THE FRENCH LEADER OF THE DATA RECRUITS.

Joining Umanis is to participate in a formidable adventure, that of a French company in continuous growth, recognized for its capacity for innovation and its dynamism.

Umanis is more than 2700 enthusiasts of new technologies who share the same values as excellence, responsibility, respect and conviviality.

Umanis, it is a community with an average age of 35 years that intervenes in advanced engineering on the strategic projects of the largest customers of order or on behalf of companies for whom data is transformation vector.

Umanis, it is a management and an organization closest to its collaborators to accompany you in your career. Training, certifications, MOOC, CPEC; We are committed to making you evolve continuously.

The Regulatory Affairs Officer carries out all activities related to the registration and maintenance of marketing authorizations in compliance with the regulations.

He is in contact with the national and international subsidiaries, the business managers of the ranges and the health authorities

YOUR MISSIONS :

Au sein d'une équipe à taille humaine vous travaillerez sur les activités réglementaires d'un grand laboratoire pharmaceutique, vos principales missions seront :

  • Rédaction et mise à jour des dossiers réglementaires : Q&A, module 3, PQVAR, CPID, PMF
  • Contribution à la qualité des dossiers
  • Participation à l'activité de relecture avec les opérations industrielles et le service CMC
  • Planification de l'activité CMC
  • Coordination des dossiers réglementaires CMC : finalisation des dossiers, envois, archivage, reporting des activités
  • Rédaction de modes opératoires et participation aux mises à jour des procédures

REQUIRED COMPETENCIES:

Data management : collect/operation/interpretation (Confirmed), Editorial skills (Confirmed), English (Confirmed), Monitoring, analysis and document management (Intermediate), Regulatory and contractual management (Intermediate), Specific knowledge (Intermediate)

In 2018, Umanis recruited 900 new talents throughout the French territory. What if it was you?


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