Dossier Manager

ABOUT THE JOB Ceva-Phylaxia seeks applicants for the full-time position of Scientific Writer / Dossier Manager in the Biological Registration Dossier Team within the Biological Registration Directorate of Ceva’s Phylaxia Campus in Budapest’s 10th district. The Phylaxia Campus is one of the flagship sites of Ceva Animal Health group. The Biological Registration Dossier Team is responsible for preparing regulatory dossiers, responding to authority inquiries, and ensuring compliance with regulatory requirements throughout product development and lifecycle management. They collaborate closely with R D, industrial functions, and project teams to address scientific and technical challenges. WHAT YOU’LL DO Reporting to the Dossier Team Leader, you will prepare and manage regulatory documentation, support marketing authorization processes, respond to authority inquiries, and ensure compliance with regulatory requirements throughout the product lifecycle. YOUR DAY TO DAY Provide regulatory guidance in relation to new product development when needed Review documentation intended for regulatory submissions to ensure relevant regulatory requirements are met Support in defining R D project content so they are regulatory compliant Participate in the problem-solving process in case of conflict between regulatory requirements and scientific/technical issues Write dossiers or part of dossiers (quality, safety and efficacy documentation for marketing authorization applications) for EU and for areas outside EU Prepare answers for technical questions received from authorities during registration procedures Maintain product life cycle management for selected products (participation in change control processes, write variations) Be member of project teams as the regulatory correspondent, work closely with development and industrial functions WHY CEVA-PHYLAXIA? Together, our passionate people drive innovative health solutions for all animals, contributing to the future of our diverse planet. We dedicate our work to protect animal welfare every day We offer stable employment in a resilient industry Our business has been growing exponentially We offer comprehensive training opportunities You can join a dynamically growing team of professionals We provide great benefits focusing on your commitment and well-being COMPENSATION We acknowledge and value your performance with several benefits and bonuses in addition to your salary. We also believe in keeping our remuneration competitive and increasing our salaries annually. We offer an exceptional annual cafeteria equivalent to a 13th month salary You are eligible for an annual bonus scheme based on both individual and company performance, equivalent to a minimum of an additional month’s salary We prioritize your health with a premium private insurance package We support your health with complimentary sports and fitness opportunities We provide school starting support to assist your family If you commute from outside of Budapest, we will cover your travel Enjoy a wide selection of breakfast and lunch options at discounted prices in our on-site restaurant We offer free and secure parking for employees who commute by car Regardless of age, all employees are entitled to at least 25 annual vacation days Lunchtime is more enjoyable as it is part of our working hours