Regulatory Affairs Specialist Bulgaria

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.

Requirements

• University degree in Life Science/Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering) field
• Fluent English language and Bulgarian language
• 2 years experience in Regulatory Affairs with medicinal products, medical devices, food supplements and cosmetics
• Attention to detail and time-management skills

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Company Intel

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