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

Job description

**This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Regulatory Affairs Consultant - Process & Compliance (Veeva Quality Document Management SME) based in United States.** Join a global clinical research environment where regulatory compliance and quality excellence contribute to the development of life-changing therapies. As a Regulatory Affairs Consultant, you will serve as a subject matter expert in controlled document management, with a focus on Veeva Quality and GxP compliance. You will play a key role in maintaining accurate, compliant, and inspection-ready documentation across regulatory and quality operations. Working closely with cross-functional teams, you will strengthen document governance, training compliance, and Quality Management System (QMS) processes. You will also support regulatory inspections, identify compliance risks, and drive continuous improvement initiatives. This fully remote opportunity offers an environment focused on collaboration, professional growth, and operational excellence within the pharmaceutical and biotechnology industries. ### Accountabilities - **Document Governance:** Serve as a subject matter expert for controlled document management in Veeva Quality or similar electronic document management systems (eDMS), overseeing document creation, formatting, review, approval, revision, periodic review, archival, and obsolescence. - **Regulatory Compliance:** Support global GxP compliance activities, identify potential risks, implement mitigation strategies, and ensure documentation remains aligned with applicable regulatory requirements and internal quality standards. - **Inspection Readiness:** Prepare for and support regulatory inspections and audits conducted by health authorities, including the FDA, EMA, and MHRA. Contribute to remediation plans addressing audit findings, inspection observations, and compliance gaps. - **Training Governance:** Manage and support GxP training processes, ensuring role-based curricula reflect procedural updates and quality system requirements. Monitor training assignments, completion rates, overdue records, training effectiveness, and personnel qualification documentation. - **Quality Management Systems:** Support and improve QMS processes, including deviations, corrective and preventive actions (CAPAs), change controls, risk assessments, standard operating procedures (SOPs), document control, and training compliance. - **Process Optimization:** Improve document templates, formatting standards, workflows, and governance practices while promoting harmonized, efficient, and compliant processes across regulatory and quality functions. - **Stakeholder Collaboration:** Partner with Regulatory Affairs, Quality, Chemistry, Manufacturing and Controls (CMC), Clinical Operations, Pharmacovigilance, and Medical Writing teams to provide guidance on compliance requirements, procedural standards, and system best practices. - **Performance Monitoring:** Analyze compliance metrics and trends, identify recurring issues, recommend corrective actions, and contribute to operational excellence and continuous improvement initiatives. - **Guidance and Support:** Advise teams on procedural writing, controlled document management, training governance, and the compliant use of Veeva Quality and related digital quality systems. ## Requirements - **Education:** Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or a related field. - **Professional Experience:** At least 8 years of experience in regulatory compliance, quality assurance, regulatory affairs, or related GxP functions within the pharmaceutical or biotechnology industries. - **Document Management Expertise:** Demonstrated hands-on experience authoring, formatting, reviewing, approving, and maintaining controlled procedures and quality documents using Veeva Vault or a comparable electronic document management system. - **Regulatory Knowledge:** Strong understanding of FDA, EMA, ICH, and global GxP regulations, along with document control requirements, procedural governance, and regulated documentation standards. - **Inspection and Audit Experience:** Proven experience supporting regulatory inspections, audit management, inspection readiness, and the resolution of compliance findings. - **Training Compliance:** Experience managing GxP training governance, learning management systems (LMS), role-based training requirements, procedural impact assessments, and training documentation for inspections. - **Quality Systems Knowledge:** Working knowledge of QMS processes, including CAPAs, deviations, change controls, risk assessments, SOP management, and compliance monitoring. - **Technical Skills:** Familiarity with Veeva Vault, LMS platforms, QMS tools, and other digital quality and compliance systems. - **Analytical and Organizational Skills:** Strong problem-solving, risk assessment, data analysis, and prioritization capabilities, with the ability to manage multiple projects and competing deadlines. - **Communication and Leadership:** Excellent written and verbal communication skills, strong stakeholder management abilities, and the capacity to influence cross-functional teams without direct authority. - **Personal Attributes:** High attention to detail, integrity, accountability, adaptability, and a commitment to quality and continuous improvement in a dynamic, regulated environment. **Preferred qualifications include:** - Experience in biologics, vaccines, mRNA, or advanced therapeutics. - Experience supporting global compliance initiatives across multiple regions or functional areas. - Demonstrated success in process improvement, risk management, and operational excellence initiatives. - Familiarity with digital quality management tools and the ability to drive adoption of standardized processes. ## Benefits - Health, vision, and dental insurance. - Retirement savings plan with employer matching contributions (401(k), where applicable). - Tuition reimbursement and professional development opportunities. - Paid vacation, holidays, and sick leave. - Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA), where applicable. - Work-life balance initiatives and a flexible remote working environment. - Pet insurance. - Potential eligibility for additional incentives, bonuses, or other compensation programs, depending on the role and applicable arrangements. - Competitive salary based on experience, education, skills, professional achievements, and location.