Regulatory Affairs Specialist - Medicinal Products, Devices & Food Supplements

About the role

Biomapas is looking for a Regulatory Affairs Specialist to join its global team in Kyiv, Ukraine. The specialist handles assigned projects, applications and dossier submissions, and communicates with clients and national authorities. All CVs must be submitted in English.

Key responsibilities

• Prepare and maintain regulatory submissions, registrations, renewals, variations for medicinal products and medical devices, and notifications for food supplements
• Ensure products, labeling, packaging and promotional materials comply 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 and compliance initiatives
• Support pharmacovigilance, including safety documentation submissions, safety-labeling updates and coordination with local and global PV teams on inspections
• Maintain regulatory documentation and databases, manage vendors and participate in audits

Required profile

• University degree in Pharmacy, Life Sciences, Medicine or a related field
• Fluent English and Ukrainian
• 4-5 years of experience in Regulatory Affairs for medicinal products, medical devices and food supplements
• Excellent knowledge of registration of medicinal products, medical devices and food supplements under national rules
• Time management, problem-solving and decision-making abilities

What we offer

• Professional growth and career opportunities within an international team
• Bonus based on annual performance
• Personal accident and business trip insurance, plus additional health insurance
• Remote/home-based work
• Rewarding referral policy, team building and global meetings