Regulatory Affairs Consultant – Process & Compliance, Veeva Quality Document Management SME

Job Description:

• Serve as a subject matter expert for controlled document management processes within Veeva Quality
• Ensure compliant document governance and inspection readiness across Regulatory and Quality operations
• Author, format, review, approve, and manage controlled procedures and quality documents throughout their lifecycle
• Support and lead regulatory compliance activities across global GxP operations
• Identify, assess, and mitigate compliance risks with cross-functional teams
• Drive inspection readiness and support FDA, EMA, MHRA, and other global health authority inspections
• Develop remediation plans for audit findings, inspection observations, and internal compliance gaps
• Support and oversee GxP training governance, including curricula, assignments, completion tracking, documentation, effectiveness, and personnel qualification requirements
• Monitor training compliance metrics and remediate overdue or non-compliant training records
• Manage and continuously improve QMS processes including deviations, CAPAs, change controls, SOP management, training compliance, risk assessments, and document control
• Monitor evolving regulatory requirements and support compliance strategies
• Improve document templates, formatting standards, workflows, and governance practices within Veeva Quality
• Guide teams on procedural writing, document management, training governance, and compliant Veeva system use
• Use metrics and trend analysis to identify compliance risks and drive operational excellence
• Collaborate with Regulatory Affairs, Quality, CMC, Clinical Operations, Pharmacovigilance, and Medical Writing teams

Requirements:

• Previous experience in controlled document management, procedural governance, and GxP training governance
• Experience working in clinical research, biotechnology, pharmaceutical, or other regulated environments
• Previous experience working with Veeva Vault or similar eDMS, learning management systems (LMS), and Quality Management Systems (QMS)
• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or a related field
• 8+ years of experience in regulatory compliance, quality assurance, regulatory affairs, or related GxP functions within biotechnology or pharmaceutical industries
• Strong knowledge of FDA, EMA, ICH, and global GxP regulations
• Experience supporting regulatory inspections, audit management, and inspection readiness activities
• Strong understanding of document control processes, procedural governance, and GxP documentation standards
• Hands-on experience authoring, formatting, reviewing, approving, and managing controlled procedures and quality documents within Veeva Vault or similar eDMS
• Experience managing document workflows, approvals, periodic reviews, and document lifecycle management activities
• Experience supporting GxP training governance processes, training compliance oversight, and learning management systems (LMS) within regulated pharmaceutical or biotechnology environments
• Understanding of role-based training requirements, procedural training impact assessments, and inspection expectations related to personnel qualification and training documentation
• Working knowledge of Quality Management Systems and compliance governance processes
• Strong analytical, communication, and stakeholder management skills
• Ability to manage multiple priorities in a fast-paced and evolving environment
• Preferred: experience within biologics, vaccines, mRNA, or advanced therapeutics environments
• Preferred: experience supporting global compliance initiatives across multiple regions or functional areas
• Preferred: strong risk management and problem-solving capabilities
• Preferred: demonstrated ability to influence cross-functional teams without direct authority
• Preferred: experience driving process improvement and operational excellence initiatives
• Preferred: familiarity with digital quality and compliance tools, including Veeva Vault and LMS

Benefits:

• Health, Vision & Dental Insurance
• Tuition Reimbursement
• Vacation/Holiday/Sick Time
• Flexible Spending & Health Savings Accounts
• Work/Life Balance
• 401(k) with Company match
• Pet Insurance
• Some roles may also be eligible for additional incentives, bonuses, or other compensation programs