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

Remote from: Romania
Annual salary: Undisclosed
Salary information is not provided for this position. Check our Salary Directory to estimate the average compensation for similar roles.
Department: Legal & Compliance
Employment type: Full Time,
Job posted: 9 Jun 2026
Apply before: 9 Jul 2026
Experience level: Senior
Views / Applies: 34 / 12

Big Enough To Cover All Your Needs. Small Enough To Care.

Pharmaceuticals
2011

AI Summary

This is a freelance, part-time (0.1 FTE) opportunity for a Local Regulatory Affairs Specialist based in Romania. The role involves ensuring compliance with local regulations for medicinal products, medical devices, and food supplements, including managing submissions, reviewing labeling, and communicating with authorities. Candidates need a life science degree, fluency in English and Romanian, and at least 2 years of local regulatory experience. The position is remote and requires close collaboration with the global regulatory team.

Role DNA

Job Complexity

Easy Hard

Pace & Pressure

Relaxed Fast-paced

Autonomy Level

Guided Full Ownership

Communication Load

Independent Highly Collaborative

AI Insight The role requires specialized knowledge of Romanian and EU regulations, but the required experience is only 2 years, making it moderate difficulty.

Salary Analysis

AI Insight The salary for this position is not specified, but based on a US market estimate for a full-time Regulatory Affairs Specialist (median $75,000), the pro-rated salary for this 0.1 FTE freelance role would be approximately $7,500 annually. Part-time freelance roles often offer flexibility but may lack benefits.

Key Skills

Regulatory Affairs Romanian Regulations EU Regulations Medicinal Products Medical Devices Food Supplements Regulatory Submissions Compliance Translations Proofreading

Cover Letter Sample

Dear Hiring Manager,

I am writing to express my strong interest in the Local Regulatory Affairs Specialist freelance position. With a degree in Pharmacy and over 3 years of experience navigating Romanian regulatory frameworks for medicinal products and medical devices, I am confident in my ability to ensure full compliance and support your global team effectively.

In my previous role, I successfully prepared and submitted multiple marketing authorization applications and managed post-authorization changes, maintaining excellent relationships with the National Agency for Medicines and Medical Devices. My fluency in Romanian and English, combined with meticulous attention to detail, allows me to handle translations and regulatory reviews with precision.

I am excited about the opportunity to contribute to your organization's regulatory strategy and would welcome the chance to discuss my qualifications further. Thank you for considering my application.

Sincerely,
[Your Name]

Possible Interview Questions

What experience do you have with Romanian regulatory submissions for medicinal products?

I have prepared and submitted several marketing authorisation dossiers for new and generic products, including eCTD submissions, and managed variations and renewals in accordance with national and EU guidelines.

How do you stay updated on changes in local regulatory requirements?

I regularly monitor updates from the National Agency for Medicines and Medical Devices of Romania (NAMMDR) and subscribe to regulatory newsletters and professional networks to ensure timely awareness of changes.

Describe a challenging regulatory issue you resolved in your previous role.

I once handled a complex post-authorization change that required rapid re-evaluation of a product's safety data. I coordinated with the clinical team, prepared a robust variation submission, and obtained approval within a tight deadline.

How do you manage multiple regulatory projects simultaneously given this is a part-time role?

I prioritize tasks based on deadlines and impact, use project management tools to track progress, and communicate proactively with the global team to align expectations and ensure timely delivery.

Can you explain the key differences in regulatory requirements for medical devices vs. medicinal products in Romania?

Yes, medicinal products require marketing authorisation from NAMMDR following EU procedures, while medical devices need CE marking and registration with the competent authority. Post-market surveillance and vigilance reporting also differ, and I have experience managing both pathways.

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 now >