Regulatory Manager

Pharmaron • Baltimore, MD

1d • $80,000 - $120,000 • Onsite

About The Position

Pharmaron Clinical Pharmacology Center (CPC) is seeking an experienced Regulatory Manager or Senior Regulatory Manager to lead critical regulatory operations supporting Phase I through Phase IV clinical research studies. This is an exciting onsite opportunity for a regulatory professional who thrives in a fast-paced CRO environment and has deep expertise in IRB submissions, clinical trial regulatory documentation, Trial Master Files (TMF), and team leadership. As the Regulatory Manager, you will serve as the regulatory subject matter expert and oversee regulatory activities from study startup through closeout. In this highly visible role, you will ensure regulatory compliance throughout the clinical trial lifecycle while mentoring and developing a team of regulatory professionals.

Requirements

• Bachelor's degree or equivalent combination of education, training, and experience.
• 5-10 years of clinical research regulatory experience.
• 5-10 years of hands-on experience managing IRB submissions and approvals.
• 5-10 years of experience managing essential documents for clinical trials.
• Strong working knowledge of: ICH-GCP Guidelines, FDA regulations, 21 CFR Part 50 (Protection of Human Subjects), 21 CFR Part 56 (Institutional Review Boards)
• Experience with electronic Trial Master File (eTMF) systems, including: Veeva Vault TMF and/or Florence eTMF
• Excellent written and verbal communication skills.
• Strong organizational, problem-solving, and project management abilities.

Responsibilities

• Lead all regulatory activities throughout the clinical trial lifecycle, including IRB submissions, protocol amendments, informed consent updates, safety reporting, and study closeout submissions.
• Manage and maintain regulatory binders and electronic Trial Master Files (eTMF), ensuring essential documents are complete, compliant, and inspection-ready.
• Oversee study startup regulatory documentation and support sponsor, audit, and inspection readiness activities.
• Lead, mentor, and develop Regulatory team members while driving departmental performance, compliance, and continuous improvement.
• Serve as the primary regulatory liaison with Sponsors, IRBs, Clinical Operations, and Quality teams to support successful study execution and regulatory compliance.

Benefits

• Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
• 401(k) Retirement Plan with generous employer matching
• Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
• Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
• Employee Assistance Program (EAP), mental health resources, and wellness programs
• Family-friendly benefits, including fertility support and maternity resources
• Professional development and career growth opportunities within a leading global CRO/CDMO

What This Job Offers

• Job Type: Full-time
• Career Level: Senior