Regulatory Affairs Member

🔥 1 minute ago

🇧🇬 Bulgaria – Remote

⏱ Part Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Excelya

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Excelya is a leading global Contract Research Organization (CRO) focused on advancing healthcare through innovative solutions and expert guidance. With a presence in 28 countries, Excelya supports biotech, pharmaceutical, and medical device companies by offering full-service, functional service provider (FSP), and resourcing solutions across a broad spectrum of therapeutic areas. The company's unique business model emphasizes collaboration and flexible services, enabling clients to deliver life-changing therapies effectively.

📋 Description

• 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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