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Regulatory Affairs Project Lead

Il y a 2 mois

Paris, France NonStop Consulting Temps plein
Regulatory Affairs Project Lead

À propos de l'entreprise :

Rejoignez une entreprise innovante et internationale, leader sur son secteur. Engagée dans l'amélioration de la vie des patients à travers le monde, cette société recherche un Responsable Senior Affaires Réglementaires pour l'une de ses divisions.

Le poste est basé en Normandie ou en région Parisienne, mais demandera des déplacements chaque semaines en Normandie, avec la possibilité de télétravailler.

Vos missions :

  • Élaborer et mettre en œuvre des stratégies réglementaires pour une gamme de leurs produits,
  • Gérer les soumissions et maintenir les dossiers réglementaires (DMF) auprès des autorités internationales.
  • Assurer la conformité des produits avec les normes ISO, FDA et autres réglementations en vigueur,
  • Encadrer et animer une équipe dédiée (2 personnes), en priorisant les activités réglementaires,
  • Assurer une veille active sur les évolutions réglementaires et collaborer avec les équipes internes.

Profil recherché :

  • Diplôme en sciences de la vie, pharmacie, ou ingénierie biomédicale.
  • Minimum 7 ans d'expérience en Affaires Réglementaires Pharmaceutiques,
  • Expérience avérée en rédaction et enregistrement (DMF) sur le marché Américain (FDA),
  • Expérience avérée en CMC (Module 3),
  • Un très bon niveau d'anglais écrit comme oral,
  • Expérience en management d'équipe (vous superviserez 2 personnes),
  • La possibilité de vous rendre en Normandie deux fois par semaine environ.


Desired Skills and Experience

Affaires Réglementaires
Regulatory Affairs
FDA / US
CMC / Module 3