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

Note: The job is a remote job and is open to candidates in USA. Parexel is hiring a Regulatory Affairs Consultant to support regulatory compliance and quality operations on a dedicated client program. The role focuses on controlled document management in Veeva Quality, GxP training governance, QMS processes, and inspection readiness across the Regulatory function.

Responsibilities

• Serve as a subject matter expert for controlled document management processes within Veeva Quality, ensuring compliant document governance and inspection readiness across Regulatory and Quality operations
• Author, format, review, approve, and manage controlled procedures and quality documents in accordance with GxP requirements and internal document standards, driving the full lifecycle including creation, revision, periodic review, approval workflows, archival, and obsolescence management
• Support and lead regulatory compliance activities across global GxP operations, partnering with cross-functional teams to identify, assess, and mitigate compliance risks
• Drive inspection readiness initiatives and support regulatory inspections conducted by agencies including FDA, EMA, MHRA, and other global health authorities, including remediation plans for audit findings, inspection observations, and internal compliance gaps
• Support and oversee GxP training governance processes, maintaining training curricula aligned with role-based responsibilities, procedural updates, and quality system requirements, and ensuring timely assignment, completion, tracking, and documentation of required training in learning management systems (LMS), including support for inspection readiness of training documentation, training effectiveness, and personnel qualification requirements
• Monitor training compliance metrics and support escalation and remediation of overdue or non-compliant training records, assessing training impacts of new or revised procedures and process changes
• Manage and continuously improve Quality Management System (QMS) processes for the Regulatory function, including deviations, CAPAs, change controls, SOP management, training compliance, risk assessments, and document control
• Ensure controlled documents remain clear, compliant, current, and aligned with evolving regulatory expectations and business processes, and monitor evolving regulatory requirements to support implementation of compliance strategies
• Support continuous improvement of document templates, formatting standards, workflows, and governance practices within Veeva Quality, including harmonization and simplification of quality processes
• Provide guidance and support to teams on procedural writing standards, document management best practices, training governance standards, and compliant use of Veeva systems
• Utilize metrics and trend analysis to identify compliance risks and drive continuous improvement and operational excellence initiatives that strengthen quality culture and process efficiency
• Collaborate closely with Regulatory Affairs, Quality, CMC, Clinical Operations, Pharmacovigilance, and Medical Writing teams to provide compliance guidance for operational activities, process changes, and strategic initiatives, contributing to a culture of quality and accountability

Skills

• Previous experience in controlled document management, procedural governance, and GxP training governance
• Experience working in clinical research, biotechnology, pharmaceutical, or other regulated environments
• The ability to collaborate across teams, influence without direct authority, and communicate clearly
• A patient-focused mindset, a strong sense of ownership and accountability, and strong attention to detail
• A commitment to quality, integrity, and continuous improvement, with the agility to thrive in fast-changing 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, with 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
• Experience within biologics, vaccines, mRNA, or advanced therapeutics environments
• Experience supporting global compliance initiatives across multiple regions or functional areas
• Strong risk management and problem-solving capabilities
• Demonstrated ability to influence cross-functional teams without direct authority
• Experience driving process improvement and operational excellence initiatives
• 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
• Remote work

Company Overview

Company H1B Sponsorship