Toxicologist

Toxicologist
Quality

About the Job
The Toxicology Specialist is part of Medical Affairs and Pharmacovigilance Operations (MAPO) and is responsible for providing comprehensive toxicology and non-clinical pharmacology support and expertise globally at Xellia.

Main Responsibilities

Provide toxicology and non-clinical pharmacology expertise to Xellia projects, including strategy development, study planning, design, oversight (in vitro and in vivo), data interpretation, and presentationConduct toxicological risk assessments in support of various Xellia development and manufacturing activities, including Health Hazard Evaluations, impurity safety assessments (for drug substances and products), environmental risk assessments, and calculations for Occupational Exposure Limits (OELs) and Permitted Daily Exposure (PDE)Ensure compliance with global regulatory guidelines in all preclinical studies and stay updated on evolving requirements (ICH, EMA, FDA, etc.)Present toxicological findings to internal and external stakeholders, including project teams and senior management, and provide scientific rationale for progression or discontinuation of drug candidatesContribute non-clinical input to regulatory documents (e.g., writing Non-Clinical Overviews and Summaries, preparing toxicology reports for regulatory submissions) for marketing authorization and engage in regulatory agency communicationUse experimental data to assess a drug's toxicological profile and define safety marginsAct as a subject matter expert during regulatory inspections and audits, providing documentation and addressing inquiriesSupport responses to medical inquiries, deficiency letters (clinical and non-clinical), and other activities within the department's scopePursue continuous professional development in toxicology and related fieldsComply with company policies (e.g., purchasing, travel, EHS)Act in alignment with Xellia's behavioral standards at all timesStudy relevant scientific literature to maintain up-to-date knowledgeSupervise staff as part of deputy responsibilities

What We Expect

Minimum Master of Science (or equivalent) in life sciences or veterinary medicineMinimum 5 years of experience in regulatory toxicology within the pharmaceutical industryRegistered toxicologist certification (ERT, DABT, or ATS) is an advantageSolid knowledge of general and regulatory toxicologyGood understanding of drug development processes and non-clinical regulatory requirementsExperience with non-clinical study conduct and oversightExcellent oral and written communication skills both in Hungarian and EnglishTeam player with a pragmatic, solution-oriented mindsetAbility to multitask and work effectively with various stakeholders under tight deadlines

What we offer:

Competitive salary and benefits package, including free access to multiple gyms in Budapest and regular health screeningsOpportunities for continuous learning, growth, and developmentFlexibility with 2 days of home office per weekA supportive team environment with friendly, motivated colleaguesThe stability of an international company with a dynamic, multinational culture

Xellia Pharmaceuticals is the global leader in fermentation-based, non-beta-lactam anti-infectives, supplying Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs) to over 500 pharmaceutical companies across 80 countries.

Recognized by the World Health Organization and the European Union for our critical medicines, we play a vital role in combating severe infections and antimicrobial resistance. Headquartered in Denmark, we operate manufacturing sites in Copenhagen, Denmark; Budapest, Hungary; and Taizhou, China, with R&D and commercial operations in eight additional locations globally. As the only European manufacturer of several key anti-infectives and with a heritage spanning over 120 years, we are driven by purpose and progress.

With more than 1100 employees, our impact starts from within. We offer a workplace where ideas, curiosity, and initiative thrive, and where your role evolves with your ambition. Instead of rigid structures, we provide real responsibility, freedom to explore, and support to grow. Together, we shape not only the future of our company and the development of our people, but also the health of communities worldwide.

Further information about Xellia can be found at:
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