Regulatory Manager

Pharmaron • Baltimore, MD

2d • 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.

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
• Education Level: Associate degree