Scientific Writer – Regulatory Dossiers

About the role

Ceva-Phylaxia, part of the Ceva Animal Health group, is looking for a full-time Scientific Writer for its Biological Registration Dossier Team in the 10th district of Budapest. The team prepares regulatory dossiers, answers authority inquiries and ensures compliance with regulatory requirements throughout product development and lifecycle management. The position is under a two-year fixed-term contract and reports to the Dossier Team Leader.

Key responsibilities

• Write EU and non-EU marketing authorization dossiers, including quality, safety and efficacy documentation
• Prepare answers to technical questions received from authorities during registration procedures
• Act as regulatory correspondent in project teams, working closely with R&D and industrial functions
• Help define R&D projects so they are regulatory compliant
• Take part in resolving conflicts between regulatory requirements and scientific or technical issues
• Maintain product lifecycle management for selected products, including change control and variations

What we offer

• Annual bonus scheme based on individual and company performance, equivalent to at least one month's salary
• Annual cafeteria equivalent to a 13th month's salary
• Premium private insurance and complimentary sports and fitness opportunities
• School starting support for your family
• Travel costs covered for commuters from outside Budapest
• Discounted meals at the on-site restaurant, free secure parking for drivers and 25 annual vacation days