Remote Regulatory Affairs Consultant - Process & Compliance

Parexel; United States; Remote; USD 130,000 - 190,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Regulatory Affairs Consultant, Process & Compliance (Regulatory Document Governance) for a remote role on a major client program. You will govern controlled documents in Veeva Quality, drive inspection readiness, and support QMS processes across Regulatory and Quality teams.

You will collaborate with Regulatory Affairs, Quality, and Clinical Operations to ensure compliant documentation, training governance, and continuous improvement in a fast-paced, global environment.

Qualifications

• 8+ years of experience in regulatory compliance, quality assurance, regulatory affairs, or related GxP functions within biotech/pharma industries.
• Experience supporting regulatory inspections, audit management, and inspection readiness.
• Strong knowledge of FDA, EMA, ICH, and global GxP regulations.
• Hands-on authoring, formatting, reviewing, approving, and managing controlled procedures and quality documents in Veeva Vault or similar eDMS.
• Understanding of document control processes and procedural governance.

Responsibilities

• Serve as SME for controlled document management within Veeva Quality; ensure compliant governance and inspection readiness across Regulatory and Quality operations.
• Author, format, review, approve, and manage controlled procedures and quality documents per GxP requirements; manage lifecycle from creation to obsolescence.
• Support regulatory compliance activities across global GxP operations; identify, assess, and mitigate compliance risks.
• Drive inspection readiness initiatives and support regulatory inspections by FDA, EMA, MHRA, and others; address audit findings and gaps.
• Oversee training governance, ensuring LMS-based curricula align with roles, updates, and training documentation for inspections.

Skills

GxP compliance

Cross-functional collaboration

Attention to detail

Communication

Regulatory documents governance

Education

Bachelor's degree in Life Sciences or related field

Tools

Veeva Vault

LMS

Job description

Parexel is seeking a Regulatory Affairs Consultant, Process & Compliance (Regulatory Document Governance) for a remote role on a major client program. You will govern controlled documents in Veeva Quality, drive inspection readiness, and support QMS processes across Regulatory and Quality teams.

You will collaborate with Regulatory Affairs, Quality, and Clinical Operations to ensure compliant documentation, training governance, and continuous improvement in a fast-paced, global environment.