Regulatory Affairs Specialist Ukraine

• Join our global team as a Regulatory Affairs Specialist in Ukraine.
• Regulatory Affairs Specialist is responsible for assigned projects and related tasks, applications and dossiers submissions, communication with clients and national authorities.
• Position is in Ukraine, Kyiv.
• All CV's must be submitted in English language for an assessment.

Responsibilities

• Prepare and maintain regulatory submissions, registrations, renewals, variations for medicinal products and medical devices, and notifications for food supplements
• Ensure compliance of products, labeling, packaging, and promotional materials with Ukrainian regulations
• Monitor regulatory changes and assess their impact on the product portfolio
• Liaise with regulatory authorities and external partners
• Support product launches, lifecycle management activities, and compliance initiatives
• Support pharmacovigilance activities, including the submission of safety-related documentation to regulatory authorities.
• Coordinate implementation of safety-related labeling updates and variations
• Collaborate with local and global PV teams on safety communications, regulatory commitments, and inspection readiness
• Maintain regulatory documentation and databases
• Vendors management
• Participate in audits
• University degree in Pharmacy, Life Science, Medicine, or a related field
• Fluent English, and Ukrainian languages
• 4-5 years experience in Regulatory Affairs with medicinal products, medical devices and food supplements
• Excellent knowledge in the field of registration of medicinal products, medical devices and food supplements according to national rules
• Time management skills
• Ability to solve problems and make decisions
• 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