Regulatory Team Leader

The position exists to participate in the regulatory program of our pharmaceutical partner, being part of a global team and leading a team which is part of it.Job LocationBudapest, Hungary 9th District – Mill Park Office BuildingWorking Hours⏰ 40 hours per week✅ Normal business hoursOffice attendance: Once a weekOfferCompetitive salary and cafeteria benefits; All You Can Move SportPass (at a discounted price), annual bonus, medical benefits, and other perksRisk and accident insuranceChance to be part of a rapidly expanding organizationTraining and continuous learning and certification opportunitiesMultilingual environment, native colleaguesPleasant and inspiring working atmosphere with multicultural community and state-of-the-art technologiesEasy-to-access location and modern office building (easy to reach from city center, 10–15 minute commute)Reimbursable language coursesRequirementsEducation: Bachelor’s degree in Life Sciences or PharmacyExperience:2–5 years of professional experience in Regulatory AffairsHands-on experience in Pharmacovigilance (PV) data handlingSkills:Strong attention to detail and accuracy in documentationGood understanding of regulatory guidelines and compliance standardsProficiency in data management tools and MS Office applicationsLanguage: Excellent written and spoken English (additional languages are a plus)Tasks And Responsibilities Tracking different regulatory submissions in the corporate regulatory database – update database with specific documents and/or information Running daily queries, providing reports to client stakeholders Applying technical knowledge to perform quality check on the entries Ensuring compliance with KPIs Optimizing utilization and effective resource allocation planning for the team 100% compliance for work allocation Good team management (indicated through no major escalations) Ensure adherence to Cognizant and Client SOPs (Standard Operating Procedure) or internal standards and processes Responsible for regular FMEA update and CAPA management Managing BCP and operations Effective risk management and issue handling by conducting daily huddle and escalating them on time Communicating with client representative, understanding client expectations Establishing and developing processes and procedures in the team Complete all mandatory training courses as applicable Communicating issues to Delivery Site Lead