Registration Manager - Kundl, Österreich - Novartis

Beschreibung

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates.

This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Global – this is the name of the market for which the registration manager will be preparing regulatory strategies enabling early patient access to affordable medicines.

• Contribute as Development Regulatory Center (DRC) Manager Chemistry, Manufacturing and Controls (CMC) expert to technical project teams during product development
• Ensure alignment across global and local functions with regard to strategy and direction for timely preparation of high-quality CMC documentation to support new regulatory submissions for complex new product developments and/or for a portfolio of new product development projects
• Independently and proactively identify required documentation for submission and coordinate the availability of approved technical source documents in accordance with project timelines
• Write high-quality CMC documentation according to agreed CMC regulatory strategies, while assuring technical congruency and regulatory compliance, to obtain rapid and advantageous registrations of new products world-wide
• Manage/lead DRC related projects or global initiatives