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 Zentiva Croatia team.

This position has been created due to the expansion of our business and reflects our long-term commitment to strengthening operations in Croatia. 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 labelling

Maintain the PV system and support ADR reporting

Deliver PV and product training to employees

Manage quality documentation (SOPs, CAPAs, change control)

Prepare reimbursement dossiers and pricing strategies, including national and international reference pricing analyses to support pricing and reimbursement maintenance

Support development of medical materials, internal training & medical inquiries

Ensure compliance in advertising and promotional activities

Approve engagements HCPs in line with corporate and regulatory standards

We Need You To Have

University degree in life sciences (Pharmacy, Medicine, Dental Medicine, or related field)

Knowledge of regulatory, pharmacovigilance, and quality principles

Familiarity with market access and medical affairs processes is an advantage

Excellent command of English (written & spoken) and fluency in Croatian

Advanced computer skills (MS Office, eDMS, Quality Forward)

Growth mindset; detail-oriented, structured, proactive, and well-organized

Strong communication and collaboration skills with the ability to work cross-functionally in a hybrid role

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

Competitive salary.

International working environment and a passionate team of professionals 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.

This is a great opportunity to join us in a permanent position, created as part of our business growth. 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.

Diversity is a fact. Inclusion is an act @Zentiva

At Zentiva, we are a team of almost 4,800 unique talents bonded together by our mission to deliver high quality medicine to people whose lives depend on it. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love. Join our winning team! Be a part of our winning culture! Be Zentiva

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