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Regulatory Affairs Consultant – Process & Compliance, Veeva Quality Document Management SME
Posted last week
About the role
- Regulatory Affairs Consultant governing Veeva quality documents, GxP training, and QMS compliance. Supporting Parexel’s clinical research and regulatory solutions for biopharmaceutical clients.
Responsibilities
- 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
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Experience level
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