Associate Manager Regulatory Affairs

Job Description SummarySupports MEA Regional Director of Regulatory Affairs & Scientific Office.Ensure product regulatory compliance with applicable regulations and standards in MEA.Main Responsibilities / Job ExpectationsWorks autonomously, but in alignment with MEA Regional Director of Regulatory Affairs & Scientific Office, to oversee day-to-day Regulatory Affairs activities for specific area(s) of responsibility.Regulatory OperationsSupports MEA Regional Director of Regulatory Affairs & Scientific Office with the following activities but not limited to:Supports the coordination, compilation and submission of regulatory submissions for new and/ or renewal of registration, responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines and the country specific requirements. Regular follow-up on submitted dossiers within responsibility. Interacts with internal and/or external stakeholders.Ensures proper archiving for submitted and/ or approved regulatory activities in-line with effective SOPs and Ipsen s ways of working. Update the applicable, internal trackers and/or database.EducationPharmacy bachelor's degree is a must.Experience3 - 6yrs regulatory experience in healthcare and/or pharmaceutical industry is a must.LanguagesArabic and English are must. Additional languages will be a plus.Key Technical Competencies RequiredGood working knowledge with Ms-Office.Good understanding of the regulations.Acts with integrity.Provides solutions to a variety of problems of limited scope and complexity.Agility.