Join our global team as a Regulatory Affairs Specialist. Regulatory Affairs Specialist is responsible for assigned project and related tasks, applications and dossiers submissions, communication with clients and national authorities. Position is full-time remote/home-based in Bulgaria. All CV's must be submitted in English language for the assessment. Responsibilities: Regulatory Affairs support for the dedicated product portfolio (MP, MD, FS, cosmetics) including interactions with authorities, local documents provisions, procedures management, artwork, PI update, translations, systems and databases update Regulatory Affairs support for the other affiliate functions Review of advertising and promotional materials regarding regulatory compliance Work according to the standard operating procedures provided by Biomapas/Client, follow updates and participate in the training Ensure timely reporting and updating of regulatory data within Client systems. Support of the team during audit/inspections Provision of Regulatory Intelligence Support Biomapas Clients with other RA related tasks, including strategic and operational regulatory advice.
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