Regulatory Coordinator

Overview

We are seeking a detail-oriented Regulatory Coordinator to support Regulatory, Quality, and Safety functions in a regulated pharmaceutical environment. This role focuses on operational coordination, documentation, and compliance support, requiring strong administrative skills, digital proficiency, and attention to detail.

Key Responsibilities

• Provide operational support to Regulatory, Quality, and Safety teams
• Process vendor contracts, purchase orders, invoices, and payments
• Track expenses against annual budgets
• Support onboarding/offboarding of employees and agency staff
• Coordinate off-site meetings, including in-person FDA meetings
• Track and coordinate regulatory submissions (NDAs, INDs, PADERS, Safety Quarterly, Devices)
• Manage regulatory archives and FDA communications
• Support Quality documentation, logbooks, and archives
• Receive and coordinate complaint samples with QA

Required Skills & Experience

• 2+ years of administrative or operations support experience in a mid-to-large corporate environment
• On-site availability minimum 4 days per week
• Proficiency with Microsoft Outlook, Teams, SharePoint, Excel, and Word
• Experience with Adobe tools (e.g., Adobe Sign)
• Experience with contract management systems (e.g., Icertis)
• Experience with procurement/payment systems (e.g., COUPA)
• Strong organizational, time management, and confidentiality skills

Plusses

• Experience in pharmaceutical or biotech environments
• Familiarity with GxP requirements
• Experience supporting FDA submissions or quality systems
• Veeva document management experience