Job Description Summary
The future is ours to shape.
Job Description
3 key systems and about 80 individual solutions! That's how many our application portfolio consists of, contributing to processes for our 1.100 Regulatory Affairs users. In this role, you will be responsible for overseeing the operations within the regulatory application cluster, managing user issues, changes, and trainings.
Sandoz, of which Lek is also a part, 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 and Lek 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 and Lek!
Your key responsibilities:
Your responsibilities include, but not limited to:
- Become an expert on regulatory applications and be able to act as a consultant for those in terms of collection, evaluation and documentation of requirements from requests received throughout solution design and until implementation.
- Enable user accounts, manage issues, assess and drive implementation of changes related to regulatory applications according to defined standards and if necessary in close collaboration with IT.
- Oversee regulatory applications in terms of coordination of all relevant activities relevant for them.
- Actively contribute to regulatory digitalization initiatives.
- Assist Project Leadership team in all project activities in ensuring provision of timely, efficient and high quality project deliverables in the area of Regulatory
- Lead, coordinate or contribute in project work streams as defined throughout the project (e.g. design, migration, testing, deployment).
What you will bring to the role
Essential Requirements:
- Bachelor of applied science in any field or life science Information Management of a comparable degree.
- Good communication in English (verbal and written)
- Knowledge about working and/or managing of GxP environments (including principles for Good Documentation Practices).
- Strong technical and problem solving skills.
- Ability to connect defined business processes with system functionality and present it in understandable manner within the training material and training itself.
Desirable Requirements:
- Experience in the area of Pharmaceutical and Regulatory Affairs.
Employment at the most reputable employer in Slovenia offers Competitive salary, Annual bonus, Flexible working schedule, tailored to your needs, possibility to work from home, Pension scheme, Employee Recognition Scheme, Expanded program for the promotion of health in the field of physical, mental and social well-being (Energized for Life), Unlimited learning and development opportunities.
Possible job locations: Slovenia (Ljubljana)
We offer permanent contract with 6-month of probation period. You are kindly invited to submit your application in English language, including CV, by 13 October 2024.
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!
Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Skills Desired
