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