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
Type of contract: Fix term – Maternity cover

About the job:

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.

Responsibilities:

• 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.

Qualifications:

• 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.

We offer:

• 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.