Alternant Affaires Réglementaires
Paris, Île-de-France RegionThe Europe & Canada (EUCAN) Business unit supports Takeda's mission at a regional level and as the leader in rare diseases and specialty care, we champion better health and a brighter future for patients, healthcare providers and our people.
Across the EUCAN BU, patients come first in every decision we make. We develop strategic partnerships which deliver value for society and create a culture within which our people can thrive and reach their full potential.
Our mission is to empower and enable our people to fulfill their potential by embracing diversity and creating a high-performance, collaborative working environment. In the EUCAN region integrity is one of our key values. We put patients, trust and reputation before business and this is one of the main reasons why our people choose to work here.
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Job Description
En soutien de l’équipe Affaires Réglementaires, assurer la conformité des activités de l’entreprise en matière de publicité et d’information et d’AMM suivant la législation en vigueur et les exigences Takeda France, auprès des structures concernées.
Missions:
Rattaché(e) au Responsable Affaires Réglementaires, vous contribuez aux missions suivantes :
Contrôle de la publicité, des outils de réduction des risques, des supports de formation internes,
Validation des articles de conditionnement,
Mise à jour des RCP, notice et mentions légales du portefeuille produit,
Préparation et soumission des demandes de modification d’AMM,
Soutien aux projets transversaux (accès compassionnels, précoces, importations, lancement de produits…)
Mise à jour de procédures
Profil:
Formation de type Pharmacien ou Ingénieur (Master Affaires Réglementaires ou équivalent) Bonne pratique de l'anglais écrit et oral.
Maitrise du Pack Office.
Compétences et qualités requise : Vous êtes rigoureux et disposez d'un esprit d'analyse et de synthèse. Vous appréciez le travail en équipe et faites preuve d'initiative.
Locations
FRA - France - ParisWorker Type
EmployeeWorker Sub-Type
Paid Intern (Fixed Term) (Trainee)Time Type
Full timeSuccess profile
What makes a successful team member within EUCAN at Takeda?
- Agile
- Analytical
- Enthusiastic
- Ambitious
- Collaborative
- Entrepreneurial
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Takeda named Global Top Employer for seventh consecutive year. Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
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About Takeda At Takeda, there is an unwavering commitment to putting patients first, and to creating a workplace that is underpinned by empowerment and focused on diversity, collaboration and steadfast values.
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Europe & Canada Business Unit Takeda in Europe and Canada (EUCAN) is delivering leading innovations in oncology, gastroenterology and rare diseases to provide better health and a brighter future for patients.
Working at Takeda
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Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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