Regulatory Affairs Specialist

2 days ago

Abuja, FCT, Nigeria Afro-REACH Clinical Research Organization Full time ₦900,000 - ₦1,200,000 per year

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 files
  • Strong understanding of Regulatory Compliance, Regulatory Requirements, and their application in clinical research
  • Expertise in Regulatory Affairs, including managing interactions with local and international regulatory authorities
  • Excellent organizational and communication skills
  • Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field
  • Previous experience in regulatory roles within clinical research or healthcare industries is advantageous
  • Ability to work independently as well as in a team-oriented environment

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