Parexel
Regulatory Affairs Consultant – Compliance & Process (Multiple Eu locations, home or office based)
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When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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
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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
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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
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