Your responsibilities include, but are not limited to:
Achieve the best product registration with commercially attractive labelling in accordance with registration plan
Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance
Ensure compliance with relevant regulations and laws for related CPO activities
Foster and maintain good relations with internal and external stakeholders
Reporting of technical complaints / adverse events / special case
preparation and submission of regulatory dossiers, maintenance of regulatory databases and archives and artwork-related activities.
What you’ll bring to the role:
Completed degree high school diploma
2 years of experience within Regulatory Affairs for Biosimilars
User knowledge of MS Office (Word, Excel, Outlook)
Experience in dealing with databases is an advantage
Good written and spoken German and English skills
Structured and organized way of working
Ability to learn and willingness to develop further
Customer orientation and communication skills
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 € 46.305,00/year (on a full time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications. We support flexible and remote working within Austria where possible.
Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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: Job search | Sandoz