Regulatory Affairs and Pharmacovigilance Specialist

About the role

Be a part of the winning culture!

At Zentiva, we are a team of 5,000 unique talents bonded together by our common mission. We believe our diversity is a source of great energy and strength, and we create a work culture and ethics where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking a balanced team across the company we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love.

Regulatory Affairs & Pharmacovigilance Specialist

Currently, we are looking for a Regulatory Affairs & Pharmacovigilance Specialist to join our highly motivated and inspired global team in Zentiva 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

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

• Competitive salary;
• Additional benefit package;
• Laptop, mobile phone;
• International working environment and a passionate team of professionals;
• Continuous Learning & Development opportunities thanks to our Zentiva Academy.