Toxicologist

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 presentation
• Conduct 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 candidates
• Contribute 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 communication
• Use experimental data to assess a drugs toxicological profile and define safety margins
• Act as a subject matter expert during regulatory inspections and audits providing documentation and addressing inquiries
• Support responses to medical inquiries deficiency letters (clinical and non-clinical) and other activities within the departments scope
• Pursue continuous professional development in toxicology and related fields
• Comply with company policies (e.g. purchasing travel EHS)
• Act in alignment with Xellias behavioral standards at all times
• Study relevant scientific literature to maintain up-to-date knowledge
• Supervise staff as part of deputy responsibilities

What We Expect

• Minimum Master of Science (or equivalent) in life sciences or veterinary medicine
• Minimum 5 years of experience in regulatory toxicology within the pharmaceutical industry
• Registered toxicologist certification(ERT DABT or ATS) is an advantage
• Solid knowledge of general and regulatory toxicology
• Good understanding of drug development processes and non-clinical regulatory requirements
• Experience with non-clinical study conduct and oversight
• Excellent oral and written communication skills both in Hungarian and English
• Team player with a pragmatic solution-oriented mindset
• Ability 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 screenings
• Opportunities for continuous learning growth and development
• Flexibility with 2 days of home office per week
• A supportive team environment with friendly motivated colleagues
• The stability of an international company with a dynamic multinational culture

Xellia Pharmaceuticals is a specialty pharmaceutical company and a global leader in providing anti-infective treatments and other critical care therapies for serious and often life-threatening conditions. Xellia has an extensive heritage in developing manufacturing and commercializing anti-infective products.

Headquartered in Copenhagen Denmark and owned by Novo Holdings A/S Xellia Pharmaceuticals has more than 1400 employees globally including state-of-the-art manufacturing sites in China Denmark and Hungary. Our strong market position is built on more than 120 years of pharmaceutical industry experience.

Further information about Xellia can be found at:
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