Head of Regulatory Affairs

Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.

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.
  

Job Requirements

• Bachelor’s degree in Pharmacy, Medicine, Biologics, or Chemistry; MBA or Ph.D. is a plus.
• 15+ years of experience in the pharmaceutical industry, including 3–5 years in a senior regulatory role.
• Strong leadership and team management experience, ideally across multiple locations.
• Solid understanding of regional regulatory frameworks and product commercialization.
• Skilled in change management and strategic planning.
• Proficient in MS Office and electronic regulatory systems.
• Fluent in English (spoken and written).