Join our global team as a (Senior) Regulatory Affairs Specialist in Lithuania.
(Senior) 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.
Responsibilities:
• 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), labelling etc.
• Prepare financial report for assigned projects
• Participate in Standard Operating Procedures creation
Requirements:
• 2-4 years experience in Regulatory Affairs with medicinal products
• Fluent English and Lithuanian language
• Experience with Promotional materials
• University degree in Life Science field
• Medical devices experience is advantage
• Ability to solve problems and make decisions
• Time management skills
Benefits of being part of our 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
