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Join our global team as a Regulatory Affairs Specialist.

Regulatory Affairs Specialist is responsible for assigned projects and related tasks, applications and dossiers submissions, communication with clients and national authorities.

Position is in Romania (Bucharest).

Responsibilities:

• Manage registration related activities mainly for Romania and EU
• Compile and submit applications for registration, renewals, variations in accordance to the national and EU legislation
• Maintain contact with regulatory authorities, client representative
• Make regulatory monitoring of the current duties related with particular product
• Participate in audits
• Translate/update the specific product dossier documents
• Update/collect information on registration instructions and regulations

Requirements:

• University degree in Life Science field
• Fluent English language
• 2-4 years experience in Regulatory Affairs with medicinal products
• Experience with medical devices, food supplements and cosmetics is advantage
• Time management skills
• Ability to solve problems and make decisions

Benefits of being part of our team:

• Bonus system
• Remote work
• International team spirit
• Personal and professional development
• Career opportunities

Biomapas is a functional and full outsourcing solution provider to the global life science industry, with key expertise in Clinical Trials, Regulatory Affairs and Pharmacovigilance. With headquarters in Lithuania and offices in Switzerland, Russia, Georgia, Ukraine, Poland, Kazakhstan and Sweden, Biomapas operations are spread over 5 continents, concentrated in Europe, Russia and former CIS region.

 

Job Category: Regulatory Affairs
Job Type: Full Time
Job Location: Romania

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