Top 10 Regulatory affairs manager Jobs in Houston, Tx

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
12d
Manager, Compliance and Regulatory Affairs
Suvida Healthcare —Houston, TX
- Full-time
- Spanish
- 5 years
- HIPAA
- Paid parental leave
- Paid holidays
Quick Apply
5d
Director / Manager Tariffs and Regulatory Affairs
Kinder Morgan —Houston, TX
- Extended hours
- Background check
- Microsoft Outlook
- 5 years
10d
Director, External Relations & Regulatory Affairs
Standard Lithium —Houston, TX
- Full-time
- Hybrid work
- 11+ years
- Office
- Analysis skills
Ethics and Compliance Analyst
Citgo Petroleum Corporation —Houston, TX
- Mid-level
- Office
- Analysis skills
- Health savings account
- Paid holidays
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
Channel Infrastructure Regulatory Development Project Manager 2
Port Houston —Houston, TX
- Full-time
- 11+ years
- Office
- Master's degree
Project Lead - RUA92307
IQVIA —Houston, TX
- $200,000 - $225,000 a year
- Full-time
- Nursing
- Driver's License
- Travel
1d

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Baylor College of Medicine —Houston, TX
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Manager, Regulatory Affairs - Clinical Research

Baylor College of Medicine -
Houston, TX

Apply Now

Job Details

Full-time
$111,118 - $130,000 a year
12 days ago

Qualifications

Staff supervision
Team supervision
Bachelor's degree
Managing clinical research teams

Full Job Description

Summary

Manages and oversees regulatory activities supporting clinical research studies across the Center for Research Advancement (CRA). Provides leadership and direction to regulatory staff, ensuring timely and compliant submission of regulatory documents to institutional, federal, and sponsor entities. Serves as a subject matter expert, interpreting complex regulatory requirements and advising investigators and research teams. Operates with a high degree of autonomy and professional judgment to ensure regulatory compliance, audit readiness, and successful study execution across a diverse clinical portfolio. Supports CRA Regulatory operations across a large and complex clinical research portfolio. Works in close coordination with Clinical Trial Finance, QA/QC, and Research Administration to ensure alignment between regulatory compliance, study activation, and downstream financial processes. Partners with the Protocol Development/IND team as needed to ensure appropriate delineation of responsibilities.

Position is a hybrid role typically working two days a week in office after initial training and onboarding is completed. Office hours are 8-5pm (+/-1hr) to align with clinical operations.

Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.

Job Duties

Regulatory Oversight and Study Lifecycle Management (25%)

Manages regulatory activities across the full clinical trial lifecycle, including study start-up, maintenance, amendments, and close-out.
Oversees preparation, review, and submission of IRB and sponsor documentation, including amendments, continuing reviews, and safety reporting. Ensures all studies meet regulatory requirements and internal timelines, supporting a portfolio of complex, multi-site clinical trials.

Staff Supervision, Leadership, and Work Allocation (20%)

Directly supervises Regulatory Affairs Associates and Senior Associates, including assigning and prioritizing workload, monitoring performance, and ensuring equitable distribution of study portfolios.
Provides day-to-day leadership, coaching, and mentorship to staff operating with varying levels of autonomy.
Supports hiring, onboarding, and professional development while maintaining appropriate span of control for a high-complexity regulatory environment.

Regulatory Compliance and Risk Management (15%)

Maintains institutional compliance with applicable federal regulations (FDA, ICH-GCP), sponsor requirements, and BCM/TCH policies.
Proactively identifies compliance risks, escalates issues as appropriate, and implements corrective actions.
Ensures audit readiness and supports internal and external audits/inspections.

Protocol Support and Regulatory Coordination (10%)

Provides regulatory support for clinical protocols by coordinating submissions, reviewing regulatory content for completeness and compliance, and ensuring alignment with institutional requirements.
Collaborates with protocol development and cross-functional teams to support study activation and amendment processes.

Regulatory Strategy, Interpretation, and Stakeholder Guidance (10%)

Serves as a regulatory subject matter expert, interpreting evolving regulations and providing strategic guidance to investigators, study teams, and leadership.
Interfaces with institutional partners and sponsors as needed to facilitate study approvals and ongoing compliance.

SOP Development, Training, and Continuous Improvement (10%)

Develops, updates, and enforces standard operating procedures (SOPs) to standardize regulatory processes.
Trains regulatory and cross-functional staff on SOPs, regulatory requirements, and best practices.
Identifies process gaps and drives continuous improvement initiatives.

Systems, Reporting, and Documentation Management (10%)

Oversees maintenance of regulatory systems, databases, and document repositories.
Ensures accurate and timely updates to electronic regulatory records and supports reporting and tracking of key regulatory metrics and submission timelines.
Performs other job-related duties as assigned.

Minimum Qualifications

Bachelor's degree.
Four years of relevant experience.

Department Specific Criteria

At least four years of regulatory or clinical research experience
Demonstrated experience managing regulatory submissions, multi-study/site portfolios, and staff supervision

Preferred Qualifications

Master's degree
Certification as a Clinical Research Professional (CRP) or Clinical Research Coordinator (CRC) (SoCRA or ACRP)

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 manager jobs in houston, tx

Manager, Regulatory Affairs - Clinical Research

Manager, Compliance and Regulatory Affairs

Director / Manager Tariffs and Regulatory Affairs

Director, External Relations & Regulatory Affairs

Ethics and Compliance Analyst

Analyst - Manager IC - Regulatory (Houston, TX)

Manager Market Strategy & Analysis

Channel Infrastructure Regulatory Development Project Manager 2

Project Lead - RUA92307

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