21 set - Italia
Parexel
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world'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. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will agevolazioni a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
We are seeking a highly collaborative Regulatory Affairs Consultant –Compliance & Process 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. Key ResponsibilitiesControlled Document Management & GovernanceServe as SME for controlled document management, ensuring compliant governance and inspection readinessAuthor, review, approve,
and manage controlled procedures and quality documents per GxP requirementsDrive document lifecycle management activities including creation, revision, periodic review, and archivalProvide guidance on procedural writing standards and document management best practicesTraining Governance & ComplianceSupport GxP training governance to ensure compliance with regulatory requirementsMaintain effective training curricula aligned with role-based responsibilities and procedural updatesMonitor training compliance metrics and support remediation of non-compliant recordsSupport inspection readiness activities related to training documentation and personnel qualificationRegulatory Compliance & Inspection ReadinessLead regulatory compliance activities across global GxP operationsDrive inspection readiness initiatives and support FDA, EMA, MHRA, and other health authority inspectionsMonitor evolving regulato
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