Associate Director, Global Regulatory Submission Management
Job ID: REQ-10011620
Date: Jul 03, 2024
Location: United Kingdom
Summary
Our Regulatory Operations Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. We are simplifying and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us in evolving the future of Regulatory Operations and to give our patients and their families a brighter future to look forward to. Apply today and welcome to where we thrive together!
The Role
This role offers hybrid working, requiring 3 days per week in person in our White City, London office. Ad-hoc working hours to overlap the US as required. The Associate Director, Global Regulatory Submissions Manager is an expert level position in Regulatory Affairs Operations - accountable for independently managing the delivery of global cross-functional HA submission documentation and format, overseeing, guiding, and directing publishing activities and dispatch of compliant, complex worldwide regulatory submissions in support of NVS global product portfolios.
About the Role
Major accountabilities:
- Manages multiple, large and complex global regulatory submission projects in eCTD and non-eCTD (e.g., NDA/BLA/INDs, MAAs (CP, MRP, Nees), HA AtoQ, Compliance submissions, etc.) efficiently, accurately, and simultaneously.
- Key contributor and decision driver in submission management activities related to acquisitions, partnerships, and divestitures; point of contact for regulatory agency inspections and other miscellaneous regulatory operational activities.
- Provides expert guidance to project teams related to worldwide HA submission structure/format/requirements, submission filing strategy, eCTD document lifecycle management and submission compilation workflows.
- Leads, coaches, and mentors peers and colleagues.
- Develops and authors training materials and leads efforts to implement training to ensure optimal use of templates, processes, and tools critical to regulatory submission activities.
- Expert advisor in evaluation, selection, and implementation of technologies and processes related to submission planning, publishing, assembly, and archiving (as needed).
- Submission Management Expert on key internal initiatives, Health Authority meetings, and various industry forums/conferences, as required.
- Excellent ability to troubleshoot and assess technical/quality issues relating to compilation, validation, and dispatch of global submission outputs with accuracy.
Your Experience:
- Bachelor’s degree in Life Sciences or a relevant discipline; Master’s degree preferred.
- Extensive experience and knowledge of the Regulatory Affairs environment, regulatory submission format, and worldwide HA requirements and publishing principles.
- Extensive knowledge of the drug development process.
- In-depth knowledge of publishing tools (e.g., DXC, eCTD Xpress, Veeva), global submission validation tools, Document Management systems, Toolbox, HA electronic submission gateways, IRIS, CTIS, MS Office tools.
- Strong interpersonal and negotiation skills; excellent communicator and presenter.
- Expert level project management skills and experience leading meetings, cross-functional teams, and driving change.
- Must be able to innovate, analyze, and solve problems effectively, accurately, and independently.
- Fluent in English (both written & oral); additional language an asset.
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?
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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