Job Description

Regulatory Affairs Manager M/F 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, contributing 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. 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 Health 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: In order to reinforce our Global RA Team, we are looking for a RA Manager M/F. The role involves significant complexity in addressing local operational issues globally and interacting with many individuals within the regulatory, business, and logistic groups to meet business unit needs and regulatory compliance. The RAM's primary task is to manage the Regulatory Affairs (RA) activities of Ceva’s veterinary medicinal products, maintain product and manufacturing site authorizations, ensure business continuity, and monitor RA compliance against internal and external regulations and requirements. This includes the management of product registration activities and manufacturing site regulatory authorizations, in accordance with corporate policies, local regulatory requirements, and the strategic direction of the business unit under your responsibility. More specifically, product registration activities relate to: The regulatory life cycle management of a group of product registrations, The preparation of the new technical registration files, in collaboration with R&D, manufacturing, Quality Control, Quality Assurance, and Marketing teams, The submission of dossiers to the relevant local authorities and the follow-up of the corresponding procedures. In addition, the RAM has controlling, guiding, and advising tasks in activities that are directly or indirectly related to the registration of its products portfolio. Properly weighing and managing the associated business risks is crucial. The RAM advises the business on any new regulatory opportunities or risks arising in the RA environment to allow the business to realize growth opportunities or avoid losses. The RAM participates in developing proactively and maintaining relations with the authorities responsible for regulatory affairs in the countries of their areas of responsibility, has contact with stakeholders inside and outside the company, and defends the interests of the company in compliance with the requirements of the law and legislation and the business principles of the company. Your profile: You have a degree in veterinary medicine or pharmacology or a master's degree in biology with additional training in regulatory affairs. Ideally, you will already have experience (5-10 years) in the field of immunological veterinary medicinal products. You are fluent in English. You are a dynamic person who likes challenges and would like to join an international company. The position will be based in Angers, with the possibility of remote work. #J-18808-Ljbffr CEVA Logistics

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