Regulatory Affairs Process Excellence Manager

2 weeks ago


London, Greater London, United Kingdom Novartis Farmacéutica Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Process Excellence Manager to join our team at Novartis Farmacéutica. As a key member of our Development Team, you will be responsible for the development and implementation of regulatory quality processes and procedures.

Key Responsibilities
  • Support the quality and consistency of regulatory compliance activities in assigned regions through the implementation of new processes, policies, metrics, and training.
  • Partner with regional leaders and subject matter experts to implement and track training for policies, processes, and procedures.
  • Participate in cross-functional process improvement projects to represent the function and identify resources to support cross-functional projects.
  • Support the preparation of the RA organization for internal global audits, including CAPA management, and collaborate with QA to prepare RA/Country Organizations for external inspections.
  • Work with the Director of RA Process Excellence to address potential quality issues and emerging compliance concerns and recommend solutions.
Requirements
  • Pharmaceutical industry experience in Regulatory Affairs.
  • Demonstrable experience in working knowledge of SOPs and compliance.
Commitment to Diversity & Inclusion

Novartis Farmacéutica is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.



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