Regulatory Affairs Consultant - Process & Compliance (Veeva Quality Document Man

When our values align, there's no limit to what we can achieve.

At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart ®.

About the Role

We are seeking a Regulatory Affairs Consultant, Process & Compliance (Regulatory Document Governance) to join our team in a remote capacity on a large, dedicated client program. In this role, you will support regulatory compliance and quality operations that advance new treatments for patients. You will serve as a subject matter expert for controlled document management in Veeva Quality and help keep the document and training lifecycle compliant, efficient, and inspection-ready across the Regulatory function.

You will collaborate with cross-functional teams, you'll support and enhance Quality Management System processes while applying industry best practices to drive compliance and quality outcomes. Your work will help protect the integrity of the clinical research and therapies delivered to patients. Working in a dynamic, growth-focused environment that encourages continuous learning and collaboration, you'll have the opportunity to expand your expertise and build a rewarding career across clinical research and regulatory affairs.

Key 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 proce