Regulatory Affairs Process Excellence Specialist
1 month ago
Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives. We are seeking key talent to join us and help give people with disease and their families a brighter future to look forward to.
This role offers hybrid working, requiring 3 days per week in our office. In this role, you will be responsible for the development and implementation of regulatory quality processes and procedures, aligning with global RA and other functions.
- 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 identify 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:
- Pharmaceutical industry experience, in Regulatory Affairs.
- Demonstrable experience in working knowledge of SOPs and compliance.
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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