Dossier Manager

Ceva-Phylaxia Zrt.

Standszám:

A9

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

WHAT YOU WILL BRING

University degree as Veterinarian, Biologist, Bio or Chemical-engineer, Microbiologist or in related areas
Excellent communication and organizational skills to build and maintain good interpersonal relationship
Ability to analyse issues objectively and strategically
Ability to work as part of multidisciplinary teams and on several projects simultaneously
Detail oriented attitude, excellent problem-solving capabilities
Stable computer skills
Fluent verbal and written English is a must

ADVANTAGES