Regulatory Affairs Member
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Job Description
Part-time Regulatory Affairs freelancer supporting Excelya’s Bulgarian pharmaceutical and medical-device projects. Managing EU submissions and approving local regulatory materials.
Responsibilities:
- Identify and communicate new Bulgarian legislation, amendments, guidelines and upcoming regulatory developments.
- Provide expert input on Bulgarian regulatory requirements.
- Manage EU regulatory submissions (DCP / MRP / National procedures).
- Review and approve mock-ups (artwork review).
- Review and approve translations of product information texts.
- Review and approve promotional materials in compliance with local regulations.
- Provide scientific expertise required for the successful completion of Excelya’s projects.
Requirements:
- Degree in Life Sciences.
- At least 3 years of experience in Regulatory Affairs.
- Strong familiarity with local Regulatory requirements for pharmaceutical products for human use and medical devices.
- Experience in EU regulatory submissions (DCP / MRP / National procedures).
- Good understanding of EU regulatory framework and local regulations in Bulgaria.
- Detail-oriented with strong compliance mindset.
- Experience working with pharmaceutical companies or regulatory consultancies.
- Able to work independently and deliver high-quality results within tight timelines.
- Fluent in English and Bulgarian language.
Benefits:
- Best employee experience
- High-impact projects
- Space for talents to shine
- Opportunity to push boundaries and elevate patients’ journeys
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