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Regulatory Affairs Strategic Expert

Regulatory Affairs Strategic Expert

Ceva Santé AnimaleBudapest, HU
18 days ago
Job description

Regulatory Affairs Strategic Expert

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.

Yourmissions : 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

    • Your profile : 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 our website. 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.

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