Regulatory Affairs Manager M/F

Ceva Santé Animale; Beaucouzé; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

Une entreprise leader dans la santé animale recherche un RA Manager pour gérer les affaires réglementaires de ses produits vétérinaires. Le poste nécessite une expérience de 5-10 ans dans le secteur, en interaction avec des autorités réglementaires et des parties prenantes. Vous serez responsable de la conformité réglementaire, de l'enregistrement des produits et du conseil à l'entreprise sur les risques réglementaires. Ce poste dynamique offre la possibilité de télétravail dans un environnement international.

Qualifications

• Diplôme en médecine vétérinaire, pharmacologie ou biologie avec formation réglementaire.
• 5-10 ans d'expérience en produits vétérinaires immunologiques.
• Fluent in English; dynamique et capable de relever des défis.

Responsabilités

• Gérer les activités d'affaires réglementaires des produits médicinaux vétérinaires.
• Préparer des dossiers d'enregistrement en collaboration avec plusieurs équipes.
• Conseiller l'entreprise sur les opportunités ou les risques réglementaires.

Connaissances

Gestion des affaires réglementaires

Communication

Gestion des risques

Formation

Diplôme en médecine vétérinaire

Formation en affaires réglementaires

Description du poste

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 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 an RA Manager (M/F).

The role involves addressing local operational issues within a global context and interacting with many individuals within regulatory, business, and logistics groups to meet business unit needs and ensure regulatory compliance.

The RA Manager's primary responsibilities include managing the regulatory affairs activities of Ceva’s veterinary medicinal products, maintaining product and manufacturing site authorizations to ensure business continuity, and monitoring RA compliance with internal and external regulations.

This includes managing product registration activities and manufacturing site regulatory authorizations, in accordance with corporate policies, local regulatory requirements, and strategic directions of the business unit.

More specifically, product registration activities involve:

• Managing the regulatory lifecycle of a group of product registrations,
• Preparing new technical registration files in collaboration with R&D, manufacturing, Quality Control, Quality Assurance, and Marketing teams,
• Submitting dossiers to relevant local authorities and following up on procedures.

The RA Manager also provides guidance and advice related to the registration of the product portfolio, weighing and managing associated business risks. Advising the business on regulatory opportunities or risks is crucial to facilitate growth or prevent losses.

The RA Manager participates in developing and maintaining relationships with regulatory authorities in their areas of responsibility, liaises with internal and external stakeholders, and defends the company's interests in compliance with legal requirements and company principles.

Your profile :

You hold a degree in veterinary medicine, pharmacology, or a master's in biology with additional regulatory affairs training. Ideally, you have 5-10 years of experience in immunological veterinary medicinal products.

You are fluent in English and are a dynamic individual who enjoys challenges and wants to join an international company.

The position is based in Angers, with the possibility of remote work.