# Local Regualtory Affairs Specialist in Romania (Freelance/ 0.1 FTE)

> Biomapas · Romania (Remote) · Part-time · Posted 2026-06-09

**Workplace:** remote

**Department:** Regulatory Affairs (RA)

## Description

**Freelance opportunity in Romania!** Join our global team as a Local Regulatory Affairs Specialist in Romania.

**Local Regulatory Affairs Specialist** will be responsible for ensuring that medicinal and other products comply with applicable regulatory requirements by providing input and coordinating marketing authorization and post-authorization related activities.

**The position is remote (approximately 0.1FTE) and covers Romania,** working in close collaboration with the Regulatory Affairs team.

_You have energy and motivation to work in a team and to gain more experience?_

_Submit your CV in the English language for consideration._

**Responsibilities:**

-   Act as Local Regulatory Affairs Specialist in the assigned territory.
-   Oversee and manage all local Regulatory Affairs activities related to Medicinal Products (MP), Medical Devices (MD), and Food Supplements (FS), ensuring full compliance with applicable regulatory framework.
-   Maintain timely and effective communication with local Competent Authorities.
-   Monitor and report changes in national regulatory requirements on a regular basis.
-   Develop and/or review of regulatory strategy to support product lifecycle planning, including initial market entry and post-approval changes.
-   Prepare regulatory documentation for submission to Competent Authorities. Regulatory submissions (including submission of educational materials and local notifications).
-   Regulatory review for labelling components (e.g., packaging, patient leaflets, SmPC), promotional materials, and product information to ensure full compliance with applicable regulatory requirements.
-   Translations and proofreading.
-   Ensure accurate documentation, reporting, and follow-up of all regulatory reports.
-   Support Biomapas Clients with other RA-related tasks, including strategic and operational regulatory advice.

## Requirements

-   Biologist, Pharmacist, Medical Doctor, or other life science degree
-   Fluent written and spoken English and Romanian
-   At least 2 years of experience in local regulatory affairs activities
-   Proven experience managing local Regulatory Affairs activities in Romania for MP, MD and FS
-   Experience with local documents preparation and regulatory submissions
-   Excellent knowledge of local and international regulations
-   High motivation to develop and learn within the team

## Apply

[Apply at Biomapas](https://apply.workable.com/biomapas/j/40D73391BD/apply)

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