Krka d.d. Novo mesto ·
Novo Mesto, Slovenia · Onsite · €3,500 - €5,500/year
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· Posted 7 hours ago
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Position Overview
Location:
Novo Mesto, Slovenia
Compensation:€3,500 - €5,500/year
Position:Mid
Type:Job
Remote:
No
Posted:
Deadline:
May 19, 2026
Job Description
Krka d.d., one of the world's leading generic pharmaceutical companies headquartered in Novo Mesto, is seeking a Legal Counsel for our Pharma & Life Sciences legal team. Krka operates in over 70 countries and is listed on the Ljubljana Stock Exchange (LJSE). You will provide legal support for pharmaceutical regulatory matters, intellectual property, commercial contracts, and compliance across our global operations.
The role involves working with the Zakon o zdravilih (ZZdr-2, Medicinal Products Act), Zakon o medicinskih pripomočkih (ZMedPri, Medical Devices Act), and EU pharmaceutical regulations. You will advise on product marketing authorizations with the Javna agencija RS za zdravila in medicinske pripomočke (JAZMP, Medicines Agency), patent challenges, and data exclusivity matters critical to Krka's generic pharma business model.
Responsibilities
Advise on pharmaceutical regulatory compliance, including marketing authorization applications to JAZMP and EMA. Support patent challenge strategies and Paragraph IV-type litigation for generic product launches. Draft and negotiate licensing agreements, supply agreements, and distribution contracts for pharmaceutical products. Advise on pharmacovigilance obligations, clinical trial regulations, and EU GMP compliance. Monitor EU pharmaceutical legislation reform, including the revision of the general pharmaceutical legislation.
Requirements
Magister prava or equivalent law degree. 3-6 years of experience in pharmaceutical law, IP, or life sciences regulation. Knowledge of ZZdr-2 (Medicinal Products Act) and EU pharmaceutical legislation. Experience with patent litigation, SPC matters, or Bolar exemption applications is an advantage. Fluent in Slovenian and English.
Perks & Benefits
Legal career opportunities, Professional development, Competitive compensation, Health benefits, Retirement planning