Dossier Manager
The success of a company depends on the passionate people we partner with.
Together, let's share our talents.
As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.
We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.
Indeed, Our “Together, Beyond Animal Health” vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.
As part of our “Diversity, Equity and Inclusion” policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.
Your
missions :
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
Your
profile :
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
- Professional experience in regulatory affairs related activities
- Knowledge of regulatory environment, EU and international requirements
- Experience in negotiation with authorities
HOW TO APPLY
Please submit your English Resume through our website. Our Talent acquisition team is looking forward to receiving your application.
