Regulatory Affairs Specialist Ukraine

Ukraine·KyivFull-timemid

Legal & ComplianceRegulatory Affairs Specialist

0 views0 saves0 applied

Apply Now

Quick Summary

Key Responsibilities

Prepare and maintain regulatory submissions, registrations, renewals, variations for medicinal products and medical devices, and notifications for food supplements Ensure compliance of products,

Technical Tools

Legal & ComplianceRegulatory Affairs Specialist

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

Responsibilities

~1 min read

→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

~1 min read

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