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Urgent! Regulatory affairs Manager (Algeria) Job Opening In Algiers – Now Hiring Danone

Regulatory affairs Manager (Algeria)



Job description

Short Intro and About the Job

Danone MENA recherche un Responsable Affaires Réglementaires pour la Nutrition Spécialisée, basé à Alger

Danone MENA recherche un Responsable Affaires Réglementaires talentueux pour son activité Nutrition Spécialisée au Moyen-Orient et en Afrique du Nord, basé à Alger, Algérie.

Le/la Responsable Affaires Réglementaires jouera un rôle clé en veillant au respect des exigences réglementaires dans plusieurs pays du Golfe et agira en tant qu’interface entre les distributeurs/clients, les sites de fabrication, notamment dans le cadre de nos prochains lancements et expansions opérationnelles.

Ce poste requiert une compréhension approfondie des cadres réglementaires régionaux et la capacité à naviguer efficacement dans des exigences complexes.

Il/elle sera chargé(e) de surveiller les dossiers d’enregistrement (demande et examen des documents, compilation des dossiers, envoi pour soumission) et le contrôle des étiquettes.

Maintenir à jour l’enregistrement de tous les produits de l’entreprise et s’assurer que tous les produits peuvent accéder au marché sans contrainte réglementaire.

Gérer le processus d’étiquetage depuis la création jusqu’à l’approbation finale :

  • Gérer le processus d’enregistrement des nouveaux produits/variations de la planification jusqu’à l’approbation par les autorités gouvernementales, y compris le suivi auprès des distributeurs et points de fourniture concernant la soumission des documents et leur validation.
  • Assister à la pré-planification régionale de l’enregistrement des nouveaux produits en vue des lancements.
  • Surveiller et mettre à jour un fichier Master Data pour chaque pays concernant : les exigences d’étiquetage, les exigences d’enregistrement.
  • Gérer le suivi des enregistrements et le garder à jour (fichier Excel incluant les dates de demande de documents, dates de soumission, commentaires des autorités sanitaires, dates d’enregistrement…)
  • Vérifier les étiquettes selon les lois locales, garantir la conformité et valider pour approbation finale.
  • Examiner le matériel de communication et le valider selon les lois locales avant approbation finale.
  • Assurer le suivi de la certification Halal du processus GMP pour chaque expédition.
  • Maintenir le fichier master data relatif aux exigences d’étiquetage et d’enregistrement par pays :

  • Valider et organiser la documentation requise pour les soumissions réglementaires
  • Maintenir une communication proactive avec les distributeurs pour faciliter la soumission dans les temps des documents réglementaires et garantir la conformité avec les réglementations locales.
  • Gérer et mettre à jour le suivi des enregistrements (fichier Excel) incluant les demandes de documents, dates de soumission, commentaires des autorités sanitaires (HA), et statuts d’enregistrement.
  • Gérer les validations d’étiquettes pour garantir les mises à jour rapides dans le système.
  • About You

    Langues requises :

  • Maîtrise du français et de l’anglais.
  • Expérience :

  • 3 à 5 ans d’expérience dans un poste réglementaire sur le marché pharmaceutique.
  • Formation :

  • Diplôme universitaire en pharmacie, nutrition ou sciences de la vie (préféré, mais non exclusif).
  • Compétences informatiques :

  • Maîtrise de Microsoft Office, en particulier Excel, Word et PowerPoint.
  • Compétences comportementales :

  • Grande attention aux détails
  • Forte éthique et valeurs
  • Excellentes compétences en communication
  • Ouverture d’esprit, esprit collaboratif
  • Capacité à instaurer la confiance
  • Orientation résultats
  • Esprit de remise en question du statu quo
  • Forte capacité de suivi
  • Valeurs Danone :

    Les candidats sont attendus à adhérer aux valeurs fondamentales de Danone : Humanisme, Ouverture, Proximité & Enthousiasme

    Code OMS sur les substituts du lait maternel :

    Nutricia Middle East DMCC (membre du Groupe Danone), actif dans le domaine de la nutrition infantile et jeune enfant, s’engage à respecter des règles spécifiques pour se conformer au Code OMS sur les substituts du lait maternel et à toute réglementation locale applicable.

    About Us, We offer and What's next

    Danone est un leader mondial de l’agroalimentaire, opérant dans trois divisions : Produits Laitiers Frais, Nutrition Spécialisée et Eaux.

    La mission de Danone est d'apporter la santé par l’alimentation au plus grand nombre et nous invitons chacun à rejoindre le mouvement pour un monde plus sain.

    Nous reconnaissons le pouvoir des choix quotidiens pour impacter le monde.

    À chaque repas et boisson, nous votons pour le monde dans lequel nous voulons vivre.

    Nous croyons qu’un corps sain a besoin d’une nourriture saine, et qu’une nourriture saine nécessite une planète saine, c’est tout le sens de notre signature One Planet One Health.

