Director of Regulatory Affairs - Pharmaceutical

Client of Davidson consulting

Davidson Management Consultants have been mandated to recruit a Director of Regulatory Affairs for their client in Riyadh, Saudi Arabia which is a leading biomedical and clinical research institute offering end-to-end medicine development.We are looking for western trained, native Arabic speaking Regulatory Affairs Director with a minimum of 15 to 18 years of experience in a multinational pharmaceutical manufacturing or pharmaceutical research and development facility with at least 8 years in a leadership role within Saudi Arabia.The Regulatory Affairs Director will lead the design and execution of regulatory strategies across Saudi Arabia and potentially the wider GCC region, UAE, Kuwait and Bahrain and be the primary liaison with the SFDA, managing submissions, negotiations and approvals.You will also ensure integration of the organization s international plans with local requirements. Develop functional plans and budgets for managing Regulatory Affairs activities.Collaborate with the Medical Department, Business Units Marketing and Sales teams, , Drug Safety, Quality Operations and Supply Chain to enhance life cycle management and continued market availability of products and devices across all therapeutic areas.Responsible for providing overall leadership and direction to the Regulatory Affairs team and support development and training of staff and operational planning to optimize efficiency and quality.Ensure regulatory compliance with SOPs and quality systems, including during SFDA audits or inspections.Oversees regulatory affairs activities for all investigational and marketed products and devices.Oversee compliance of labeling and artwork, including Arabic translations and alignment with SFDA labeling requirements.