Regulatory Affairs Specialist Bulgaria

Remote from: Bulgaria
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: 21 May 2026
Apply before: 21 Jun 2026
Experience level: Midweight
Views / Applies: 10 / 3

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

Pharmaceuticals
2011

AI Summary

This Regulatory Affairs Specialist position is a full-time remote role based in Bulgaria, focusing on regulatory support for a product portfolio including medicinal products, medical devices, food supplements, and cosmetics. Responsibilities include dossier submissions, communication with authorities and clients, reviewing promotional materials, and ensuring compliance with SOPs. The ideal candidate holds a life science degree, has 2+ years of RA experience, and is fluent in English and Bulgarian. The role offers an international team environment, professional growth, and benefits such as health insurance and performance bonuses.

Job Complexity

Easy Hard

AI Insight The role requires 2 years of experience and specific regulatory knowledge, which is moderately demanding, but the remote nature and clear responsibilities make it accessible for mid-level professionals.

Salary Analysis

AI Insight No salary is specified in the job listing. For a Regulatory Affairs Specialist in Bulgaria, the estimated market range is between 35,000 and 55,000 USD annually, with a median around 40,000 USD. This is typical for mid-level roles in the region.

Key Skills

Regulatory Affairs Medicinal Products Medical Devices Food Supplements Cosmetics EU Regulations Compliance Life Sciences Document Management Communication Skills

Cover Letter Sample

Dear Hiring Manager,

I am writing to express my strong interest in the Regulatory Affairs Specialist position at Biomapas. With a degree in Pharmacy and over 3 years of experience in regulatory affairs for medicinal products and medical devices, I am confident in my ability to support your product portfolio effectively.

In my previous role, I successfully managed dossier submissions and maintained compliance with local and EU regulations. My fluency in English and Bulgarian, along with my attention to detail, ensures seamless communication with authorities and clients.

I am particularly drawn to this opportunity because of the international team environment and the chance to contribute to regulatory intelligence. I am eager to bring my problem-solving skills and regulatory expertise to your team.

Thank you for considering my application. I look forward to the possibility of discussing how I can support Biomapas's regulatory affairs.

Sincerely,
[Your Name]

Possible Interview Questions

Can you describe your experience with regulatory submissions for medicinal products?

I have prepared and submitted multiple MAAs and variations for medicinal products in the EU, ensuring compliance with EMA guidelines and local requirements. I coordinated with cross-functional teams to compile dossiers and responded to health authority questions.

How do you stay updated on changing regulations in the EU?

I regularly monitor EMA and national authority websites, subscribe to regulatory newsletters, and participate in industry webinars. I also maintain a database of regulatory updates relevant to our product portfolio.

Describe a time you had to manage a challenging regulatory issue. How did you resolve it?

Once, we faced a delay in approval due to incomplete data. I analyzed the deficiency, coordinated with the R&D team to generate the required data, and submitted a timely response, resulting in approval within the revised timeline.

How would you ensure compliance with SOPs while working remotely?

I would meticulously follow the provided SOPs and maintain a daily checklist. I would also participate in all training sessions and use shared systems to document tasks, ensuring transparency and traceability.

What experience do you have with reviewing advertising materials for regulatory compliance?

In my previous role, I reviewed promotional materials for medical devices and cosmetics, verifying claims against approved labeling and EU regulations. I worked with marketing to ensure all materials were compliant before release.

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