Parexel
10,000+ employees
Founded 1983
⚕️ Healthcare Insurance
🧬 Biotechnology
💊 Pharmaceuticals
💰 Venture Round on 1990-01
Healthcare Insurance • Biotechnology • Pharmaceuticals
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.
Regulatory Affairs Consultant – Compliance, Process
🔥 0 minutes ago
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Parexel
10,000+ employees
Founded 1983
⚕️ Healthcare Insurance
🧬 Biotechnology
💊 Pharmaceuticals
💰 Venture Round on 1990-01
Healthcare Insurance • Biotechnology • Pharmaceuticals
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 SME for controlled document management, ensuring compliant governance and inspection readiness • Author, review, approve, and manage controlled procedures and quality documents per GxP requirements • Drive document lifecycle management activities including creation, revision, periodic review, and archival • Provide guidance on procedural writing standards and document management best practices • Support GxP training governance to ensure compliance with regulatory requirements • Maintain effective training curricula aligned with role-based responsibilities and procedural updates • Monitor training compliance metrics and support remediation of non-compliant records • Lead regulatory compliance activities across global GxP operations • Drive inspection readiness initiatives and support FDA, EMA, MHRA, and other health authority inspections • Monitor evolving regulatory requirements and implement compliance strategies • Support development of remediation plans for audit findings and compliance gaps • Manage QMS processes including deviations, CAPAs, change controls, SOP management, and document control • Utilize metrics and trend analysis to identify compliance risks and drive continuous improvement • Support harmonization of quality processes to improve scalability and effectiveness
🎯 Requirements
• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or related field • 8+ years in Regulatory Compliance, Quality Assurance, or related GxP functions in pharma/biotech • Strong knowledge of FDA, EMA, ICH, and global GxP regulations • Experience supporting regulatory inspections and audit management • Hands-on experience with controlled document management and eDMS platforms • Experience with GxP training governance and learning management systems • Strong analytical, communication, and stakeholder management skills • Ability to manage multiple priorities in fast-paced environments • Experience in biologics, vaccines, or advanced therapeutics (preferred) • Experience supporting global compliance initiatives across multiple regions • Familiarity with Veeva Vault • Fluent in English written and spoken
🏖️ Benefits
• GxP training governance • Training compliance metrics monitoring • Quality Management System (QMS) processes management
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