Manager, Regulatory Operations (Remote)

START Research; San Antonio (TX); Remote; USD 110,000 - 135,000; Full time

Benefits offered by this job

401(k) employer match

Annual performance bonus

Paid time off and holidays

Medical, dental, vision coverage

Life and disability insurance

Employee Assistance Program (EAP)

FSA/HSA options

Job summary

START Research seeks a Manager, Regulatory Operations (Remote) to lead regulatory activities for START USA. You will oversee submissions, ISFs, and team performance, ensuring compliance with IRB, IBC, and FDA requirements while driving process improvements.

The role emphasizes leadership, collaboration, and standardization across sites, with a base salary of $110,000–$135,000 per year and comprehensive benefits. Remote work is supported, with travel up to 10% as needed.

Qualifications

• Bachelor’s degree or equivalent experience.
• 5+ years in regulatory research with oversight of submissions and maintenance.
• MS Office and regulatory data tracking systems (Jira, Veeva, Advarra E-Reg).
• Excellent leadership, organizational, and communication skills with attention to detail.
• Advanced knowledge of IRB, FDA, and IBC requirements; audit/inspection readiness.

Responsibilities

• Provide direct people leadership for the assigned team.
• Lead goals with Regulatory Operations Leadership and QA; ensure timely regulatory deliverables.
• Oversee submissions to ensure accuracy, timely completion, and workload balance.
• Establish and improve SOPs, templates, and training for standardization and scalability.
• Maintain IRB relationships with IRBs and Sponsors/CROs.
• Supervise daily Regulatory Operations activities to meet deadlines.
• Monitor metrics and drive corrective actions with QA and stakeholders.
• Escalate complex regulatory issues and coordinate with IRBs, IBCs, FDA, and Sponsors/CROs.
• Attend SOP Committee meetings; provide regulatory input and update SOPs.
• Collaborate with other START departments and Regional Director to meet deadlines and manage systems.
• Prepare and submit new studies, draft ICs, coordinate with IRB and Sponsor; track in FileMaker.
• Prepare and submit study documents to IRB and IBC; manage status reports.
• Submit Expanded Access studies to FDA; respond to inquiries.
• Maintain ISF for assigned studies and manage close-out visits.

Skills

Leadership

Communication

Regulatory submissions

IRB/FDA knowledge

Audit readiness

Education

Bachelor’s degree or equivalent experience

Tools

Microsoft Office

Jira

Veeva

Advarra E-Reg

Job description

The START Center for Cancer Research (“START”) is the world’s largestearly phasesite network, fully dedicated tooncologyclinical research.Throughout ourhistory, START has provided hope to cancer patients inglobalcommunity practices by offering\"Hope Through Access”tocutting edgetrials throughout the UnitedStatesand Europe.

We are seeking a Manager, Regulatory Operations (Remote). This role performsoperational leadership for theRegulatory Operations function across START USA.This role leads and develops a team that includesSpecialists), and Assistants to ensuretimely,accurate, and compliant regulatory submissions and maintenance of inspection-ready Investigator Site Files (ISFs). The Manager, Regulatory Operationsis accountable for team performance, process standardization, metrics, training and onboarding, and continuous improvement of systems and workflows supporting IRB, IBC, and FDA interactions, in alignment with applicable regulations and guidelines (e.g., GCP, FDA BIMO, 21 CFR Part 11).

The annual base salary for this role is $110,000 - $135,000. However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience.

Work Schedule:

Monday-Friday 8:00am-5:00pm

Location:

Remote

Essential Responsibilities:

