Regulatory Compliance Manager

4 weeks ago


London, Greater London, United Kingdom Novartis Full time

Corporate Responsibility Manager

 

We are seeking an experienced Regulatory Compliance Manager to oversee the delivery and formatting of CSR appendices, ensuring timely submissions to health authorities. This role will drive the implementation of CDGM initiatives, projects, and process improvement activities to enhance clinical document management systems.


The successful candidate will be responsible for efficient management, coordination, and oversight of CSR appendices for assigned studies, meeting electronic publishing requirements, Health Authority guidelines, Good Clinical Practices, and Novartis SOPs. Key responsibilities include:

  • Supporting the implementation of the submission document readiness management strategy for clinical documents and templates.
  • Developing and maintaining submission readiness processes, contributing to or driving initiatives to improve and innovate business and technical aspects of submission readiness activities.
  • Identifying and communicating processing risks/trends/patterns related to CSR appendices, working with key stakeholders to define and implement appropriate remediations.
  • Serving as a Subject Matter Expert on CSR appendices training materials, formal and informal processes, and tracking tools.


This is an excellent opportunity for a highly skilled professional with strong knowledge of clinical document management processes, advanced knowledge of clinical documentation practice guidelines & principles, and experience in authoring, compilation, and formatting of CSR appendices according to ICH E3. Requirements include 5 years in clinical development/clinical operations or similar business area, 2-3 years working experience with document management systems, and good understanding of technical processes and PC environment including Microsoft suite of products. Additionally, experience with project work or project management in a global, cross-functional multicultural and international matrix organization is essential.


We offer a competitive salary range of $120,000-$180,000 per annum, commensurate with experience, as well as benefits such as health insurance, retirement plans, and paid time off. If you are a motivated individual with a passion for regulatory compliance, we encourage you to apply for this exciting opportunity.



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