    Nous offrons

    Travailler chez Danone MENA est l’un des meilleurs environnements pour construire une carrière solide grâce à l’apprentissage quotidien, l’autonomisation et la collaboration en équipe dans une culture ouverte.

    Notre culture favorise l’autonomie et l’initiative, où chaque journée peut être une nouvelle aventure – pleine de possibilités et d’opportunités pour votre développement.

    Chez Danone MENA, nous valorisons ce qui fait votre unicité.

    Nous sommes fiers d’être un employeur qui offre l’égalité des chances, où chaque recrutement repose sur les qualifications, le mérite et les besoins de l’entreprise.

    Nous recrutons, employons, formons et promouvons sans distinction de race, couleur, religion, handicap, sexe, origine nationale, âge, caractéristiques génétiques ou tout autre statut protégé.

    Fidèles à nos valeurs d’ouverture et d’humanisme, tous nos collaborateurs s’engagent à interagir avec dignité et respect.

    Short Intro and About the Job

    Danone MENA is looking for a talented Regulatory Affairs Manager for its Specialized Nutrition Business in the Middle East and North Africa region to be based in Algiers, Algeria

  • The Regulatory Affairs Manager will play a crucial role in ensuring compliance with regulatory requirements across multiple Gulf countries, and acts as the interface between distributors/customers, manufacturing sources, particularly in relation to our upcoming launches and operational expansions.

    This position requires a deep understanding of regional regulatory frameworks and the ability to navigate complex requirements efficiently.
  • He or She will Monitor registration files (documents request and review, compilation of files, send to submission) and label control.
  • Maintain the registration of all the companies’ product up to date and ensure that all products can reach the market without any regulatory constraints.
  • Managing the label process starting from creation until final approval:

  • Handle the registration process of new products/variations from planning until approval from the governmental authorities, including following up with distributors and supply points on submission of documents, and documents’ validation · Assist with regional pre-planning of registration of new products in preparation for launches
  • Monitor and update a Master Data file related to each of: Labels requirements per country, Registration requirements per country
  • Manage the registration tracker and keep it up to date (Excel sheet including Dates for documents requests, submission dates, HA comments, registration dates…) review labels as per local laws and ensure compliance and sign off for the final approval review communication material and validate versus local laws before signing off the final approval follow on the Halal certification from the GMP process for each shipment;
  • Maintain the master data file related to labels and registration requirements per country:

  • Validate and organize documentation required for regulatory submissions
  •  Maintain proactive communication with distributors to facilitate timely submission o
  • Regulatory documents and ensure compliance with local regulations.
  • Manage and update the registration tracker (Excel sheet) including document requests
  • Submission dates, Health Authority (HA) comments, and registration statuses.
  • Manage label approvals to ensure timely updates in the system.
  • About You

    Languages required:

    · Fluent in French, English .

    Experience:

    3 to 5 years of Experience in regulatory position in Pharma market.

    Education:

  • Preferably but not limited to: University degree in pharmacy ,Nutrition and Life Science
  • Competency in use of Microsoft Office especially Excel, Word and Power Point
  • Soft Skills :

  • Strong attention to details
  • Strong ethics and values
  • Excellent communicator and communication skills
  • Open minded, collaborative
  • Able to build trust
  • Results driven
  •  Ready to challenge status quo
  • Strong follow
  • Danone Values:

    Candidates are expected to adhere to Danone’s core values: Humanism, Openness, Proximity & Enthusiasm.

    WHO Code of Breast Milk Substitutes:

    Nutricia Middle East DMCC (part of Danone Group) acting in the field of infant and young child nutrition

    is committed to respect specific rules to comply with the WHO Code of Breast Milk Substitutes and any

    related regulations applying locally

    About Us, We offer and What's next

    Danone is a world-leading food company operating in three business divisions: Fresh Dairy Products, Specialized Nutrition, and Waters.
    Danone’s mission is Bringing health through food to as many people as possible, and we want to invite people to join the movement for a healthier world.

    We recognize the power people have in impacting the world through their daily choices.

    Each time we eat and drink, we vote for the world we want to live in.

    We believe a healthy body needs healthy food.

    And healthy food needs a healthy planet and this is what our new signature One Planet One Health embodies.

    We offer
    Working in Danone MENA is one of the best places to build a strong career through everyday learning, empowerment, and team collaboration in an open culture & environment.

    Our culture fosters autonomy and empowerment, where your everyday can be a fresh adventure - full of new possibilities and opportunities for your development.

    Danone MENA doesn’t just welcome what makes you unique, we value it.

    We’re proud to be an equal opportunity employer, where all hires to our team are based on qualifications, merit, and business needs.

    We recruit, employ, train, and promote regardless of race, color, religion, disability, sex, national origin, age, genetic characteristic, or any other protected status.

    Faithful to our values of openness and humanism, all of our employees share in the commitment to engage one another with dignity and respect.


    Required Skill Profession

    Business Operations Specialists



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      Unlock Your Regulatory affairs Potential: Insight & Career Growth Guide


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