
Director of Process Excellence
5 days ago
Job Title: Regulatory Affairs Process Director
Key Job Responsibilities:
- To drive regulatory process transformation and excellence as a key member of the team, contributing to the development and implementation of E2E regulatory processes transformation roadmap and strategy, enabling increased efficiency, reduced complexity, and high-quality regulatory deliverables.
- To act as a core member of the RA Process Review Committee to secure timely and impactful review, finalization, and assignment of new or revised process documents to relevant roles within RA.
- To lead impact assessments, business process design, ownership, and continuous improvement (including technology and automation needs) for assigned processes and/or process areas.
- To develop and maintain procedural documents, establish KPIs, and work with the Training & Capability team to provide associated functional training.
- To monitor and review emerging regulations and regulatory guidelines, analyze their impact on Novartis regulatory processes, and ensure outcome of the assessment is actioned.
- To lead process changes in case of identified compliance issues resulting from audit/inspection, QI, KPI trending.
- To contribute to inspections and internal audits as Point of Contact for respective processes.
- To provide direct input and expertise in process design, risk management, governance, organizational design, and compliance.
- A degree in Life Science or other University degree with equivalent experience.
- Significant regulatory and drug development experience.
- Extensive knowledge of E2E process, supporting systems, regulations, and business change(s).
- A strong working knowledge of Quality Management System (QMS), SOPs, and compliance.
- The ability to leverage and foster use of systems, technology, and automation to derive efficiency.
- The ability to define and interpret metrics.
- Strategic thinking; process simplification and optimization.
- A strong process authoring/writing capability.
- Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution.
This role requires strong leadership skills, excellent communication and negotiation abilities, and a deep understanding of regulatory processes and compliance.
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