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Stagiaire Affaires Réglementaires Export H/F – 5/6 mois

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Viatris

8d ago

  • Internship
    Full-time
    Off-cycle Internship
  • Healthcare
  • Lyon
  • Quick Apply

AI generated summary

  • You should have an AR background, initial corporate experience ideally in an AR service, and fluent written and spoken English. Be dynamic, team-oriented, organized, and detail-oriented.
  • You will manage regulatory submissions, ensure compliance, conduct reporting, liaise with partners, analyze requirements, and assist in product launches and tenders.

Requirements

  • De formation AR
  • Première expérience dans le monde de l’entreprise, idéalement au sein d’un service AR
  • Anglais écrit courant et oral opérationnel
  • Dynamique, esprit d'équipe, rigueur et sens de l’organisation.

Responsibilities

  • Réaliser les activités liées à l’enregistrement et au maintien des autorisations de mise sur le marché des pays dont vous avez la charge, dans le respect de la réglementation et des délais impartis.
  • Participer à la préparation des dossiers d’enregistrement, de variation, de réponse aux questions et de renouvellement des produits en charge et en effectuer le suivi
  • Assurer le rôle d’interface auprès des partenaires internes et externes des pays dont vous êtes garant et en assurer la veille réglementaire.
  • Effectuer un reporting régulier de ses activités à sa hiérarchie.
  • Analyser les exigences réglementaires de chacun des pays et organiser la gestion des formalités administratives des dépôts des dossiers (traductions, légalisations, échantillons…).
  • Création ou modification (via les outils informatiques de gestion des changements) des articles de conditionnement spécifiques le cas échéant
  • Participer aux réunions relatives au lancement de produits le cas échéant ainsi qu’aux réunions relatives au Life Cycle Management avec différents services internes (AQ, supply, LCM …)
  • Suivi des dépôts et approbations nationales avec renseignement des tableaux de bord et bases de données internes.
  • Participation à différents appels d’offre : recueil des informations et documents requis pour transmission au service commercial.

FAQs

What is the duration of the internship for the Stagiaire Affaires Réglementaires Export position?

The internship is for a duration of 5 to 6 months.

What are the main responsibilities of the Stagiaire Affaires Réglementaires Export?

The main responsibilities include managing market authorization registrations, preparing registration files, ensuring regulatory compliance, and participating in product launch meetings.

What qualifications are required for this internship?

A background in regulatory affairs, a first experience in a corporate environment ideally within a regulatory affairs department, and proficiency in written and spoken English are required.

Is prior experience in regulatory affairs necessary for this position?

While a first experience in the business world, ideally in a regulatory affairs department, is preferred, it is not an absolute requirement.

What skills are important for the Stagiaire Affaires Réglementaires Export role?

Important skills include being dynamic, having team spirit, attention to detail, and strong organizational skills.

Will I receive training during my internship?

As an intern, you will likely receive guidance and support from your team to help you understand your responsibilities and the regulatory landscape.

What kind of work environment can I expect at Viatris?

Viatris fosters a collaborative culture that supports courage and resilience, aiming to create a positive impact on global healthcare.

Does Viatris promote diversity and inclusion in the workplace?

Yes, Viatris is committed to creating a diverse, inclusive, and authentic workplace.

Are there opportunities to participate in other projects or activities during my internship?

Yes, interns may have the opportunity to participate in various projects, including product launches and regulatory compliance activities.

What is Viatris’s approach to corporate social responsibility?

Viatris focuses on developing responsible and sustainable practices to enhance health outcomes for communities, reflecting its commitment to corporate social responsibility.

We believe in healthcare not as it is, but as it should be

Manufacturing & Electronics
Industry
10,001+
Employees
2020
Founded Year

Mission & Purpose

Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. Our differentiated portfolio includes brands, generics, and complex generics across multiple therapeutic areas. Our product diversity combined with our global scale, local approach and deep understanding of our markets allows for better access to customers and patients in more than 165 countries and territories. From our unique vantage point, we have the ability to touch all of life’s moments from acute conditions to chronic diseases. We put the person at the center of their own unique health journey. Viatris is more than a place to work, it is a place to make an impact in the world. Our culture is performance-driven, highly engaging and inclusive. We support and invest in our colleagues living, learning, growing and achieving on behalf of our mission. Four simple but powerful expectations define The Viatris Way – Own It. Be Real. Stay Agile. Take Pride. Ultimately, we know we are Stronger Together, working collaboratively and relentlessly across our company and with the broader global community, in pursuit of access. Because health matters everywhere.

Benefits

  • Retirement savings plans

  • Paid time off and holidays

  • Remote and flexible work arrangements in most locations