Compliance Project Lead

3 weeks ago

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

We are seeking a highly skilled Compliance Project Lead - Global Labelling to join our team at Novartis. As a key member of our organization, you will be responsible for ensuring compliance with global labelling regulations and standards.

Key Responsibilities
  • Track and monitor the global implementation of safety-related product information changes, including routine interaction with cross-functional teams and regulatory associates.
  • Provide compliance reporting for global and local regulatory milestones of the Novartis safety label change process.
  • Support root cause analysis for any delays or non-compliance, and provide input for process improvements.
  • Support internal Pharmacovigilance (PV) CO audits, and interact with Country (CO) and Regional Regulatory Associates to ensure timely and current safety label change (SLC) compliance data and reports are provided.
  • Support local and global PV inspections through preparation of requested SLC data and reports as required.
  • Support the evolution and maintenance of the Novartis safety label change tracking tool (SALTO) and related projects as a SALTO Super User.
  • Provide input for process improvements, training manuals and materials, IT labelling projects, and user testing.
  • Support development of Novartis systems and company projects.
Requirements
  • Bachelor's degree required with relevant regulatory and/or technical experience gained in the pharmaceutical industry.
  • Knowledge of Regulatory Affairs, specifically labelling regulations globally, labelling submission business processes, and related tools.
  • Proven knowledge of data analysis and reporting, excellent verbal and written communication skills, technical/IT skills, and proven ability to be innovative and a creative problem solver with quality and compliance approach.
  • Fluency in English as a business language required.
About Novartis

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

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