Location: Kyiv, 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
Requirements
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
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
Rewarding referral policy
Team building, global meetings
Контакты работодателя доступны по кнопке «Откликнуться» после входа.
УдалённоUnited States; Canada; London; A collaborative and pragmatic approach, with comfort moving between different subject areas and working across functions, jurisdictions and time zones; We strive to create an inclusive work environment for all; we welcome applicants from all backgrounds and are committed to providing equal opportunities