Regulatory Affairs Specialist Bulgaria

Biomapas

🏠 Remote
📍
Posted May 21, 2026
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Job Overview

Position

Regulatory Affairs Specialist Bulgaria

Company

Biomapas

Location

Work Type

Remote

Job ID

li-4417462156

Job 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
✦

Interview Prep

AI-powered insights to help you prepare

Key Skills

Required:
Preferred:

Practice Questions

💡Technical Questions (3)
  • 1.Can you walk me through your experience with regulatory submissions across the different product categories mentioned in the JD, specifically medicinal products, medical devices, food supplements, and cosmetics?
  • 2.How do you approach the review of advertising and promotional materials to ensure they meet regulatory compliance?
  • 3.This role requires managing local document provisions, PI updates, and translations. How do you ensure accuracy and compliance when handling translated regulatory documents in Bulgaria?
🎯Behavioral Questions (3)
  • 1.Tell me about a time you had to manage multiple regulatory submissions or projects with competing deadlines. How did you ensure everything was submitted on time?
  • 2.Describe a situation where you had to provide regulatory intelligence or strategic advice to a client or internal stakeholder that changed their approach to a project.
  • 3.Give me an example of a time you faced a difficult communication with a national authority regarding a pending application or document provision. How did you handle it?
🧩Situational Questions (2)
  • 1.You are working remotely and a client urgently needs strategic and operational regulatory advice regarding a last-minute local regulatory change affecting their cosmetic product portfolio, but your immediate team is offline. What do you do?
  • 2.You discover a discrepancy between the approved SmPC and the newly delivered artwork for a medicinal product just days before the scheduled submission to the local authority. How would you handle this?

Resume Keywords

Make sure these keywords appear on your resume

Regulatory AffairsMedicinal ProductsMedical DevicesCosmeticsFood SupplementsDossier SubmissionBulgarian Drug AgencyPromotional Material ReviewProduct Information (PI)Regulatory IntelligenceSOP ComplianceArtwork Review

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