Regulatory Affairs Consultant – Compliance & Process

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    "logoImage": {
      "alt": "Parexel",
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    "startDate": "2026-06-19",
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    "jobDescription": "<p><b>When our values align, there&#39;s no limit to what we can achieve.</b><br /> <br />At Parexel, we all share the same goal - to improve the world&#39;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.</p><p>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&#39;re committed to making a difference.</p><p></p><p></p><p>We are seeking a highly collaborative<b><span> </span>Regulatory Affairs Consultant –</b> <b>Compliance &amp; Process</b><span> </span>to strengthen global regulatory compliance and quality operations across GxP environments. You will partner with Regulatory Affairs, Quality, CMC, Clinical Operations, and other cross-functional teams to enable compliant, efficient, and scalable business operations.</p><p></p><p><u>This is a client dedicated project and can be based remotely of from one of our offices.</u></p><p></p><p>Key Responsibilities</p><p><b>Controlled Document Management &amp; Governance</b></p><ul><li><p>Serve as SME for controlled document management, ensuring compliant governance and inspection readiness</p></li><li><p>Author, review, approve, and manage controlled procedures and quality documents per GxP requirements</p></li><li><p>Drive document lifecycle management activities including creation, revision, periodic review, and archival</p></li><li><p>Provide guidance on procedural writing standards and document management best practices</p></li></ul><p><b>Training Governance &amp; Compliance</b></p><ul><li><p>Support GxP training governance to ensure compliance with regulatory requirements</p></li><li><p>Maintain effective training curricula aligned with role-based responsibilities and procedural updates</p></li><li><p>Monitor training compliance metrics and support remediation of non-compliant records</p></li><li><p>Support inspection readiness activities related to training documentation and personnel qualification</p></li></ul><p><b>Regulatory Compliance &amp; Inspection Readiness</b></p><ul><li><p>Lead regulatory compliance activities across global GxP operations</p></li><li><p>Drive inspection readiness initiatives and support FDA, EMA, MHRA, and other health authority inspections</p></li><li><p>Monitor evolving regulatory requirements and implement compliance strategies</p></li><li><p>Support development of remediation plans for audit findings and compliance gaps</p></li></ul><p><b>Quality Systems &amp; Operational Excellence</b></p><ul><li><p>Manage QMS processes including deviations, CAPAs, change controls, SOP management, and document control</p></li><li><p>Utilize metrics and trend analysis to identify compliance risks and drive continuous improvement</p></li><li><p>Support harmonization of quality processes to improve scalability and effectiveness</p></li></ul><p></p><p><b>Skills and Experience required for the role:</b></p><ul><li><p>Bachelor&#39;s degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or related field</p></li><li><p>8&#43; years in Regulatory Compliance, Quality Assurance, or related GxP functions in pharma/biotech</p></li><li><p>Strong knowledge of FDA, EMA, ICH, and global GxP regulations</p></li><li><p>Experience supporting regulatory inspections and audit management</p></li><li><p>Hands-on experience with controlled document management and eDMS platforms</p></li><li><p>Experience with GxP training governance and learning management systems</p></li><li><p>Strong analytical, communication, and stakeholder management skills</p></li><li><p>Ability to manage multiple priorities in fast-paced environments</p></li><li><p>Experience in biologics, vaccines, or advanced therapeutics (preferred)</p></li><li><p>Experience supporting global compliance initiatives across multiple regions</p></li><li><p>Familiarity with Veeva Vault</p></li><li><p>Fluent in English written and spoken</p></li></ul>",
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