Regulatory Affairs Specialist Bulgaria

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

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 Good communication and writing skills Problems solving skills, ability to work independently and within the team Benefits International team and environment Professional growth and career opportunities Bonus based on annual performance Additional bonus system – Instant reward and Recognition program Personal accident and business trip insurance Additional health insurance Influenza vaccines Rewarding referral policy Workplace establishment allowance