Regulatory Affairs Manager (f/m/d)

Job Description

Regulatory Affairs Manager (f/m/d), Kundl/Tirol, 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?

Your key responsibilities:
• Regulatory evaluation and critical assessment of suitability of regulatory documentation and approaches of external suppliers of active ingredients in regard to nitrosamines and mutagenic impurities in line with ICH M7 guideline and other applicable regulations.
• Actively monitoring of scientific literature and new guidelines in the regulatory field.
• Regulatory evaluation of change requests
• Preparation, submission and maintenance of high-quality registration documents for active ingredients

Diversity & Inclusion / EEO

Novartis is 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:
• Minimum of 3 years of experience in pharmaceutical or chemical industry in a similar role
• Bachelor or Masters degree in natural science
• Broad knowledge of regulatory guidelines
• Good knowledge of relevant software tools

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 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.

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 Novartis and our career opportunities, join the Sandoz Network here: https://talentnetwork.novartis.com/sandoztalentpool