Regulatory Affairs Specialist Ukraine
Biomapas · Kyiv
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