Regulatory Affairs Technician

Description

Job Summary: The International Regulatory Affairs Technician at Medinfar ensures the submission and maintenance of Marketing Authorization applications for pharmaceuticals in international markets. Key Highlights: 1. Work with real impact on drug safety. 2. A purpose-driven team grounded in scientific rigor and ethics. 3. Opportunity for professional growth and collaboration. At **Medinfar**, your work makes a real difference: helping ensure the quality and safety of medicines reaching those who need them. Join a team driven by **purpose, scientific rigor, ethics, and commitment to health**. **Together, we care better.** #### **YOUR ROLE AT MEDINFAR** As the **International Regulatory Affairs Technician**, you will be responsible for ensuring the submission and maintenance of Marketing Authorizations (MAs) for human-use medicinal products in international markets. #### **HOW WILL YOU MAKE A DIFFERENCE?** * **New MA Applications:** Execute all technical-scientific and administrative activities related to MA applications and submissions, ensuring compliance with local and global requirements; * **MA Dossier Updates and Maintenance:** Identify, collect, and organize technical, scientific, and administrative documentation required for maintaining MA dossiers (e.g., notifications, variations, renewals), ensuring adaptation to scientific and technological progress; * **Regulatory Response Preparation:** Draft and compile responses to queries from Competent Authorities, ensuring adherence to established deadlines; * **Artwork Management:** Prepare, review, and approve final texts and artwork for printed packaging materials, ensuring regulatory compliance; * **Cross-functional / Inter-departmental Collaboration:** Collaborate with internal teams (production, quality, marketing, supply chain) and external partners to ensure alignment and efficiency in regulatory processes. #### **WHAT ARE WE LOOKING FOR?** * Bachelor’s degree (pre-Bologna) or Integrated Master’s degree (post-Bologna) in **Pharmaceutical Sciences** (or equivalent field); * Minimum 1–2 years of experience; * Good command of English (spoken and written); * Proficiency in end-user computer skills (Microsoft Office) and familiarity with regulatory-support software; * Effective communication and interpersonal relationship skills; * Critical thinking and analytical ability. #### **WHY MEDINFAR?** Because here you’ll find more than just a regulatory role. You’ll find real impact, professional growth, and a team that values rigor, collaboration, and the purpose of caring for health. Together, we care better.