Regulatory Affairs Consultant - Process & Compliance (Veeva Quality Document Management SME)

📋 Description

• Document Governance: Serve as a subject matter expert for controlled document management in Veeva
• Regulatory Compliance: Support global GxP compliance activities, identify potential risks
• Inspection Readiness: Prepare for and support regulatory inspections and audits conducted by health
• Training Governance: Manage and support GxP training processes, ensuring role-based curricula
• Quality Management Systems: Support and improve QMS processes, including deviations, corrective and
• Process Optimization: Improve document templates, formatting standards, workflows, and governance

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or a related field.
• At least 8 years of experience in regulatory compliance, quality assurance, regulatory affairs, or
• Demonstrated hands-on experience authoring, formatting, reviewing, approving, and maintaining
• Strong understanding of FDA, EMA, ICH, and global GxP regulations, along with document control
• Proven experience supporting regulatory inspections, audit management, inspection readiness, and
• Experience managing GxP training governance, learning management systems (LMS), role-based training

🎁 Benefits

• Health, vision, and dental insurance.
• Retirement savings plan with employer matching contributions (401(k), where applicable).
• Tuition reimbursement and professional development opportunities.
• Paid vacation, holidays, and sick leave.
• Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA), where applicable.
• Work-life balance initiatives and a flexible remote working environment.