OverviewIn this role you will strengthen global regulatory compliance and quality operations within GxP environments.
You will partner with Regulatory Affairs, Quality, CMC, Clinical Operations and other teams to enable compliant, efficient, and scalable business operations.
You will lead and support compliance initiatives, inspection readiness, and continuous improvement of quality systems.
This is a hands-on, cross-functional role that shapes how Parexel delivers compliant regulatory solutions at scale.
ResponsabilitàServe as SME for controlled document management with governance and inspection readiness
Author, review, approve, and manage controlled procedures and quality documents per GxP requirements
Drive document lifecycle management including creation, revision, review, and archival
Guide procedural writing standards and document management best practices
Support GxP training governance and maintain role-based curricula
Monitor training compliance metrics and assist remediation of non-compliant records
Support inspection readiness activities related to training documentation and personnel qualification
Lead regulatory compliance activities across global GxP operations
Drive inspection readiness and support FDA, EMA, MHRA and other health authority inspections
Monitor evolving regulatory requirements and implement compliance strategies




Develop 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
Requisiti fondamentali8+ 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
strong communication
stakeholder management
analytical thinking
GxP regulatory frameworks (FDA/EMA/ICH)
Quality Management System (QMS)
Deviation, CAPA, change control processes

📌 Regulatory Affairs Consultant – Compliance & Process (Multiple Eu Locations, Home Or Office Based) (Bardi)
🏢 Parexel
📍 Bardi