Summary

Role essential for efficient and effective national publishing operations for Marketing Authorisation submissions; reporting of regulatory status in the relevant UK RA Quality Management systems and supporting proactive compliance to key RA procedures with the ability to demonstrate this when required and particularly when called upon at Health Authority inspections and internal audits.

About the Role

Major accountabilities:

• Co-ordinate UK RA publishing operations to ensure effective management of workload within the UK RA Compliance Team

• Drive the development and implementation of end-to-end best practice relating to country publishing activities to ensure the efficient transmission of technically high-quality submissions are consistently made to UK HA

• Support onboarding and act as mentor of UK Regulatory Publishing and Compliance Associates

• UK Regulatory Information Management (RIM) Subject Matter Expert, ensuring UK data compliance in the global RIM system

• Actively representing UK RA in the Global RA Process Improvement and Excellence Network

• Support the preparation and involvement of UK RA in internal global audits and external inspections, including CAPA management

• Support project management and implementation of pan-portfolio regulatory initiatives to ensure efficient and compliant outcome to ensure business continuity

• Support Regulatory Compliance and Process Lead to address potential quality issues and emerging compliance concerns and recommend solutions, providing backup support, as needed with quality incidents/deviations in the appropriate system

• Dependent on individual aptitude, but would expect a minimum of 2-3 years' experience of a broad range of regulatory work in the ethical pharmaceutical industry

• English.