Regulatory Affairs Associate (d/w/m) - Part time 50%
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.
Join us as a Founder of our ‘new’ Sandoz!
Your key responsibilities:
1. Life Cycle Management of registrations (new registrations, variations and renewals)
2. Communication with the local health authorities
3. Coordination of regulatory activities with the headquarter
4. Evaluation of registration dossiers
5. Maintenance of databases and registration documents
6. Creation of local (SmPC, leaflet labeling)
7. Change control for artwork creation under consideration of respective timelines
8. Coordination of risk management plan executions on a local level
9. Securing SOP conformity of processes
10. Support with preparation and control of documents for reimbursement submission
11. Regulatory clearance of marketing documents
What you’ll bring to the role:
1. University degree in a relevant field (e.g. pharmacy, chemistry, biology or similar)
2. Previous experience in the pharmaceutical industry (preferably in the area of regulatory affairs)
3. Self-organized, structured way of working, high quality awareness, proven team-player
4. Accuracy is a key element of your personality at work
5. Ability to work in an environment with changing priorities
6. Fluency in German and English
7. Knowledge of Microsoft Office
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 € 58.199.96/year (on a full time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications.
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.
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