Regulatory Affairs Specialist

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.

Responsibilities:

• Manage registration related activities for LT and the other EU countries
• Compile and submit applications for registration, renewals, variations in accordance with 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

• University degree in Life Science field

• Fluent English language
• 1-3 years’ experience in Regulatory Affairs with medicinal products
• Experience with medical devices and marketing material review is advantage
• Time management skills
• Ability to solve problems and make decisions

Benefits

• Professional growth and career opportunities
• International team and environment
• Bonus based on annual performance
• Personal accident and business trip insurance
• Additional health insurance
• Remote/home based
• Influenza vaccines
• Rewarding referral policy
• Team building, global meetings, B active events