- ResponsibilitiesLead and develop the local Regulatory Affairs team, setting clear goals, managing performance, and supporting training, mentoring, and resource planning.Prepare, review, and adapt CMC documentation using validated systems; monitor regulatory changes and assess impact across markets.Ensure alignment between registered dossiers and site operations; support GMP compliance, review regulated content, and assist during audits and inspections.ActResponsibilitiesLead and develop the local Regulatory Affairs team, setting clear goals, managing performance, and supporting training, mentoring, and resource planning.Prepare, review, and adapt CMC documentation using validated systems; monitor regulatory changes and assess impact across markets.Ensure alignment between registered dossiers and site operations; support GMP compliance, review regulated content, and assist during audits and inspections.Act
- ResponsibilitiesCollaborate with system owners to design and maintain compliant, efficient quality systems supporting GMS and product lifecycle.Oversee data integrity and act as system administrator for key Quality Systems.Manage site Quality System Governance, ensuring compliance with company standards and regulatory requirements.Evaluate, approve, and monitor suppliers, including managing quality agreements.Lead change control processes and handle regulaResponsibilitiesCollaborate with system owners to design and maintain compliant, efficient quality systems supporting GMS and product lifecycle.Oversee data integrity and act as system administrator for key Quality Systems.Manage site Quality System Governance, ensuring compliance with company standards and regulatory requirements.Evaluate, approve, and monitor suppliers, including managing quality agreements.Lead change control processes and handle regula
- ResponsibilitiesEnsure regulatory compliance through audits, monitoring systems, and up-to-date documentation.Manage systems, including document control, policy updates, and staff acknowledgements.Support inspections and mock audits with internal teams and external regulatory bodies.Assist in implementing and tracking quality improvement plans across all departments.Oversee daily incident reviews, support risk assessments, and promote a strong reporting cuResponsibilitiesEnsure regulatory compliance through audits, monitoring systems, and up-to-date documentation.Manage systems, including document control, policy updates, and staff acknowledgements.Support inspections and mock audits with internal teams and external regulatory bodies.Assist in implementing and tracking quality improvement plans across all departments.Oversee daily incident reviews, support risk assessments, and promote a strong reporting cu
