Chargé affaires réglementaires procédures zone afrique & internationale h/f

Dans le cadre de la stratégie mondiale de développement et de défense des produits pharmaceutiques de Ceva Santé Animale, le/la Chargé(e) Affaires Réglementaires Procédures Zone internationale travaille en étroite collaboration avec la R&D, les Affaires Réglementaires Dossiers, les fonctions support (Supply, PAO, Industriel, ) et le Marketing.

Rattaché(e) au Responsable Affaires Réglementaires Procédures Pharma au sein de la Direction I&D, il/elle réalise les missions suivantes :
- Vous développez l'Expertise Réglementaire dans l'ensemble des pays de votre zone géographique, et la maintenez à jour selon les évolutions des réglementations locales et internationales.
- En collaboration avec les équipes réglementaires en charge de la rédaction des Parties Qualité, Sécurité et Efficacité, vous définissez et mettez en oeuvre la stratégie réglementaire des dossiers d'AMM dans les pays de votre zone géographique pour les produits pharmaceutiques de Ceva afin d'assurer le respect de la réglementation pour le développement, l'enregistrement et le maintien des AMM.
- Vous assurez la préparation, la communication (aux Franchises et aux Opérations dans les pays) et la coordination des programmes d'enregistrement, de maintien et de défense du portefeuille de produits Pharmaceutiques Ceva en établissant les plannings de soumission, en assurant les relations auprès des équipes Affaires Réglementaires locales, ainsi que des Autorités et en collaborant avec les services internes. Regulatory Affairs Officer, Africa & International Zone

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 :

As part of Ceva Animal Health's global strategy for the development and defense of pharmaceutical products, the International Regulatory Affairs Officer works closely with R&D, Regulatory Affairs, support functions (Supply, DTP, Industrial, etc.) and Marketing.

Reporting to the Head of Regulatory Affairs Procedures Pharma within the I&D Department, he/she performs the following tasks :

You develop regulatory expertise in all countries within your geographical area and keep it up to date in line with changes in local and international regulations.
In collaboration with the regulatory teams responsible for drafting the Quality, Safety, and Efficacy sections, you will define and implement the regulatory strategy for marketing authorization applications in the countries within your geographical area for Ceva's pharmaceutical products to ensure compliance with regulations for the development, registration, and maintenance of marketing authorizations.
You will be responsible for preparing, communicating (to Franchises and Operations in the countries) and coordinating programs for the registration, maintenance and defense of Ceva's pharmaceutical product portfolio by establishing submission schedules, liaising with local Regulatory Affairs teams and Authorities, and collaborating with internal departments.

Your profile :

Degree in Pharmacy or Veterinary Regulatory Affairs or equivalent in the field of Chemistry, Pharmacy and/or Regulatory Affairs, with at least 1 to 5 years' experience in veterinary drug registration, preferably in the Africa/North Africa region.

Technical skills :
- Fluent in written and spoken French and English, as well as scientific language in English.
- Effective negotiation skills with interlocutors of different sizes and types, including authorities.
- Ability to prepare and follow up on registration files.
- Ability to advise and train others in analyzing data from multiple sources to define appropriate regulatory business objectives.
- Ability to make appropriate recommendations on regulatory strategy.
- Ability to interpret the business implications of regulatory decisions in a timely manner.
- Ability to use electronic submission/filing tools in accordance with local requirements.

Softskills :
- Confident communicator and public speaker.
- Able to manage multiple activities at once.
- Able to handle stressful situations with internal and external stakeholders.
- Ability to work independently.
- Ability to work as part of a team and provide support outside of one's area of expertise when needed.
- Ability to work under supervision and provide technical advice.