Num relance
- Tarefas: Liderar atividades de rotulagem na Europa, garantindo conformidade regulatória e excelência operacional.
- Empresa: Empresa global de saúde dedicada a melhorar o acesso a medicamentos de qualidade.
- Benefícios: Pacote competitivo de compensação e benefícios, com foco em crescimento profissional.
- Outras informações: Ambiente colaborativo e internacional que valoriza diversidade e inclusão.
- Porquê este emprego: Impacte vidas ao garantir que produtos essenciais cheguem ao mercado de forma eficaz.
- Qualificações: Licenciatura em Ciências da Vida e 5 anos de experiência em rotulagem e assuntos regulatórios.
O salário previsto situa-se entre 173250 - 211750 € por ano.
Lead European labelling activities, ensuring regulatory compliance and timely delivery of product labelling updates while driving operational excellence.
Client Details Our client is a global healthcare company committed to improving access to high-quality medicines and healthcare solutions worldwide.
Focused on improving patients' lives, the company delivers essential treatments and supports healthcare needs across all stages of life.
Description
Lead and oversee regional labelling activities across Europe for both generic and branded products, ensuring regulatory compliance, operational excellence and the timely implementation of labelling updates throughout the product lifecycle.
Manage, coach and develop a high-performing labelling team, setting clear objectives and fostering a collaborative environment focused on quality, accountability and continuous improvement.
Provide strategic regulatory leadership and expert guidance on EU labelling requirements, including the interpretation of regulations, CCDS assessments, health authority interactions and the development of labelling strategies for new and marketed products.
Partner closely with Regulatory Affairs, Medical Affairs, Quality, Supply Chain, Launch Management and Legal teams to ensure seamless end-to-end execution from regulatory approval through artwork implementation and market release.
Drive continuous improvement initiatives, maintain awareness of emerging regulatory requirements, support audits and inspections, and ensure adherence to company procedures, governance standards and best practices.
Profile Degree in Life Sciences, Pharmacy, Biotechnology or a related scientific discipline, combined with a minimum of 5 years' experience in product labelling and regulatory affairs within the pharmaceutical, biotechnology or healthcare sector.
Proven leadership experience in managing and developing high-performing teams, as well as leading cross-functional initiatives within complex, matrix-driven organisations.
Strong expertise in global and European labelling regulations and processes, including Sm PC, PIL and CCDS, with the ability to develop compliant and effective labelling strategies.
Excellent stakeholder management, communication and project leadership skills, with a demonstrated ability to influence across functions and drive complex projects to successful completion.
Experience with electronic submission and change control systems, such as Lorenz and Track Wise®, as well as document management platforms, would be considered advantageous.
Job Offer The company offers a competitive compensation and benefits package, as well as the opportunity to work in a collaborative, international, and cross-functional environment that values diversity, inclusion, and professional growth.
Empregador para Senior Regulatory Affairs & Labeling Manager in Lisbon: Michael Page
A Michael Page é um excelente empregador, oferecendo um ambiente de trabalho colaborativo e dinâmico em Oeiras, onde os colaboradores têm a oportunidade de desenvolver as suas competências na área da contabilidade. Com um forte foco no crescimento profissional, a empresa proporciona formação contínua e oportunidades de progressão na carreira, além de um pacote de benefícios atrativo que valoriza o bem-estar dos seus funcionários.
