Senior Global Regulatory Program Manager

326429BR
Sep 22, 2021
Switzerland

Job Description

26 major approvals. 13 major submissions. 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease conditionals with unmet needs.

We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease conditions with unmet needs.

We are expanding our global team and encourage you to consider a career in Regulatory Affairs at Novartis. Working collaboratively and interactively thanks to our technology, we have been as connected as ever—OneRA as we call it. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine.

This role will support the Immunology, Hepatology, and Immunology portfolio specifically to support a marketed dermatology product. You will be able to contribute efforts towards new registrations, new indication line extensions, Risk Management Plan and Core labeling updates, and responses to Health Authority requests globally.
Your responsibilities will include, but are not limited to:

• Provide input into regulatory strategies and take responsibility for their subsequent implementation under limited supervision
• Manage operational activities for assigned projects and regions in accordance with applicable regulatory standards and within appropriate timeframes
• Represent Regulatory Affairs and lead sub-teams and/or cross-functional teams as required
• Lead or coordinate Health Authority meetings in assigned region(s)
• Contribute to the development of global and local labelling and review of promotional and non-promotional material in assigned region(s)
• Contribute to regulatory excellence by finding opportunities, mitigating risks and supporting continuous optimization and simplification
• Handle internal systems and tools that are needed to assess compliance

Minimum Requirements

Global Drug Development
REG AFFAIRS GDD
Switzerland
Basel
Research & Development
Full Time
Regular
No
326429BR

Senior Global Regulatory Program Manager

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