Regulatory Affairs and Pharmacovigilance Specialist

Be a part of the winning culture!

At Zentiva, we are a team of 4,800 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 and Pharmacovigilance Specialist

Currently, we are looking for a Regulatory Affairs and Pharmacovigilance Specialist to join our highly motivated and inspired team in Zentiva Croatia. This is a great opportunity to join us on a fixed-term contract, with the potential to grow into a long-term role within the company.

This multi-functional role spans across Regulatory Affairs, Pharmacovigilance, Quality, Medical Affairs and Market Access, with a goal of ensuring access to high-quality, affordable medicines and helping people live well.

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 bodies;

Review and approve artwork and product labeling;

Maintain the PV system and support ADR reporting;

Deliver PV and product training to employees;

Manage quality documentation (SOPs, CAPAs, change control);

Support the development of medical materials, internal training & medical inquiries;

Prepare reimbursement dossiers and pricing strategies;

Conduct national and international reference pricing to support pricing and reimbursement maintenance;

Ensure compliance in advertising and promotional activities.

We Need You To Have

University degree in life sciences (pharmacy, medicine, dental medicine, etc.);

Knowledge of regulatory, pharmacovigilance, and quality principles;

Excellent English (written & spoken);

Advanced computer skills;

Growth mindset, detail-oriented, proactive and well-organized.

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

Competitive salary;

Additional benefit package;

Hybrid mode of work;

International working environment and a passionate team of professionals;

Continuous Learning & Development opportunities.

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