| || Position Purpose
Globally responsible for oversight of Regulatory Compliance within Regulatory Affairs (RA) and across functions defined by critical control points for processes and procedures. Perform self- assessments in RA and process interfaces and thereby ensuring identification and resolution of compliance gaps and issues on an on-going basis. Support RA for internal audits and Health Authority inspections. Support implementation of effective and efficient processes that fulfill regulatory requirements and expectations in a sustainable way for the global Novartis portfolio of products. Support submission readiness activities in conjunction with the Clinical Quality Assurance team.
1. Give input to and support the global RA QA Compliance strategy 2. Responsible for a robust compliance monitoring system to ensure RA regulatory compliance on an on-going basis; provides adequate tracking and oversight to any regulatory inspection commitments and ensures their timely closure. 3. Support RA and provide guidance to create relevant remedial and improvement actions for CAPA plans from audit findings, and responsible for follow-up of audit CAPAs to ensure timely closure. 4. Support regulatory risk management through identification, assessment, mitigation and communication of any potential regulatory compliance risks. 5. Perform self-assessments in RA; ensure review and approval of proposed CAPA activities for their effectiveness and timely closure. 6. Oversee that regulatory processes and procedures at the in global RA meet regulatory and company expectations and are part of the on-going monitoring processes. 7. Support a compliance and quality culture within RA through effective cross- functional team work and open communication. 8. Ensure timely investigation and tracking of RA HQ relevant deviations and incidents in collaboration with RA PIE. Ensures review and approval of proposed CAPA activities, and their timely closure. 9. Support implementation of new regulatory requirements by analyzing their impact on the company’s on-going compliance. 10. Escalate compliance status and potential compliance risks, as necessary, to DRA QA Management. 11. Work effectively within the RA QA and Development Quality and build a strong working relationship with RA and other relevant line functions 12. Support critical quality improvement projects
Key Performance Indicator
1. Regulatory processes and systems are systematically subject to self-assessment for potential compliance risks and input to risk mitigation strategies given. 2. RA process gaps are identified and communicated to Compliance and Risk Management Head and Global Head Compliance and Regulatory Affairs Quality as needed. 3. Effective communication between all global and local functions involved in the RA processes and systems. 4. Robust Key Quality indicators are defined together with RA, implemented and continuously monitored and reported; results are regularly assessed for continuous improvement opportunities. 5. Demonstrated cross-functional teamwork and leadership capability. 6. Open communication on a continuous basis. 7. Demonstrated customer focus. 8. Current knowledge on global regulatory guidelines and legal requirements as well as company Quality systems.