Regional Regulatory Affairs Specialist

Qualifications and Skills:

• Bachelor's degree in Pharmaceutical Sciences (Pharmacy) or equivalent


• 0-2 years of experience in the pharmaceutical field


• Proficiency in English and Arabic languages


• French language proficiency is a Must


• Excellent communication skills as he/she will deal with internal & external stakeholders


• Time management abilities


• Attention to detail


• Very well organized

Key Responsibilities:

• Prepare regulatory documentation for new product registrations and maintenance activities


• Ensure adherence to regulatory requirements across the MEAR region


• Manage the regulatory documentation database


• Assist in compiling necessary regulatory reports


• Submit regulatory documents accurately and promptly to regulatory agencies


• Follow up on submissions with health authorities and local representatives


• Collaborate effectively with internal and external stakeholders from various functions such as QA, Supply Chain, Medical...etc


• Implement and uphold regulatory systems and programs following company policies and SOPs


• Support business and supply continuity by providing essential regulatory assistance for tenders and supply operations