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 Lithuania.
• Manage registration related activities for LT and the other EU countries
• Compile and submit applications for registration, renewals, variations in accordance to the national legislation
• Maintain contact with regulatory authorities, client representative
• Update and collect information on registration instructions and regulations
• Translate/update the specific product dossier documents, i.e. Summary of Product Characteristics (SPC), Patient Information Leaflet (PIL), labeling, etc.
• Prepare financial reports for assigned projects
• Participate in Standard Operating Procedures creation
• University degree in Life Science field
• Fluent English language
• 2-4 years experience in Regulatory Affairs with medicinal products
• Experience with medical devices and marketing material review is an advantage
• Time management skills
• Ability to solve problems and make decisions
Benefits of being part of the team:
• Personal and professional development
• Additional benefits (bonus system, additional health insurance and etc.)
• International team spirit
• Modern and new office in Kaunas with partly remote work possibility
Biomapas is a functional and full outsourcing solution provider to the global life science industry, with key expertise in Clinical Trials, Regulatory Affairs, Pharmacovigilance and Medical Information. 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.