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Sobre este puesto de Mission Regulatory Affairs Member en Excelya

Excelya · Remoto · Bulgaria

Redefine Regulatory Affairs. Empower Innovation. Build with Audacity.

Join Excelya as Our Next RA Star!

At Excelya, we don’t just work—we Excelyate. Across 24 countries, 900+ passionate professionals are shaping the future of healthcare with one bold ambition: to become Europe's leading mid-size CRO, offering the best employee experience.

Now, we’re calling on curious minds and courageous spirits to step into a career-defining role in Regulatory Affairs. Ready to make an impact that travels the globe? Let’s talk.

 

About the Job

We are seeking a Freelancer Mission Regulatory Affairs Member, based in Bulgaria for a part-time, full remote role, to provide scientific expertise required for the successful completion of Excelya’s projects.

 

Your Mission:

  • To identify and communicate new Bulgarian legislation, amendments, guidelines and upcoming regulatory developments.
  • To provide expert input on Bulgarian regulatory requirements.
  • To manage EU regulatory submissions (DCP / MRP / National procedures).
  • To be responsible for the review and approval of:

o Mock-ups (artwork review)

o Translation of Product information texts

o Promotional materials in compliance with local regulations

Requirements

What You Bring to the Table:

We are looking for candidates who embody our values of Audacity, Care, and Energy and also:

  • Degree in Life Sciences.
  • At least 3 years of experience in Regulatory Affairs.
  • Strong familiarity with local Regulatory requirements(as per Bulgarian Medicines Authority etc.) 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

Why Choose Excelya?

At Excelya, we lead with Audacity, act with Care, and move with Energy. We nurture your potential through high-impact projects, give your talents the space to shine, and push boundaries to elevate every patient’s journey. Here, you're not just doing a job—you’re becoming a key part of something bigger.

So, if you're ready to excel with purpose, let’s write the next chapter together.

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Sobre Excelya

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.

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