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 remote/home-based in Bulgaria. Part time role – 0,5 FTE.
Responsibilities:
• Manage registration related activities mainly for Bulgaria and EU
• Compile and submit applications for registration, renewals, variations in accordance to the national and EU legislation
• Maintain contact with regulatory authorities, client representative
• Make regulatory monitoring of the current duties related with particular product
• Participate in audits
• Translate/update the specific product dossier documents
• Update/collect information on registration instructions and regulations
Requirements:
• University degree in Life Science field
• Fluent English language and Bulgarian language
• 3-4 years experience in Regulatory Affairs with medicinal products
• Experience in Regulatory Affairs with Medical Devices
• Experience with medical devices, food supplements and cosmetics is advantage
• Time management skills
• Ability to solve problems and make decisions
Benefits of being a part of our team:
• Professional growth and career opportunities
• Supportive work environment
• Additional benefits
• Remote work
