Overview

Parexel is 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.

This role is open across multiple EU locations and can be home or office based.

Key Responsibilities

Controlled Document Management & Governance

• •Serve as SME for controlled document management, ensuring compliant governance and inspection readiness
• •Author, review, approve, and manage controlled procedures and quality documents per GxP requirements
• •Drive document lifecycle management activities including creation, revision, periodic review, and archival
• •Provide guidance on procedural writing standards and document management best practices

Training Governance & Compliance

• •Support GxP training governance to ensure compliance with regulatory requirements
• •Maintain effective training curricula aligned with role-based responsibilities and procedural updates
• •Monitor training compliance metrics and support remediation of non-compliant records
• •Support inspection readiness activities related to training documentation and personnel qualification

Regulatory Compliance & Inspection Readiness

• •Lead regulatory compliance activities across global GxP operations
• •Drive inspection readiness initiatives and support FDA, EMA, MHRA, and other health authority inspections
• •Monitor evolving regulatory requirements and implement compliance strategies
• •Support development of remediation plans for audit findings and compliance gaps

Quality Systems & Operational Excellence

• •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

Skills and Experience

• •Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or related field
• •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