Regulatory Publishing Specialist

Our Regulatory Operations Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. To do this, 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 give our patients and their families a brighter future to look forward to. Apply today and welcome to where we thrive together!

Major Accountabilities:

Accountable for:

• Electronically preparing, publishing, quality reviews, validation, dispatch & archiving activities related to clinical deliverables and global regulatory submissions.

Produce high quality, clinical deliverables, and global submission outputs:

• Per agreed timelines and in compliance with worldwide HA requirements, internal working practices, and guidelines.

Act in a global capacity, and partner with various cross-functional stakeholders:

• Regulatory Affair Managers, Regulatory CMC Managers, Clinical Trial Leads, Nonclinical Managers, Safety and Quality associates.
• Clinical Submission Managers, RA Operations Submission Managers, and a publishing team located in multiple regions (e.g., US, EU, UK, and India).

Support the implementation of new technology, tools, and processes:

• Contribute to ongoing initiatives and training, and help identify continuous improvement opportunities.

Support submission resource planning activities, as required.

Essential Requirements:

• Bachelor's degree in life sciences or 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 (e.g., FDA, ICH, EMA, MENA region, CH, MHRA).
• Strong interpersonal and project management skills, and experience working in a complex, global cross functional organization.
• Highly motivated, organized, and detail-oriented team player.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

Why Novartis?

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. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! 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.