Bratislava, Bratislava Region
17 hours ago
Regulatory Affairs Specialist

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.


Job Description

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 applicationsWork with global vendors and take ownership of translation review, with some translation work performed directly when neededParticipate actively in brand team meetings for products within the assigned responsibilityPresent product updates, packaging status, pending variations, and expected regulatory decisions to colleagues and leadershipSupport cross-functional colleagues on regulatory topics and day-to-day problem solvingHandle tasks beyond standard regulatory scope, such as coordinating processes for patient access or special import situationsContribute to projects outside routine regulatory work, including AI initiatives Review promotional materials at a basic levelCollaborate closely with Czech colleagues on bilingual packaging and shared processes
Qualifications

The ideal candidate will bring:

Minimum 1–2 years of experience in Regulatory Affairs, or alternatively in PV or QA functionNatural sciences degree qualificationsSound working knowledge of Microsoft Word and ExcelBasic familiarity and curiosity to engage with AI toolsComfortable presenting to small groupsExcellent organization, time management, and planning skillsA positive, proactive, and solution-oriented mindsetStrong problem-solving abilities and good judgment in challenging situationsAttention to detail and a collaborative, team-oriented approachLearning agility and the ability to adapt quicklyBasic knowledge of medical devices regulations would be an advantageFluency 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. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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