Regulatory Affairs Strategic Expert Budapest

Regulatory Affairs Strategic Expert
Budapest
Budapest, Pest megye

Az „Együtt, az állategészségügyön túl” jövőképünk rámutat arra, hogy az emberek, az állatok, valamint bolygónk egészsége és jóléte teljesen mértékben összefügg egymással. Ez a „One Health” megközelítés, amely mellett a Ceva minden eddiginél jobban elkötelezett.

A "Diverzitás, Egyenlő bánásmód és Befogadás" irányelv részeként a Ceva Sante Animale -nél elkötelezettek vagyunk a megváltozott munkaképességű emberek foglalkoztatására, továbbá, hogy megfelelő körülményeket biztosítsunk az interjúztatás folyamata alatt, hogy mindenki számára egyenlő esélyeket nyújtsunk. Szállás igényléséhez kérjük, lépjen kapcsolatba a Ceva HR csapatval.

ABOUT THE JOB

Ceva-Phylaxia seeks applicants for the full-time position of Regulatory Affairs Strategic Expert in the Regulatory Affairs Team within the Regulatory Affairs Directorate of Ceva-Phylaxia. Phylaxia Campus is one of the flagship sites of the Ceva Animal Health group. The RA Team is driving strategic improvements to elevate regulatory expertise and innovation. The team supports regulatory project excellence, license maintenance, and compliance across the product lifecycle.

WHAT YOU’LL DO

Reporting to the Regulatory Affairs Director, you will lead scientific regulatory assessments, develop robust regulatory strategies for the projects and will proactively search for solutions for technical challenges. You will act as a Regulatory Strategic lead, execute RA pre-project work in their specific domain, support the RA core team in addition to providing mentoring to develop RA colleague expertise while proactively addressing regulatory and technical challenges across the development lifecycle. This position will stay up-to-date on new regulations to anticipate the regulatory impact on innovation and portfolio, and to ensure license maintenance, compliance and product life cycle management guidelines are maintained.

YOUR DAY TO DAY

Define regulatory requirements and provide strategic input during project development with R&D

Lead regulatory projects, recommend strategy, and ensure timely regulatory approvals

Develop and execute end-to-end regulatory strategies, including risk assessments and LCM planning

Manage interactions with health authorities, including technical meetings and pre-submission coordination

Coordinate and oversee dossier preparation, response drafting, and publishing activities

Mentor team members and provide up-to-date regulatory intelligence

YOUR FUTURE AT CEVA

Contribute to the RA Transformation Program to elevate strategic capabilities within the regulatory team

Be involved in high-impact product development and in-licensing projects

Participate in international cross-functional teams and agency engagement activities

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 25 annual vacation days

Lunchtime is more enjoyable as it is part of our working hours

WHAT YOU WILL BRING

University degree in Veterinary Medicine, Pharmacy, Life Sciences or related field. Master's degree in the similar field preferred.

15+ years of experience in regulatory affairs of veterinary biologicals and expert working knowledge of EMA/EU regulations.

Proficiency in English, both written and spoken.

Familiarity with regulatory software tools and dossier publishing platforms.

Required key skills: Strong analytical and problem-solving mindset, excellent communication, mentoring attitude, influencing and negotiating, proactive and collaborative approach.

HOW TO APPLY

Please submit your English Resume through to Apply button. Our Talent acquisition team is looking forward to receiving your application. We hope to receive your application and speak to you about job opportunities shortly.