Regulatory Affairs Expert

2 weeks ago


London, Greater London, United Kingdom Novartis Full time
About the Role

This is a unique opportunity to leverage your expertise in Regulatory Affairs (RA) and take on the responsibility of creating, reviewing, and updating procedural documents for RA owned processes.

Key Responsibilities
  • Develop clear, concise, and accurate RA owned procedural documents in alignment with respective functions.
  • Collaborate with subject matter experts (SMEs) and stakeholders to gather necessary information and feedback for the document.
  • Prioritize process timelines and requirements and obtain all approvals from impacted Functions and QA.
  • Lead SME teams through the procedural update process and manage necessary steps in applicable systems.
  • Provide strategic recommendations for improving the RA procedural document landscape, identifying opportunities to streamline and simplify it.
  • Efficiently track and report procedural document status.
Your Background
  • Bachelor's degree in life science or related field.
  • Pharmaceutical industry experience, preferably in regulatory affairs with experience in SOP writing.
  • Knowledge of regulatory guidelines and standards e.g. FDA, EMA ICH, etc.
  • Strong interpersonal, communication, and negotiation skills.
  • Able to work independently.
  • Experience working in complex, cross-functional environments.
  • Fluency in English (written and spoken).
Why Novartis?

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

Salary Information

We offer a competitive salary range of £65,000 - £85,000 per annum, depending on experience.



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