Registration Manager (d/f/m), Kundl, Tyrol, Austria
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.
Join us as a Founder of our ‘new’ Sandoz!
1500! This is the average number of new submission Regulatory Affairs (Sandoz Small Molecule) does per year.
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.
Please note that we offer a permanent contract for this position.
Your key responsibilities:
Your responsibilities include, but are not limited to:
• 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
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you’ll bring to the role:
Essential:
• Academic degree in life sciences (Chemistry, Biochemistry or equivalent area)
• At least 2 years of experience in Regulatory Affairs (with a focus on knowledge of CMC requirements)
• Develops and presents strategic regulatory options to internal and external stakeholders
• Demonstrates strong leadership skills, establishes (cross-functional) teams/relationships and maintains them
• Very strong communication skills in English
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!
Imagine what you could do here at Sandoz!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is €60,212.18/year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. We are open for part-time and job-sharing models and support flexible and remote working where possible.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool
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Functional Area: Research & Development
Job Type: Full Time
Employment Type: Regular
