Regulatory Affairs Specialist

Due to the upcoming retirement of our colleague we are looking for a Regulatory Affairs professional to join our regulatory affairs function to be based in Bratislava. This role is a key part of a matrix organization working closely with colleagues across commercial market access medical Pharmacovigilance and Quality assurance in Slovakia.

In this role you will:

• Manage regulatory activities for assigned products including registrations and submission applications
• Work with global vendors and take ownership of translation review with some translation work performed directly when needed
• Participate actively in brand team meetings for products within the assigned responsibility
• Present product updates packaging status pending variations and expected regulatory decisions to colleagues and leadership
• Support cross-functional colleagues on regulatory topics and day-to-day problem solving
• Handle tasks beyond standard regulatory scope such as coordinating processes for patient access or special import situations
• Contribute to projects outside routine regulatory work including AI initiatives 
• Review promotional materials at a basic level
• Collaborate closely with Czech colleagues on bilingual packaging and shared processes

Qualifications :

The ideal candidate will bring:

• Minimum 12 years of experience in Regulatory Affairs or alternatively in PV or QA function
• Natural sciences degree qualifications
• Sound working knowledge of Microsoft Word and Excel
• Basic familiarity and curiosity to engage with AI tools
• Comfortable presenting to small groups
• Excellent organization time management and planning skills
• A positive proactive and solution-oriented mindset
• Strong problem-solving abilities and good judgment in challenging situations
• Attention to detail and a collaborative team-oriented approach
• Learning agility and the ability to adapt quickly
• Basic knowledge of medical devices regulations would be an advantage
• Fluency in Slovak a very strong understanding of Slovak grammar and a strong command of English.
• Residence in Bratislava

Additional Information :

This is an excellent opportunity for someone who wants to grow in a highly collaborative regulatory environment with broad exposure to cross-functional work operational problem solving and strategic brand team support. You will play an important role in ensuring that products are correctly registered communicated and supported throughout their lifecycle.

If you are a motivated regulatory professional with strong communication skills and a can-do attitude we would love to hear from you.

This is an office-based position in Bratislava. 

Applications will be assessed ongoing please apply at your earliest convenience.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time