Pharmacien Affaires Réglementaires Cdd (f/h) V&i/hématologie

AstraZeneca

Not specified
European registration procedures
Early access program strategy
Labeling and packaging compliance
AstraZeneca is seeking a Pharmacien Affaires Réglementaires for a fixed-term contract in the area of hematology and vaccines, aimed to cover maternity leave. The ideal candidate should possess a pharmacy degree, additional legal qualifications in health law, and at least two years of relevant experience in the pharmaceutical industry

Job Summary

  • The role involves managing a portfolio of products in Vaccines, Immune Therapies, and Hematology within the Pharmaceutical Department.
  • Responsibilities include submitting European registration dossiers, variations, and renewals while maintaining database accuracy.
  • The candidate will serve as the primary contact for health authorities and manage early access programs for concerned product ranges.

Matching Summary

Match Score: 85

AstraZeneca is seeking a Pharmacien Affaires Réglementaires for a fixed-term contract in the area of hematology and vaccines, aimed to cover maternity leave. The ideal candidate should possess a pharmacy degree, additional legal qualifications in health law, and at least two years of relevant experience in the pharmaceutical industry.

Skills & Requirements

Must-have

  • European registration procedures
  • Early access program strategy
  • Labeling and packaging compliance
  • Market access strategy
  • Regulatory monitoring ANSM EMA

Nice-to-have

  • Autonomous and proactive mindset
  • Strong confidentiality sense
  • Excellent communication skills
  • Team collaboration spirit
  • Synthesis capabilities

Key Requirements

  • PhD Pharmacist (Pharmacien thésé)
  • Master's degree in Health Law or Drug Registration
  • Minimum 2 years experience in pharmaceutical regulatory affairs
  • Fluency in English required

Work Rights

Not specified

Tailored Resume

Cover Letter