Process Excellence Manager Regulatory Affairs
Vor 4 Tagen
We are seeking a Regulatory Affairs Process Manager to drive business process creation, review, and continuous improvement. The successful candidate will be responsible for developing and implementing assigned regulatory processes, ensuring organizational readiness and compatibility with associated systems and technology, as well as compliance with global regulatory requirements and Novartis standards.
Responsibilities:- Develop, implement, and continuously improve regulatory processes, including creating procedural documents and establishing KPIs.
- Collaborate with cross-functional teams to ensure process documentation accuracy and consistency.
- Analyze emerging regulations and regulatory guidelines to identify potential impacts on Novartis regulatory processes.
- Support inspections and internal audits as needed.
- Provide expertise in process design, risk management, governance, and compliance.
- Develop and implement plans for transitioning from old to new/revised processes.
- Life Science degree or equivalent experience.
- Strong knowledge of E2E processes, supporting systems, regulations, and business changes.
- Ability to work in a matrix environment and collaborate with subject matter experts.
- Analytic, influencing, and communication skills.
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