Overview

In 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.

Responsabilità

- Serve 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 fondamentali

- 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

- 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) (Monza)
🏢 Parexel
📍 Monza