Alternance - Chargé(e) D'affaires Réglementaires H/f

Amgen

Paris, France
On-site
Regulatory submissions
Regulatory intelligence
Promotional material evaluation
Participate in registration/labeling activities including review and validation of translations for SmPC, Package Leaflet, and Labeling

Job Summary

  • Participate in registration/labeling activities including review and validation of translations for SmPC, Package Leaflet, and Labeling.
  • Contribute to regulatory intelligence at national, European, and international levels by coordinating local regulatory intelligence.
  • Evaluate promotional and non-promotional documents, including digitalization of materials, and prepare submission forms for the ANSM.

Matching Summary

Participate in registration/labeling activities including review and validation of translations for SmPC, Package Leaflet, and Labeling.

Skills & Requirements

Must-have

  • Regulatory submissions
  • Regulatory intelligence
  • Promotional material evaluation
  • Clinical trial support
  • English language proficiency

Nice-to-have

  • Proactive communication
  • Synthesis skills
  • Professional development focus

Key Requirements

  • Bac+6 internship in Pharmacy with specialization in Regulatory Affairs or Health Law
  • Familiarity with Office Suite

Work Rights

Not specified

Tailored Resume

Cover Letter