Regulatory Affairs Expert
1 day ago
Company Overview:
At GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd., we are committed to helping people with disease and their families through innovative science and collaboration.
About the Role:
We are seeking a highly skilled Regulatory Affairs Expert to join our team. The successful candidate will be responsible for managing manufacturing transfer projects, ensuring compliance with regulatory regulations, and providing strategic regulatory input for cross-functional deliverables.
Key Responsibilities:
- Manage manufacturing transfer projects and represent regulatory affairs in cross-functional teams.
- Ensure maintenance submissions are prepared on time and in compliance with regulatory regulations.
- Provide strategic regulatory input for the preparation of cross-functional deliverables.
- Use regulatory expertise to identify issues, gaps, and tradeoffs to avoid/minimize delays.
- Manage timely response to HA queries and contribute to preparing strong justifications.
- Enter product-specific attributes in compliance database and applicable RIMs.
- Prepare and finalize documents for HA interactions.
- Contribute to non-project related initiatives focused on productivity and continuous improvement.
- Support other associates within Regulatory Affairs by providing training and acting as a Subject Matter Expert.
Requirements:
- 4+ years of knowledge and experience in regulations, guidelines, and regulatory processes.
- Regulatory experience in manufacturing site transfers.
- Experience with regulatory submission and approval processes.
- Ability to work in a global/matrix environment and with cross-functional teams.
- Planning, execution, reporting, regulatory review, compliance, and submission experience.
- Reliable, timely, accurate, and proactive communication.
What We Offer:
- A competitive salary of £60,000 - £80,000 per annum, depending on experience.
- A comprehensive benefits package, including pension scheme, life insurance, and private healthcare.
- The opportunity to work with a leading pharmaceutical company and contribute to groundbreaking research.
- Ongoing training and development opportunities to enhance your skills and career.
- A dynamic and supportive work environment with a diverse team of professionals.
Why Choose Us?
At GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd., we are dedicated to creating a brighter future for people affected by serious diseases. Join us and be part of a community that is passionate about making a difference.
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