# Regulatory Affairs Specialist Ukraine

**Company:** [Biomapas](http://jobs.workable.com/companies/8iejh2fCgUzZGK2eUKBree.md)
**Location:** Kyiv, Ukraine
**Workplace:** on site
**Employment type:** Full-time

[Apply for this job](http://jobs.workable.com/view/68f608ab-3607-4950-a16e-b18b699447d0)

## Description

### 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