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 supplementsEnsure compliance of products, labeling, packaging, and promotional materials with Ukrainian regulationsMonitor regulatory changes and assess their impact on the product portfolioLiaise with regulatory authorities and external partnersSupport product launches, lifecycle management activities, and compliance initiativesSupport pharmacovigilance activities, including the submission of safety-related documentation to regulatory authorities. Coordinate implementation of safety-related labeling updates and variationsCollaborate with local and global PV teams on safety communications, regulatory commitments, and inspection readinessMaintain regulatory documentation and databasesVendors managementParticipate in auditsRequirementsUniversity degree in Pharmacy, Life Science, Medicine, or a related fieldFluent English, and Ukrainian languages4-5 years experience in Regulatory Affairs with medicinal products, medical devices and food supplementsExcellent knowledge in the field of registration of medicinal products, medical devices and food supplements according to national rulesTime management skillsAbility to solve problems and make decisionsBenefitsProfessional growth and career opportunities International team and environmentBonus based on annual performancePersonal accident and business trip insurance Additional health insuranceRemote/home based Influenza vaccinesRewarding referral policyTeam building, global meetings, B active events
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
- Influenza vaccines
- Rewarding referral policy
- Team building, global meetings, B active events
Biomapas is a functional and full outsourcing solution provider to the global life science industry.
As a trusted partner for biopharmaceutical, medical device, cosmetics, and food supplement companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory and pharmacovigilance excellence across Europe, CIS, MENA, and LATAM regions through the entire product lifecycle.
Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization. Our professionals execute your projects efficiently, cost-effectively and aspire to partner with you and become an integral part of your team from Early Development to Commercial success.
Biomapas is a functional and full outsourcing solution provider to the global life science industry.
As a trusted partner for biopharmaceutical, medical device, cosmetics, and food supplement companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory and pharmacovigilance excellence across Europe, CIS, MENA, and LATAM regions through the entire product lifecycle.
Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization. Our professionals execute your projects efficiently, cost-effectively and aspire to partner with you and become an integral part of your team from Early Development to Commercial success.
