Regulatory Affairs Operations Specialist
Vor 6 Tagen
This position is responsible for the development and implementation of assigned regulatory processes, ensuring organizational readiness and compatibility with associated systems and technology, as well as compliance with global regulatory requirements and Novartis standards.
Key Responsibilities:- Drive business process creation, review by Process Review Committee (or equivalent), and continuous improvement, including system, technology, and automation needs to improve process performance. This includes developing, authoring/writing procedural documents, establishing KPIs, and working with the Training & Capability team to provide functional training.
- Actively shepherd process documents through preparation, self-author/write or provide guidance to authors on content with respect to the process.
- In partnership with International/Regions and Policy, monitor and review emerging regulations and regulatory guidelines, analyzing their impact on Novartis regulatory processes.
- Contribute to inspections and internal audits as applicable.
- Provide direct input and expertise in process design, risk management, governance, organizational design, and compliance.
- Pressure-test and risk-mitigate plans for transition from old to new/revised processes.
- Ensure high connectivity, alignment, transparency, and collaboration with Subject Matter Experts across RA and other Development and corporate functions and departments, as required.
- In partnership with Systems teams, incorporate technology portfolio deliverables into an integrated transformation roadmap and non-drug development projects bearing on broader transformation.
- Contribute to learning/training strategy for regulatory capability building, functional learning, and learning technology.
Evaluate and maintain meticulous version control and accessibility of quality documents (e.g., SOP, WP, BPG) adhering to industry standards.
SOP operational management: Ensure procedure documents are properly created, updated, and uploaded in relevant systems.
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