Specialist Regulatory Operations

Hemofarm AD is a member of the STADA group, one of the world's largest generic pharmaceutical companies, which successfully operates in the markets of Serbia and the Western Balkans. Hemofarm produces high-quality pharmaceutical products within the leading pharmacotherapeutic groups, respecting key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA.

 

Specialist Regulatory Operations

Location: Beograd/Vršac

 

About the job

We are on the lookout for a Specialist Regulatory Operations who is passionate about driving innovation, ensuring data quality, and contributing to a team that’s transforming healthcare across the globe. If you are excited about managing regulatory software, supporting international applications, and working in an international environment, this could be the perfect next step in your career.

 

Job description:

 

 

• Take charge of administering and maintaining our cutting-edge software for regulatory submissions, ensuring smooth electronic filings and data submissions to health authorities.
• Provide vital 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).
• Become a champion for 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.

 

Qualifications: 

 

• University or high school degree.
• Fluent in English (at least B2 level).
• Understanding of databases is advantageous
• You're a reliable, adaptable team player with excellent communication skills, and you thrive in an international setting.
• You’re 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.

 

We offer you:

 

• Work within a highly motivated and engaged international team
• 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.

 

Only shortlisted candidates will be contacted.