Regulatory Affairs Specialist - Who

When our values align, there's no limit to what we can achieve. Are you a talented Regulatory Affairs professional with experience in project management, Veeva Vault, MAA, and WHO exposure? We are currently seeking a Regulatory Affairs Associate or Senior Associate to join our dynamic team. In this client-dedicated role, you will be responsible for supporting various regulatory activities, including system implementation, WHO regulatory activities, drafting documents, managing submissions, and maintaining communication traceability. If you are a proactive individual with a strong attention to detail and a passion for delivering high-quality work, we would love to hear from you.This role can be home or office based in various European locations.Job Responsibilities:Collaborate with the team to support Regulatory Affairs system implementation activities.Provide support for WHO regulatory activities, including preparation and submission of documents, planning and tracking activities, mapping submissions, archiving information, and following KPIs.Investigate and solve any issues that may arise during regulatory processes.Support regulatory exception vaccine supply management and WHO projects.Draft requested documents such as charts, communications, and presentations.Lead meetings and share meeting minutes.Maintain communication traceability with WHO and UN agencies using Regulatory Vault system.Manage exception forms for vaccines supply in SharePoint.Handle WHO specific submissions and routine requests.Support the WHO annual report process.Monitor planning and timelines for regulatory activities.Skills and Experience required for the role: University degree in a scientific fieldA few years of working experience in Regulatory AffairsExperience with MAA, specifically in the context of vaccinesPrevious exposure to WHO regulatory processes - preferredGood understanding of system implementation principlesPrevious experience in project management.Proficiency in working with Veeva VaultProactive and detail-oriented approach to workExcellent communication and organizational skillsFluent in English, written and spoken