Regulatory Affairs Consultant – Process & Compliance, Veeva Quality Document Management SME

🔥 1 minute ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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