Specialist RGLI

Job Description

Major accountabilities:

• Preparation of regulatory life cycle maintenance submissions - variations, renewals and second wave submissions, Modules 2 to 5 as per defined timelines.
• Evaluates proposed changes and provides on time regulatory input for worldwide regulatory impact.
• Contributes to performance and KPI´s of the team to deliver agreed targets and objectives and supports reporting.
• On time response to HA commitments, and deficiency letters.
• Ensures that the escalation process to next or higher-level management is followed, as applicable.
• Supports in case of rejections investigation.
• Ensures the receipt of proper product transfers from DRCs, RGLIs and BD Regulatory.
• Provides regulatory consultancy as and when requested by STO/ESO.
• Ensures proper data management and completion of all assigned trainings within specified timelines.
• Any other responsibility assigned after training (as applicable).
  
  

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

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