Regulatory Policy Manager

18 hours ago


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

We are seeking a highly skilled Regulatory Policy Manager to join our team at Novartis Farmacéutica. This is an exciting opportunity for someone who wants to make a real difference in the pharmaceutical industry.

About the Role

This role offers hybrid working, requiring 3 days per week in our office. As a Regulatory Policy Manager, you will be responsible for the development and implementation of regulatory quality processes and procedures, aligning with global RA and other functions. You will also support the implementation of initiatives within RA to support a quality system.

Key Responsibilities
  • Support quality and consistency of RA regulatory compliance activities in assigned region through implementation of new processes, policies, metrics and appropriate training, and ensuring data compliance in the global RIM system.
  • Partner with Region Head, Sub-region Heads, and Subject Matter Experts from assigned region to implement and track training for policies, processes and procedures.
  • Participate in cross-functional process improvement projects to represent the function; help to identifying resources from the function to support cross-functional projects.
  • Support the preparation of the RA organization for internal global audits including CAPA management, collaborating with QA to prepare RA/ Country Organisations for external inspections at HQ including CAPA management.
Requirements

To be successful in this role, you will need:

  • Pharmaceutical industry experience, in Regulatory Affairs.
  • Demonstrable experience in working knowledge of SOPs and compliance.
What We Offer

We offer a competitive salary range of £60,000 - £80,000 per annum, depending on experience, plus benefits including hybrid working, professional development opportunities, and a comprehensive pension scheme.



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