Registration Manager (d/f/m) - Temporary Contract 1.5 years

Job Description

Registration Manager (d/f/m), Kundl, Tyrol, Austria

2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!

Together we will shape the future of Sandoz... are you ready to make a difference?

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 this is a temporary contract limited to 1.5 years.

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

Diversity & Inclusion / EEO

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you'll bring to the role:

Essential:
• Academic degree in life sciences (Chemistry, Biochemistry or equivalent area)
• At least 3 years' 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?

Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we're proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious 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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