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 Hungary.
- Manage Medicinal Products and Medical Devices regulatory affairs related activities for Hungary and other countries
- Coordinate with experts in various countries
- Compile, coordinate and monitor applications for registration, notifications, renewals, variations/changes for medicinal products and medical devices in accordance with the national and EU legislation and standard operating procedures
- Make regulatory monitoring of the current duties related with particular product in the territory
- Maintain contact with testing/technical companies, regulatory authorities, client/sponsor representative
- Provide the Regulatory team with regulatory input in order to obtain timely regulatory approvals for the products
- Update and collect information on registration instructions and regulations
- University degree in Life Science field
- Fluent in English and Hungarian languages
- 2-3 years’ experience in Regulatory Affairs with medicinal products and medical devices
- Experience with food supplements and cosmetics is advantage
- Time management skills
- Ability to solve problems and make decisions
- Personal and professional development
- Additional benefits (bonus system, additional health insurance etc.)
- International team spirit
- Remote work
- Career opportunities