Regulatory Affairs Consultant – Compliance & Process

**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 **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