Regulatory Affairs Expert
2 weeks ago
This is a unique opportunity to leverage your expertise in Regulatory Affairs (RA) and take on the responsibility of creating, reviewing, and updating procedural documents for RA owned processes.
Key Responsibilities- Develop clear, concise, and accurate RA owned procedural documents in alignment with respective functions.
- Collaborate with subject matter experts (SMEs) and stakeholders to gather necessary information and feedback for the document.
- Prioritize process timelines and requirements and obtain all approvals from impacted Functions and QA.
- Lead SME teams through the procedural update process and manage necessary steps in applicable systems.
- Provide strategic recommendations for improving the RA procedural document landscape, identifying opportunities to streamline and simplify it.
- Efficiently track and report procedural document status.
- 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.
- Strong interpersonal, communication, and negotiation skills.
- Able to work independently.
- Experience working in complex, cross-functional environments.
- Fluency in English (written and spoken).
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Salary InformationWe offer a competitive salary range of £65,000 - £85,000 per annum, depending on experience.
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