Senior Regulatory Manager, Clinical Trials Lead

Pharmaron; Baltimore (MD); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

401(k) Retirement Plan

Generous PTO & Holidays

HSA contributions

Career development

Job summary

Pharmaron seeks an onsite Regulatory Manager in Baltimore, MD to lead regulatory operations for Phase I–IV studies. You will manage IRB submissions, TMF documentation, and trial regulatory files in a dynamic CRO setting.

You will mentor a regulatory team, ensure inspection readiness, and coordinate with Sponsors, Clinical Operations, and Quality to maintain compliance and program progress.

Qualifications

• Bachelor's degree or equivalent combination of education, training, and experience.
• 5-10 years of clinical research regulatory experience.
• Experience managing IRB submissions and approvals.
• Experience with essential documents for clinical trials.

Responsibilities

• Lead regulatory activities across the full trial lifecycle, including IRB submissions and amendments.
• Maintain regulatory binders and electronic TMF to ensure inspection-readiness.
• Support study startup regulatory documentation and sponsor interactions.
• Mentor Regulatory team members and drive performance.
• Serve as regulatory liaison with Sponsors, IRBs, Clinical Ops and QA.

Skills

Regulatory submissions

IRB submissions

TMF management

Team leadership

FDA regulations

Education

Bachelor's degree in life sciences

Tools

Veeva Vault TMF

Florence eTMF

Job description

Pharmaron seeks an onsite Regulatory Manager in Baltimore, MD to lead regulatory operations for Phase I–IV studies. You will manage IRB submissions, TMF documentation, and trial regulatory files in a dynamic CRO setting.

You will mentor a regulatory team, ensure inspection readiness, and coordinate with Sponsors, Clinical Operations, and Quality to maintain compliance and program progress.