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

Location: REMOTE, United Kingdom, London, England, United Kingdom, Remote, Croatia, City of Zagreb, Croatia, Prague, Hlavní město Praha, Czechia, Czechia, Budapest, Budapest, Hungary, Hungary, Milan, Lombardy, Italy, Italy, Poland, Warsaw, Mazovia, Poland, Bucharest, București, Romania, Romania, Belgrade, Central Serbia, Serbia, Serbia, Madrid, Spain, Spain

Employment Type: Remote

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:

• Bachelors 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

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