A Center of Regulatory Excellence (CoRE MENA) office in Dubai for a global pharmaceutical company that provides specialty therapies in 70 countries for more than 40 years is currently looking for hard working and committed individuals who want to take on new challenges and help us fulfill our promise to our clients. Document Specialist Drug Regulatory Affairs Your tasks: - Develop and prepare electronic documents for marketing authorizations for therapeutic products in the MENA region with a computerized document management system. - Compile electronic registration documentation as eCTD by use of an electronic submission tool and manage their life-cycle electronically. - Exchange registration documentation electronically with our head quarter and our domestic and foreign partners. - Submit regulatory documentation electronically as part of new marketing authorization applications and their maintenance. - Manage regulatory information in collaboration with our headquarter using computerized data bases and provide those information user-related. - You will work closely with our European headquarter and other partner companies.
Requirements
Pharmacy/science graduate. - Education in Regulatory Affairs. - Experience in working with databases and document management systems. - Excellent Knowledge in computer literacy and English. - 1 to 3 years experience in similar field. - Team Spirit, Initiative and the ability to coordinate complex workflows should belong to your strength. - Provide leadership and guidance in the development of strategic and operations regulatory plans designed to bring new products to regulatory submission and approval. - Will work closely with Regulatory Affairs office Director in Dubai and support the partners in the MENA region. - Excellent communication skills in English, leadership skills, details and timeline oriented and well organized.
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