Regulatory Affairs Member

This is a fully remote position, open to applicants in Bulgaria.

📋 Description

• Identify and convey new Bulgarian laws, amendments, guidelines, and forthcoming regulatory developments.

• Offer specialized insights on Bulgarian regulatory requirements.

• Oversee EU regulatory submissions (DCP / MRP / National procedures).

• Evaluate and approve mock-ups (artwork review).

• Assess and authorize translations of product information texts.

• Review and sanction promotional materials to ensure compliance with local regulations.

• Provide the scientific expertise necessary for the successful execution of Excelya’s projects.

⛳️ Requirements

• Bachelor's degree in Life Sciences.

• Minimum of 3 years of experience in Regulatory Affairs.

• Strong knowledge of local regulatory requirements for pharmaceutical products intended for human use and medical devices.

• Experience with EU regulatory submissions (DCP / MRP / National procedures).

• Solid understanding of the EU regulatory framework and local regulations in Bulgaria.

• Detail-oriented with a strong compliance mindset.

• Experience collaborating with pharmaceutical companies or regulatory consultancies.

• Capable of working independently and producing high-quality results within tight deadlines.

• Proficient in both English and Bulgarian.

🏝️ Benefits

• Exceptional employee experience.

• High-impact projects.

• Opportunities for talents to excel.

• Chance to push boundaries and enhance patients’ journeys.