Pharmaceutical Affairs Manager

Il y a 2 mois


Paris, Île-de-France Ultragenyx Pharmaceutical Temps plein
Job Summary

We are seeking a highly skilled Pharmaceutical Affairs Manager/Deputy Responsible Pharmacist to join our team in France. This role will be responsible for managing the quality system and ensuring compliance with applicable pharmaceutical regulations for the French and Benelux cluster.

Key Responsibilities
  • Manage and maintain the Quality System for the Cluster
  • Ensure compliance of promotional activities to applicable standards
  • Define, implement, and monitor audits plan and monitoring of subcontractors involved in pharmaceutical activities
  • Ensure readiness for Inspections by competent authorities or audits
  • Process and track deviations, change controls, risk assessments, CAPAs, recalls, and product returns
  • Review packaging materials, promotional, and non-promotional materials
  • Coordinate initial and continuous training for employees
  • Act as a backup for additional responsibilities in the Pharmaceutical Affairs department
Requirements
  • Pharmacist diploma with fluent French and English language skills
  • Qualification as Deputy Responsible Pharmacist and at least 2 years' experience in that role
  • 5-10 years' experience in Quality Assurance
  • 6-12 months experience in Pharmacovigilance and batches follow-up
  • Knowledge of GxP's, with a high focus on French and European regulations, GMP, GDP, and GVP
What We Offer

As a full-time employee, you will enjoy a range of benefits, including generous vacation time, volunteer days, long-term incentive plans, employee wellbeing benefits, fitness reimbursement, tuition sponsoring, and professional development plans.


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