Head of RA Egypt 100% (m​/f​/d

This role requires a transformative leader to elevate the Regulatory Affairs organization in Egypt, ensuring full regulatory compliance while enabling business growth through new products, customers, geographies, and processes.

The role provides strategic and technical regulatory expertise, guiding teams to lead with science and implement a patient-focused strategy that enhances access to treatments. It also develops budgets, policies, and procedures to strengthen the functional infrastructure and oversees critical systems in line with international, regional, and company regulations, standards, and procedures.

• Oversee all RA activities in EGYPT and ensure that those activities are conducted in compliance with local regulations and company policies and SOPs.
• Support the Business through strong cross-functional collaboration.
• Act as part of the Regional Leadership Team and the strategic management of the business.
• Provides strategic and technical regulatory leadership, expertise, and advice to the organization, including commercial operations, quality, and other groups at the manufacturing and supply organization and the country-based teams.
• Develops budget/procedures to support the functional infrastructure.
• Lead and manage the RA team across the EGYPT region.
• Strategically advise the multidisciplinary teams on the regulatory requirements to support the business in a compliant way.
• Assess the company’s compliance with local regulations. Develop procedures to ensure regulatory and safety compliance is met and is in line with local and company regulations.
• Develop and implement regulatory operating guidelines/Standard Operating Procedures (SOPs) and common work practices/strategies within the team, including the maintenance of a proper archiving system.
• Ensure adherence to SOPs and that employees are trained accroding to internal regulatory and safety SOPs.
• Lead by ethical principles all RA functions in the region and maintain a positive team spirit.
• Continuously develops staff by making accurate assessments of individuals’ capabilities and performance, and providing feedback, coaching, guidance, and mentoring.
• Provide recommendations to decision makers on regulatory, pharmacovigilance, and options on new products or claims that balance business needs with regulatory oversight. Able to manage assigned budgets effectively and maximize investments.
• Interface with Global RA, QA and PV functions to ensure that all activities performed in EGYPT are in compliance with the global standards.
• Ensure cross-functional collaboration with commercial and supply chain to ensure the continuity of supply and no business interruption during the submission of regulatory changes in the corresponding country.
• Ensure new opportunities and projects are properly evaluated from a regulatory and safety perspective: due diligence process is in place and due diligence is performed before entering into agreement with any business partner or service provider.
• Support and ensure that inspection from regulatory authorities or audits of commercial partners are well prepared and conducted and support the preparation of corrective and preventive action plans as appropriate.
• Contribute to Health Authorities inspections and follow-up on corrective and preventive actions.
• Ensure good marketing practice of the marketed Arcera products in EGYPT.
• Support Scientific activities related to the registered Acino products and participate in Scientific conferences and trainings.
• Contribute to spreading health awareness and pharmaceutical education in EGYPT.
• Follow-up on the importation and exportation of Arcera products.
• Adhere to Arcera internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.
• Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.

• Leadership capabilities with ability to identify and develop talents for current and future roles.
• Full understanding of legal/compliance environment and requirements.
• Full knowledge and understanding of the different health care systems/sectors in EGYPT and international.
• Ability to learn about new technologies, strategies and policies, with high level of compliance with policies.
• Ability to create business relationships with internal and external customers and colleagues in different functions.
• Proven ability to effectively work collaboratively in cross functional teams.
• Strong leadership skills and business acumen.
• Ability to remotely manage people.
• Ability to work in a highly dynamic business environment.
• Excellent oral and written communication and problem-solving skills.

• Strategic ability to manage complex stakeholder relationships and integrate diverse business interests.
• An original thinker with growth mindset with ability to lead effectively regional project teams and organization…