# Regulatory Affairs Specialist Bulgaria

**Company:** [Biomapas](http://jobs.workable.com/companies/8iejh2fCgUzZGK2eUKBree.md)
**Location:** Remote
**Workplace:** remote
**Employment type:** Full-time
**Department:** PV/RA/MI Operations

[Apply for this job](http://jobs.workable.com/view/806d5318-e127-4b9d-a794-0071b2ba71f9)

## Description

### Join our global team as a Regulatory Affairs Specialist.

**Regulatory Affairs Specialist** is responsible for assigned project and related tasks, applications and dossiers submissions, communication with clients and national authorities.

**Position is full-time remote/home-based in Bulgaria.**

_All CV's must be submitted in English language for the assessment._

### Responsibilities:

-   Regulatory Affairs support for the dedicated product portfolio (MP, MD, FS, cosmetics) including interactions with authorities, local documents provisions, procedures management, artwork, PI update, translations, systems and databases update
-   Regulatory Affairs support for the other affiliate functions
-   Review of advertising and promotional materials regarding regulatory compliance
-   Work according to the standard operating procedures provided by Biomapas/Client, follow updates and participate in the training
-   Ensure timely reporting and updating of regulatory data within Client systems.
-   Support of the team during audit/inspections
-   Provision of Regulatory Intelligence
-   Support Biomapas Clients with other RA related tasks, including strategic and operational regulatory advice.

## Requirements

-   University degree in Life Science/Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering) field
-   Fluent English language and Bulgarian language
-   2 years experience in Regulatory Affairs with medicinal products, medical devices, food supplements and cosmetics
-   Attention to detail and time-management skills
-   Good communication and writing skills
-   Problems solving skills, ability to work independently and within the team

## Benefits

-   International team and environment
-   Professional growth and career opportunities
-   Bonus based on annual performance
-   Additional bonus system – Instant reward and Recognition program
-   Personal accident and business trip insurance
-   Additional health insurance
-   Influenza vaccines
-   Rewarding referral policy
-   Workplace establishment allowance