Regulatory Affairs & Pharmacovigilance Specialist

Zentiva

Zagreb, Croatia

While this position is being offered as a maternity leave replacement, it represents an excellent opportunity to build expertise across multiple disciplines, work closely with local and international stakeholders, and develop a broad understanding of the pharmaceutical industry. This hybrid role spans Regulatory Affairs, Pharmacovigilance, Quality Assurance, Medical Affairs and Market Access, offering exceptional exposure, diverse learning opportunities, and the chance to make a meaningful contribution to patient access to high-quality, affordable medicines.

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