Regulatory Affairs Consultant – Compliance & Process (Multiple Eu locations, home or office based)

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 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 Required For The Role

• 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