

Director Of Regulatory Affairs jobs in Houston, TX

Regulatory Affairs Specialist jobs in Houston, TX

Quality Assurance Specialist jobs in Houston, TX

Administrator jobs in Houston, TX

School Based Behavior Health Liaison jobs in Tennessee

Community Liaison jobs in Atlanta, GA

Clinical Liaison jobs in Tampa, FL

Family School Liaison jobs in Kansas City, MO

Foster Youth Education Liaison jobs in Los Angeles, CA

Clinical Liaison jobs in Houston, TX

Clinical Rehab Liaison jobs in Texas

Medical Scientific Liaison jobs in Maryland

Medical Science Liaison jobs in San Diego, CA

Medical Science Liaison jobs in Chicago, IL

Clinical Liaison jobs in Boston, MA

Regulatory Affairs Specialist

Baylor College of Medicine -
Houston, TX

Apply Now

Job Details

Full-time
$57,320 - $67,435 a year
4 days ago

Qualifications

High school diploma or GED

Full Job Description

Summary

The Regulatory Affairs Specialist works to support the investigators and clinical research operations associated with The Texas Children's Cancer and Hematology Centers (TXCH). This position supports all aspects of regulatory compliance for a specified portfolio of over 80 studies. This support includes, but is not limited to, reviewing protocols and protocol related documents, submitting protocols to regulatory agencies and review committees and ensuring successful navigation of approval processes for clinical research. This role covers a significant portion of our Phase 1 protocols as well as protocols from our most prolific consortia (PBTC and PNOC) which require specific tasks and expertise.

A Specialist will be assigned low to mid regulatory complexity projects including large consortium protocols using a central IRB where there are less editing needs. The Specialist will handle assigned protocols independently including but not limited to sponsor correspondence, monitoring, review board submissions (initial, amendments, renewals). This role will centrally process safety reports, consortium correspondence, broadcast reviews and distribution, team mailbox tasks, protocol approvals. The Specialist will work with their assigned PIs to maintain compliance for their assigned protocols and will cover for their peers as needed. For more complex projects, they are needing direction.

Job Duties

Follow SOPs, coordinates regulatory correspondence across internal stakeholders and external institutions. Prepares protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval for the conduct of clinical research projects at the TXCH.
Maintain and expands understanding of federal regulations, ICH GCP guidelines and internal SOPs by producing work in compliance with those regulations, guidelines and SOPs.
Acts as a liaison between institutional review committees, regulatory agencies and the investigators to ensure that protocols obtain applicable approvals, that protocol amendments are submitted appropriately and that annual renewals are obtained.
At the guidance of the Director, works closely with the study team, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
Enables communication with IRB and other applicable agencies related to Adverse Events and Unanticipated Problems reporting.
Following SOPs, ensures distribution of appropriate information between investigators, regulatory agencies and staff involved in implementation of research projects.
Maintains regulatory database and systems as applicable (e.g. CTMS, OneDrive, Advarra eReg). Maintains electronic and paper study files in accordance with local SOPs, sponsor and general industry standards ensuring documentation is complete, up to date, and audit ready.
Keep the study team and supervisor informed of protocol related issues.
Practices a high level of integrity and honesty in maintaining confidentiality.
Works proactively and collaboratively with other team members to streamline work and achieve mutual goals.
Attends all required meetings, contributes pertinent protocol information and uses information presented to develop an understanding of the hematology/oncology landscape, in order to more accurately assist in the preparation of submissions.
Plans and pursues activities to promote self development related to hematology/oncology and regulatory issues.
Performs other job related duties as assigned.

Minimum Qualifications

High School diploma or GED.
Four years of relevant experience.

Preferred Qualifications

Bachelor’s degree. No experience required with Bachelor’s degree.
Two or more years of experience specifically in regulatory affairs and/or clinical research at academic medical center or hospital with knowledge of clinical research practices and regulations. Experience in regulatory affairs for clinical research preferred.
Certification in Clinical Research, SOCRA or other preferred.
Knowledge and understanding of clinical research compliance, including OHRP, FDA and other federal regulations and requirements regarding human subjects research, including but not limited to GCPs and related ICH guidelines, informed consent, adverse event reporting and monitoring, and other human subjects research protection requirements.
Ability to serve as a resource to clinical investigators and staff.
Ability to manage shifting priorities in short time frames.
Should have excellent oral and written communication skills
Knowledge of medical/scientific terminology preferred
Excellent organization skills; ability to multi-task
Strong computer skills including Microsoft Office Suite
High sense of professional behavior and conduct and an ability to communicate with various levels of faculty and staff within Baylor College of Medicine and outside organizations
Knowledge of clinical research and/or regulatory processes and the applicable federal regulations and ICH GCP guidelines preferred

Work Authorization Requirement:

This position is not eligible for visa sponsorship. Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

Apply Now

Refine Your Search

regulatory affairs jobs in spring, tx

Regulatory Affairs Specialist

Regulatory Affairs Specialist (Food Manufacturing)

Manager, Regulatory Affairs - Clinical Research

Associate Regulatory Affairs Professional to Senior Regulatory Affairs Professional

Director, External Relations & Regulatory Affairs

Regulatory Affairs Specialist

REGULATORY AFFAIRS CONSULTANT

Research Quality Assurance Specialist

Medical Science Liaison, Field Medical Affairs (Regional Medical Liaison) (Greater Texas)

Regulatory Consultant

Director / Manager Tariffs and Regulatory Affairs

Medical Liaison - Red / Rr Southwest

HIV Hybrid Medical Science Liaison

Analyst - Manager IC - Regulatory (Houston, TX)

Manager Market Strategy & Analysis

FDA Compliance Officer

Regulatory Compliance Engineer

Advertising Compliance Specialist

Sub-Investigator

R&D Cosmetic Laboratory Manager

I want to receive the latest job alert for regulatory affairs in spring, tx

Related Searches

Explore jobs in more locations

Summary

Job Duties

Minimum Qualifications

Preferred Qualifications

Job Seeker Tools

Employer Tools

Browse

Stay Connected