Zaduženja
- Administer regulatory software submissions
- Ensure data quality and compliance
- Organize training logistics and access
Neophodno
- University degree in related field
- Fluent English; basic database knowledge
- Familiarity with xEVMPD/IDMP/Art.57
Benefiti
- Private health insurance
- Ongoing professional development
- Language learning platform access
Type of contract: Fix term – Maternity cover
As a Specialist Regulatory Operations, you will be responsible for ensuring data quality and managing regulatory software. If you are passionate about supporting international applications, this opportunity could be the perfect next step in your professional career.
- Take charge of administering and maintaining our cutting-edge software for regulatory submissions, ensuring smooth electronic filings and data submissions to health authorities.
- Provide business support for international applications, including maintaining master data, managing access, and organizing training for teams around the globe.
- Be the gatekeeper of data quality! You'll verify, clean, and manage regulatory data, ensuring it's always compliant with internal standards and external health authorities’ requirements.
- Own the process of master data governance, including generating reports for business users and ensuring scheduled reports are delivered seamlessly.
- Troubleshoot and prioritize issues via a Ticketing system, resolving them independently by following best practice guidelines and Standard Operation Procedures (SOPs).
- Be dedicated to continuous improvement, actively contributing to knowledge-sharing and process enhancements across the Group.
- Play a key role in organizing logistics for training sessions and managing system access for our stakeholders.
- Work closely with our Regulatory Operations Manager, ensuring the timely, accurate, and high-quality execution of all tasks—reflecting the core values of STADA group.
- University degree, preferably in a relevant field (such as Business Administration).
- Fluent English and have a basic understanding of databases (a plus!).
- Reliable, adaptable team player with excellent communication skills, and you thrive in an international setting.
- Driven to grow, learn, and make an impact in the ever-evolving regulatory operations landscape.
- Familiarity with regulatory frameworks such as xEVMPD, IDMP, and Art. 57 would be highly beneficial.
- Private health insurance (with the possibility of preferential use for family members).
- Continuous professional development through specialized education and training.
- A platform for learning 14 foreign languages, including various learning methods and conversational courses.
- Personalized support for the mental health and well-being of employees and their families through the available Kyan Health application.



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Već 65 godina želimo vam - svako dobro - jer znamo da je dobro zdravlje naše najveće bogatstvo. Naša istorija počinje davne 1960. u severnoistočnom delu Srbije. Šest decenija bilo je dovoljno da se od malog vršačkog pogona razvijemo do kompanije koja posluje na tri kontinenta. Danas smo deo globalne STADA porodice kojoj smo se priključili 2006. godine. Zajedno sa matičnom kućom, celokupan pristup poslovanju kao i svoj korporativni identitet gradimo na četiri ključne vrednosti: Agility,…
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