EU Senior Global Reg Affairs Project Leader (m/f/d)

The EU Senior Global Reg Affairs Project Leader (m/f/d) role at Viatris Innovation GmbH involves defining and executing EU regulatory strategies. Viatris is a global healthcare company that combines generics and brand medicines to address healthcare needs worldwide. The company supplies high-quality medicines to approximately 1 billion patients annually and is committed to creating healthier communities through education, outreach, and better access to treatment. The main day-to-day responsibilities include serving as the primary EU regulatory contact with the European Medicines Agency (EMA) and coordinating interactions with National Competent Authorities. The role also involves leading the preparation and execution of Scientific Advice, regulatory meetings, and related briefing packages. Additionally, the position oversees EU regulatory submissions, ensures EU labeling compliance, and represents Regulatory Affairs on cross-functional project and governance teams. The role also involves maintaining regulatory intelligence, contributing to due diligence and business development activities, and developing global regulatory strategies. To qualify for this role, candidates must have a Master's degree (or equivalent) in Life Sciences or a related discipline, along with 8+ years of Regulatory Affairs experience within the pharma or biotech industry. Expert knowledge of EU, ICH, and global regulatory frameworks is essential, as is extensive experience working with the EMA and EU National Competent Authorities. Strong understanding of clinical development and regulatory life-cycle activities, as well as excellent communication, stakeholder management, and project leadership skills, are also required. Fluency in English, both written and spoken, is a must. Nice-to-have skills include the ability to work in a friendly atmosphere with a home office option up to 2 days per week. The role offers development opportunities within an international company and the chance to work in a diverse, inclusive, and authentic workplace. Viatris is dedicated to building a diverse and inclusive environment, and encourages candidates who may not fully align with every requirement to apply. What the role asks for: - Master's degree (or equivalent) in Life Sciences or related discipline - 8+ years of Regulatory Affairs experience within pharma or biotech - Expert knowledge of EU, ICH, and global regulatory frameworks - Extensive experience working with EMA and EU National Competent Authorities - Strong understanding of clinical development and regulatory life-cycle activities - Excellent communication, stakeholder management, and project leadership skills - Fluency in English (written and spoken)