Regulatory Affairs and Pharmacovigilance Specialist
- Česko
- Trvalý pracovní poměr
- Plný úvazek
- 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
- 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
- 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.