Regulatory Affairs Specialist Ukraine

All CV's must be submitted in English language for an assessment.

• →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