Afro-REACH Clinical Research Organization

Regulatory Affairs Specialist

Posted: 4 days ago

Job Description

Company Description Afro-REACH Clinical Research Organization (CRO) specializes in facilitating clinical trials for Sickle Cell Disease in Sub-Saharan Africa. The company provides expertise in patient recruitment, shipping logistics, regulatory processes, and engaging with Key Opinion Leaders (KOLs). Afro-REACH is committed to streamlining clinical research operations to achieve successful outcomes. Our dedicated team ensures efficiency and compliance across all aspects of clinical trial management in the region. Role Description This is a full-time, on-site role for a Regulatory Affairs Specialist based in Abuja. The Regulatory Affairs Specialist will handle the preparation and submission of regulatory documentation, ensure compliance with regulatory requirements, and oversee regulatory processes for clinical trials. Responsibilities include creating and maintaining regulatory submission timelines, ensuring adherence to local laws, and serving as the primary liaison with regulatory authorities to facilitate approvals. The role requires a high degree of organization, attention to detail, and collaboration with cross-functional teams. Qualifications Proficiency in Regulatory Documentation, Regulatory Submissions, and developing comprehensive regulatory filesStrong understanding of Regulatory Compliance, Regulatory Requirements, and their application in clinical researchExpertise in Regulatory Affairs, including managing interactions with local and international regulatory authoritiesExcellent organizational and communication skillsBachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related fieldPrevious experience in regulatory roles within clinical research or healthcare industries is advantageousAbility to work independently as well as in a team-oriented environment

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