Head of Regulatory Affairs

Acino Pharma

Main duties

• Lead the regulatory function in Egypt, ensuring full compliance with local and international regulations.
• Provide strategic and technical regulatory guidance to support business growth across products and geographies.
• Actively contribute to regional leadership decisions and align regulatory activities with internal SOPs and global standards.
• Oversee all RA operations, including submissions, approvals, and lifecycle management of products.
• Interface with global RA, QA, and PV teams to ensure consistency and compliance.
• Develop and implement regulatory SOPs, guidelines, and archiving systems.
• Manage and develop the RA team, fostering a positive, ethical, and high-performance culture.
• Ensure team training and adherence to regulatory and safety procedures.
• Collaborate with commercial, supply chain, and scientific teams to support business continuity and product availability.
• Support scientific activities, health awareness initiatives, and participation in relevant conferences.
• Advise cross-functional teams on regulatory requirements and evaluate new opportunities from a compliance perspective.
• Represent the company during inspections and audits, and lead corrective and preventive action planning.
• Ensure good marketing practices and proper handling of product complaints, adverse events, and medical inquiries.
• Monitor import/export processes and ensure regulatory readiness for new projects and partnerships.