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
