Regulatory Affairs Writer (FR/EN) M/V/X

Description de l'entreprise

The client is a leading pharmaceutical company known for its structured approach and high standards in regulatory compliance. They offer a dynamic environment with opportunities to grow in Regulatory Affairs.

Description de la fonction

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  Draft and compile regulatory submission dossiers for marketing authorization (MA) of pharmaceutical products.
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  Ensure scientific and regulatory compliance of all documents according to legal requirements and industry standards.
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  Collaborate with scientific and regulatory teams to gather necessary information.
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  Ensure that each dossier is complete, accurate, and tailored to the targeted markets.

Profil

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  Education: Bachelor's or Master's degree in Regulatory Affairs, Pharmacy, or Biology.
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  Experience: Relevant internship in the pharmaceutical sector or in regulatory dossier preparation.
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  Language Skills: Proficient in English (minimum B2), used on a daily basis.
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  Key Competencies: Detail-oriented, rigorous, with strong scientific and regulatory understanding.

Compétences linguistiques

• Français (atout)

  • Comprendre : Expérimenté - (C1)
  • Écrire : Expérimenté - (C1)
  • Lire : Expérimenté - (C1)
  • Parler : Expérimenté - (C1)

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