RA Manager, Procedural Documents

About the Role

This role offers hybrid working, requiring three days per week in our White City, London office. As a Manager Regulatory Affairs Procedural Documents, you will be responsible for creating, reviewing, and updating procedural documents for Regulatory Affairs (RA) owned processes. Your role will ensure compliance with relevant guidelines and regulations, and internal Novartis standards.

Key Accountabilities

• Professionally and consistently write clear, concise, and accurate RA owned procedural documents in alignment with respective functions.
• Coordinate with the subject matter experts (SMEs) and stakeholders to gather the necessary information and feedback for the document.
• Handle process timelines and requirements and obtain all approvals from impacted Functions and QA.
• Lead the subject matter expert teams through the procedural update process and manage necessary steps in the applicable systems.
• Provide strategic recommendations for improving the RA procedural document landscape, identifying opportunities to streamline and simplify it.
• Provide efficient tracking and reporting of the procedural document status.

Your Experience

• Bachelor's degree in life science or related field.
• Pharmaceutical industry experience, preferably in regulatory affairs with experience in SOP writing.
• Knowledge of regulatory guidelines and standards e.g. FDA, EMA ICH, etc.
• Good interpersonal, communication, and negotiation skills.
• Ability to work independently.
• Experience working in a complex, cross-functional environment.
• Fluency in English (written and spoken).

Why Novartis?

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.