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 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.
Candidate Profile
You'll thrive in this role if you bring:
- 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)
Required Qualifications
- 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
Preferred Qualifications
- 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 and Compensation
- 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
For a complete list of benefits, please visit www.parexel.com/us-benefits.
Parexel offers competitive salaries based on several factors, including the position and level offered, skills, education, training, training, experience, professional achievements, and location.
Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.
If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!
We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.
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