Regulatory Operations Specialist
1 week ago
At Novartis, our Regulatory Operations Team is guided by a clear purpose: to reimagine medicine and improve people's lives.
About the RoleWe are seeking a skilled Regulatory Operations Specialist to join our team in evolving the future of Regulatory Operations. This role will involve preparing and publishing clinical deliverables and global regulatory submissions electronically, while ensuring quality reviews, validation, and dispatch activities meet worldwide Health Authority (HA) requirements.
The successful candidate will produce high-quality clinical deliverables and global submission outputs within agreed timelines, adhering to worldwide HA requirements, internal working practices, and guidelines.
Key Responsibilities- Prepare and publish clinical deliverables and global regulatory submissions electronically.
- Ensure quality reviews, validation, and dispatch activities meet worldwide HA requirements.
- Produce high-quality clinical deliverables and global submission outputs within agreed timelines.
- Bachelor's degree in life sciences or a relevant discipline.
- Fluency in English.
- Clinical Report and Global Submission dossier publishing/compilation experience in the pharmaceutical or related industry.
- Experience with electronic clinical document publishing standards/formats, electronic and global regulatory submission publishing standards/formats (e.g., eCTD, EU CTR).
- Working 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.
- Familiarity with global Clinical and Regulatory HA requirements.
- Strong interpersonal and project management skills, and experience working in a complex, global cross-functional organization.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Our purpose is to reimagine medicine to improve and extend people's lives, and our vision is to become the most valued and trusted medicines company in the world.
Salary$83,000 - $110,000 per year, depending on location and experience.
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