Senior lægemiddelrådgiver til lægemiddelimplementering med ansvar for avancerede terapier (ATMP)

This senior role as a lægemiddelrådgiver (pharmaceutical advisor) specializing in drug implementation with responsibility for advanced therapy medicinal products (ATMP) requires extensive expertise in pharmaceutical sciences and drug development processes. The candidate must possess in-depth knowledge of ATMPs, including gene therapies, somatic-cell therapies, and tissue-engineered products, ensuring compliance with regulatory frameworks and guidelines specific to these innovative treatments. Experience in drug implementation indicates a strong background in translating clinical and regulatory requirements into practical application within healthcare or pharmaceutical settings. The role demands advanced advisory skills to support cross-functional teams in the integration of ATMPs into treatment protocols, addressing challenges related to manufacturing, quality assurance, safety, and efficacy. A senior level implies significant prior experience in pharmaceutical consultancy or regulatory affairs, with proven ability to manage complex projects and provide strategic guidance on advanced therapies. Strong communication and stakeholder management skills are essential to liaise effectively with regulatory authorities, healthcare providers, and internal teams. Familiarity with relevant legislation, such as EMA guidelines and national regulations governing ATMPs, is critical. Overall, this position requires a highly qualified professional with a comprehensive understanding of advanced medicinal therapies, drug implementation strategies, regulatory compliance, and the ability to lead initiatives that facilitate the successful adoption of cutting-edge pharmaceutical products.