Regulatory Affairs and Pharmacovigilance Specialist

About the role

Join Zentiva's global team in Croatia as a Regulatory Affairs & Pharmacovigilance Specialist. This maternity‑leave replacement offers exposure to regulatory, pharmacovigilance, quality, medical affairs and market access functions.

Key responsibilities

• Maintain and update marketing authorisations and propose local regulatory strategies.
• Ensure compliance with local and EU regulations and build relationships with authorities.
• Review and approve artwork, product labelling and promotional materials.
• Maintain the PV system, support ADR reporting and deliver PV/GxP trainings.
• Manage product quality complaints, investigations and quality documentation (SOPs, CAPAs, change control).
• Handle medical inquiries and prepare reimbursement dossiers and pricing strategies.

Required profile

• University degree in Life Sciences (Pharmacy, Medicine, Dental Medicine or related).
• Knowledge of Regulatory Affairs, Pharmacovigilance and Quality Management principles.
• Strong communication, collaboration and detail‑oriented approach.
• Excellent written and spoken English and fluency in Croatian.

Required skills

• Proficiency in MS Office.
• Experience with electronic document management systems.
• Experience with quality management systems.

What we offer

• Competitive salary and private health insurance.
• Company car, laptop and mobile phone.
• International working environment and continuous learning via Zentiva Academy.