Regulatory Affairs Consultant – Compliance & Process

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 benefit 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 collaborativeRegulatory Affairs Consultant –Compliance & Processto 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.This is a client dedicated project and can be based remotely of from one of our offices.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 regulatory requirements and implement compliance strategiesSupport development of remediation plans for audit findings and compliance gapsQuality Systems & Operational ExcellenceManage QMS processes including deviations, CAPAs, change controls, SOP management, and document controlUtilize metrics and trend analysis to identify compliance risks and drive continuous improvementSupport harmonization of quality processes to improve scalability and effectivenessSkills and Experience required for the role:Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or related field8+ years in Regulatory Compliance, Quality Assurance, or related GxP functions in pharma/biotechStrong knowledge of FDA, EMA, ICH, and global GxP regulationsExperience supporting regulatory inspections and audit managementHands-on experience with controlled document management and eDMS platformsExperience with GxP training governance and learning management systemsStrong analytical, communication, and stakeholder management skillsAbility to manage multiple priorities in fast-paced environmentsExperience in biologics, vaccines, or advanced therapeutics (preferred)Experience supporting global compliance initiatives across multiple regionsFamiliarity with Veeva VaultFluent in English written and spokenOriginally posted on Himalayas