Junior Regulatory Affairs Officer

About the role

Join Servier Monde in Zagreb as a Junior Regulatory Affairs Officer and support the regulatory lifecycle of medicines, ensuring compliance with Croatian, European and company standards.

Key responsibilities

• Prepare, submit and follow‑up regulatory documentation for new registrations, variations, renewals and product maintenance.
• Maintain regulatory databases, submission records and correspondence according to local procedures.
• Assist with local labelling, packaging materials and implementation of approved changes.
• Track regulatory changes, gather intelligence and provide practical guidance to colleagues.
• Support communication with competent authorities and respond to requests together with senior colleagues.
• Collaborate with cross‑functional teams on pharmacovigilance, quality/recall actions, inspections, audits and SOP updates.

Required profile

• University degree in pharmacy.
• Initial experience or strong interest in Regulatory Affairs within the pharmaceutical industry.
• Basic understanding of Croatian and European pharmaceutical regulations (advantageous).
• Strong attention to detail, organisational skills and ability to manage documentation accurately.
• Clear written and verbal communication skills in English.
• Proactive, collaborative attitude with a willingness to learn and develop.