Our company is seeking professional with proven experience in Ethiopian pharmaceutical regulatory affairs officer who assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, other medical equipments. Typically, individuals in these positions work within an office of regulatory affairs where they work on document preparation, facilitate registration of pharmaceuticals and other related tasks. Part of their strategic directive is to achieve a balance between our company and supplier’s responsibility to be achieved by fulfilling regulatory concerns.

Regulatory Affairs must understand all aspects of product registration process, including, laws and regulations EFDA, and approval processes. In addition, they determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.

Job Summary

• Identify and interpret relevant regulatory guidelines that used for each type of product to be registered
• Explain regulations, policies, or procedures of EFDA to concerned bodies
• Maintain data in information systems or databases of supplier
• Compile product registration dossiers of suppliers for submissions
• Ensure compliance of the documents  with regulations of EFDA and be updated with new laws and regulations released
• Facilitate registration  of pharmaceutical products and follow approval of application process
• Evaluate applicable laws and regulations to determine impact on company activities
• Coordinate regulatory documentation activities
• Follow and facilitate  all payments related to registration
• Establish and maintain effective relationships with all stakeholders

• A Bachelor’s degree in pharmacy with proven 5 years of experience in pharmaceutical regulatory area.
•  Good time management skills that used to able to work effectively in a demanding environment where strict timelines and protocols must be met
• Proficiency and familiarity with IT skills particularly databases or other information management tools that used for  managing and documenting information
• Well-developed analytical and problem solving skills and the ability to pay particular attention to details
• Well-developed written and oral communication and interpersonal skills to frequently work with suppliers, and also advise others on compliance and regulatory matters
• Understanding of both legal and scientific matters
• The ability to grasp new concepts quickly and to assimilate and evaluate scientific data
• Strong negotiation and diplomacy skills
• The ability to work under pressure and to strict deadlines
• Team-working skills and the ability to lead and motivate others
• Integrity and a professional approach to work
• Experience in pharmaceuticals sales is a plus.