Job Opportunities API

The Opportunity Our client is an internationally operating pharmaceutical organization seeking an experienced Regulatory Affairs professional. This position offers broad regulatory responsibilities across the full product lifecycle within a collaborative international environment. Regulatory Affairs Manager (m/f/d) Location: Leipzig (in combination with homeoffice) Aufgaben • Drive regulatory submissions across multiple international markets. • Prepare high-quality regulatory dossiers and lifecycle applications. • Review scientific documentation for submission readiness. • Ensure regulatory compliance throughout development activities. • Provide regulatory guidance to internal stakeholders. • Evaluate regulatory consequences of proposed product changes. • Update product labeling and regulatory documentation. • Handle authority questions and regulatory correspondence. • Support implementation of health authority commitments.Collaborate with external partners and regulatory agencies. Qualifikation • Scientific or pharmaceutical academic background. • Professional Regulatory Affairs experience. • Understanding of European regulatory procedures. • Strong organizational and planning skills. • Analytical mindset with attention to detail. • Experience using regulatory documentation systems. • Confident communicator across multidisciplinary teams. • Fluent German (C1) and English communication skills. • Willingness to travel occasionally. Benefits • Hybrid working model with flexible scheduling. • Challenging international regulatory responsibilities. • Supportive leadership and collaborative colleagues. • Individual learning and career development. • Competitive compensation and comprehensive benefits. • Stable employer with long-term opportunities. Contact: Silvio Di Meglio CEO TRIGA Consulting 089-809130721