Quality Assurance Regulatory Affairs Manager

We are looking for an experienced Quality & Regulatory Affairs Manager to lead Quality and Regulatory Affairs activities and ensure compliance with corporate, local, and international regulatory requirements.The successful candidate will play a key leadership role in establishing and maintaining robust Quality Management Systems, managing regulatory submissions and product approvals, supporting technology transfer, and ensuring inspection and audit readiness.Key Responsibilities* Lead Quality functions including QA, QC, Validation, GMP and Audits* Define and implement the local Regulatory Affairs strategy* Manage product registrations, renewals, variations and regulatory submissions* Act as the primary interface with regulatory authorities* Lead internal/external audits, inspections and corrective actions* Oversee product quality, analytical testing and data integrity* Lead validation and qualification strategies* Manage biosafety, biosecurity and biorisk management systems* Support technology transfer, plant licensing and manufacturing authorization* Lead and develop the Quality & Regulatory Affairs teamRequired Qualifications & Experience* Degree in Life Sciences; MSc/PhD preferred* 10+ years of experience in the biopharma/biotech industry* 7+ years in Quality leadership positions* Strong experience with regulatory authorities and inspections* Proven experience managing regulatory submissions and product approvals* Strong knowledge of QA, QC, Validation, GMP and Audits* Knowledge of international regulatory and biosafety standards* Strong leadership, stakeholder management and risk-based decision-making skills* High proficiency in Arabic and English, written and spoken