• Provide direct people leadership for assigned team.
• Partner with the Regulatory Operations Leadership and Quality Assurance to set departmental goals and ensure timely execution of regulatory deliverables that support study startup, conduct, maintenance and close out.
• Oversee day to day regulatory operations to ensure submissions are accurate, complete and on time; balance workloads and assign / re-distribute studies based on capacity and complexity.
• Establish, maintain, and continuously improve SOPs, work instructions, templates, and training materials to drive standardization, quality, and scalability across sites.
• Maintain relationships with Institutional Review Board(s) (IRB) used and Sponsors/CROs.
• Supervise day-to-day activities of the Regulatory Operations staff to ensure that submissions are accurate, and deadlines are met.
• Monitor key metrics (e.g., turnaround times, aging, quality findings) and drive corrective actions and process improvements in partnership with Quality Assurance and cross-functional stakeholders.
• Serve as an escalation point for complex regulatory issues and facilitate timely resolution with IRBs, IBCs, FDA, Sponsors/CROs, and other departments.
• Attend SOP Committee Meetings quarterly, provide regulatory and data input, and revise any SOPs as needed per the meetings.
• Collaborate with other START departments, including Site Clinical departments and Shared Services departments, and Regional Director to provide support and leadership to effectively meet deadlines, prepare for audits, manage various electronic systems and START templates in use at START (i.e., FileMaker, CITI portal, study portals, e-signature platforms, etc.), and special projects as needed.
• Prepare and submit new studies, including drafting the informed consent (IC), to the IRB (local and hospital) as assigned. Serve as the main point of contact with the Sponsor/CRO in negotiating the IC for IRB submission. Serve as the main point of contact with the IRB(s) for the studies. Enter submission dates in FileMaker database, note pending information, and generate status reports as required. Respond to inquiries and follow up on pending items.
• Prepare and submit study documents to the IRB (local and hospital) for assigned studies. This includes, but is not limited to, revised protocols, revised investigator’s brochures, protocol clarification letters/memos, revised ICs, new ICs, continuing review reports, closure reports, serious adverse events, IND safety reports, unanticipated problems, protocol deviations, and waivers. Serve as the main point of contact with the IRB(s) for the studies. Enter submission dates in FileMaker database, note pending information, and generate status reports as required. Respond to inquiries and follow up on pending items.
• Prepare and submit study documents to the Institutional Biosafety Committee (IBC) as assigned. Serve as the main point of contact with the IBC for the studies. Enter submission dates in FileMaker database, note pending information, and generate status reports as required. Respond to inquiries and follow up, as required, on pending items.
• Prepare and submit Expanded Access Studies to the US Food and Drug Administration (FDA) as assigned. Serve as the main point of contact with the FDA and IRB for the studies. Enter submission dates in FileMaker database, note pending information, and generate status reports as required. Respond to inquiries and follow up, as required, on pending items.
• Maintain the ISF (paper and/or electronic) for assigned studies. This includes, but is not limited to, IRB submissions, IRB approvals, study documents, and study correspondence.
• Prepare and manage Close-Out Visits for assigned studies.

Education & Experience:

• Bachelor’s degree or equivalent experience in lieu of degree.
• 5+ years of progressive experience in a regulatory research setting, including oversight of new study submissions and ongoing maintenance and management experience.
• Proficiency with Microsoft Office and Regulatory Data Tracking / Document Management Systems (e.g., Jira, Veeva, Advarra E-Reg).
• Excellent leadership, organizational, and communication skills with a high level of attention to detail.
• Advanced working knowledge of IRB, FDA, and IBC requirements with experience supporting audit / inspection readiness.

Physical & Travel Requirements

• Travel required up to 10% of the time
• Sitting for extended periods of time.
• Typing and computer use for extended periods of time.

Best-in-Class Benefits and Perks

We value the time, talent, and dedication our employees bring to START. Our commitment to yourwell-beingand growth is reflected in a competitive compensation package—based on experience—along with comprehensive benefits designed to support you both personally and professionally:

• 401(k) retirement savings plan with employer match
• Eligibility for an annual performance bonus, based on role and company results
• Generous paid time off and paid holidays
• Comprehensive medical, dental, and vision coverageand optional insuranceoptions
• Companyp‑aid life and disability insurance for added financial protection
• Employee Assistance Program (EAP) providing confidential, no‑cost support for you and your family from day one
• Flexible FSA and HSA plans to support your financial wellness
• Commitment to a supportive environment that values balance, wellbeing, and flexibility
• We’recommitted to fostering a collaborative, creative workplace where every team member is encouraged to contribute. At START,you’lljoin a team that values continuous learning, professional growth, shared ideas, and a culture built on inclusivity and innovation.

More About START

START clinical trial sites have conducted more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA. STARTrepresentsthe world’s largest roster of early-phase principal investigators across its Network of clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world via our mission of “Hope Through Access”.As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda –one ofthe most effective cancerdrugsin medical history.

Learn more at STARTresearch.com.

Ready to be part of a team changing the future of cancer treatment?

Join us in our mission to conquer cancer, one clinical trial at a time. Yourexpertiseand dedication can help us bring hope and healing to patients worldwide.

We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminateon the basis ofrace, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.