Regulatory Affairs & Pharmacovigilance Specialist

What Would Be Your Main Responsibilities

• Maintain and update marketing authorizations
  Propose and execute local regulatory strategies
  Ensure compliance with local & EU regulations
• Build and maintain effective relationships with regulatory authorities
• Review and approve artwork and product labelling
  Maintain the pharmacovigilance (PV) system and support adverse drug reaction (ADR) reporting
• Manage product quality complaints (PQCs) and coordinate investigations and follow-up activities with relevant stakeholders
• Manage medical inquiries and ensure timely, accurate responses in line with corporate standards
• Deliver PV and GxP trainings to employees
  Manage quality documentation (SOPs, CAPAs, change control)
  Prepare reimbursement dossiers and pricing strategies, including national and international reference pricing analyses
• Review and approve promotional materials, activities and healthcare professional (HCP) engagements in line with corporate policies and applicable regulatory requirements

We Need You To Have

• University degree in Life Sciences (Pharmacy, Medicine, Dental Medicine, or a related field)
• Knowledge of Regulatory Affairs, Pharmacovigilance, and Quality Management principles
• Familiarity with Market Access and Medical Affairs activities is an advantage
• Ability to manage diverse responsibilities and priorities in a broad cross-functional role
• Growth mindset, with a proactive, structured, and detail-oriented approach
• Strong communication and collaboration skills, with the ability to work effectively across multiple functions and stakeholders
• Excellent command of English, both written and spoken, and fluency in Croatian
• Proficiency in MS Office and experience with electronic document management and quality management systems
• Previous experience in the pharmaceutical industry, Regulatory Affairs, Pharmacovigilance, Quality Assurance, or a related field is an advantage

It is crucial for us to have satisfied employees. Therefore, we can offer you the following:

• Competitive salary;
• Additional benefit package including Private health insurance;
• Company car, laptop, mobile phone;
• International working environment and a passionate team of professionals;
• Continuous Learning & Development opportunities thanks to our Zentiva Academy.

Why join us?

At Zentiva, you will be part of an international pharmaceutical group with a strong local presence. We empower our people to grow, take ownership, and make an impact, while offering opportunities for professional development, continuous learning, and cross-functional collaboration in a supportive and dynamic environment. We value collaboration, responsibility and innovation, and support our colleagues in building meaningful careers while helping communities live well.

The successful candidates will gain valuable experience within an international pharmaceutical company and become part of a collaborative and supportive team environment. As our business evolves, additional career opportunities may arise within the organization, subject to business needs and organizational requirements.

If you’re ready to make an impact and grow with us, apply now!
Send your CV and motivational letter in English via the application link.