Specialist - Regulatory Operations (d/f/m)

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.

You’ll receive: 

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 20 December 2024. 

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! 

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.  

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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