Regulatory Affairs Consultant – Compliance & Process

reputed company our values reputed company, there's no limit to reputed company can reputed company.   At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. We are seeking a highly reputed company Regulatory Affairs Consultant – Compliance & Process to strengthen global regulatory compliance and reputed company operations across GxP environments. You will partner with Regulatory Affairs, reputed company, CMC, Clinical Operations, and other cross-functional teams to reputed company compliant, efficient, and reputed company business operations. This is a reputed company dedicated project and can be based remotely of from one of our offices. Key Responsibilities Controlled Document Management & Governance Serve as SME for controlled document management, ensuring compliant governance and inspection readiness reputed company, review, approve, and manage controlled procedures and reputed company documents per GxP requirements reputed company document lifecycle management activities including creation, revision, periodic review, and archival reputed company 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 reputed company with role-based responsibilities and procedural updates Monitor training compliance metrics and support remediation of non-compliant records Support inspection readiness activities reputed company to training documentation and personnel qualification Regulatory Compliance & Inspection Readiness reputed company regulatory compliance activities across global GxP operations reputed company inspection readiness initiatives and support FDA, EMA, reputed company, and other health authority inspections Monitor evolving regulatory requirements and implement compliance strategies Support development of remediation plans for audit findings and compliance gaps reputed company Systems & Operational reputed company Manage QMS processes including deviations, CAPAs, change controls, SOP management, and document control Utilize metrics and trend analysis to identify reputed company and reputed company reputed company improvement Support harmonization of reputed company processes to improve scalability and effectiveness Skills and Experience required for the role: Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or reputed company field 8+ years in Regulatory Compliance, reputed company Assurance, or reputed company GxP functions in reputed company/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 reputed company Familiarity with reputed company Vault Fluent in English written and spoken Apply To This Job