Location: Belgrade

Type of contract: Maternity cover

Job Description:
We are seeking a dedicated and detail-oriented Regulatory Specialist to join our Regulatory Affairs team. The role involves managing regulatory activities for pharmaceutical products, ensuring compliance with local and international standards, and contributing to the successful realization of regulatory processes.

Key Responsibilities:

• Prepare and coordinate regulatory documentation for product registration, variations, and renewals.
• Collaborate with internal teams and external partners to gather required data and documentation.
• Ensure timely submission of regulatory dossiers and follow up on approval processes.
• Monitor and implement updates in regulatory requirements and trends in relevant markets.
• Maintain and update regulatory databases and archives.
• Act as a mentor for junior colleagues, providing training and guidance.
• Suggest and implement process improvements to enhance efficiency and compliance.
• Foster strong relationships with cross-functional teams, including R&D, Marketing, and Quality Assurance, to support product lifecycle management.

Requirements:

• University degree in Pharmacy, Medicine, or Technology (Pharmaceutical, Medical, or Technological Faculty).
• Previous experience in regulatory affairs or a related field is an advantage.
• Proficiency in English (written and spoken).
• Strong computer literacy and familiarity with regulatory databases.
• Excellent organizational skills and attention to details

We offer you:

• Private health insurance (with the option of preferential use for family members)
• Continuous professional development through specialized education and training
• A platform for learning 14 foreign languages, through various learning methods, including conversational courses
• Personalized mental health and well-being support for employees and their families through the Kyan Health app