Regulatory Affairs Specialist
1 semana atrás
We are looking for a Regulatory Affairs & Medical Affairs Specialist to join our team in Portugal. This is a dynamic role combining Regulatory Affairs, Medical Affairs, and Market Access responsibilities. You will play a key role in supporting product launches, ensuring regulatory compliance, and driving pricing and reimbursement processes. ResponsibilitiesREGULATORY AFFAIRS: Develop and maintain a strong understanding of EU and Portuguese regulatory requirements. Prepare, submit, and track regulatory documentation in line with current legislation and company standards. Manage national procedures, translations, database validations, and communication with authorities. Ensure timely updates of Marketing Authorizations, labeling compliance, and inspection readiness. Build and maintain effective relationships with local regulatory authorities and relevant associations. Monitor regulatory changes and share critical updates with internal stakeholders. Medical Review and approve educational, promotional, and non-promotional materials for compliance. Support training activities related to new product launches. Act as a liaison with external stakeholders, including Key Opinion Leaders. Market Access Support pricing and reimbursement (P&R) submissions for retail and hospital products. Ensure compliance with national legislation, including annual price revisions. Follow internal pricing processes and international reference pricing (IRP) requirements. Must-Have Qualifications Proven experience in Regulatory Affairs, including: DCP (Decentralised Procedure) MRP (Mutual Recognition Procedure) Portugal acting as RMS (Reference Member State) Strong knowledge of national regulatory processes and authority interactions. Experience with regulatory submissions, labeling, and compliance. Nice-to-Have Experience in promotional material review and development. Knowledge of Market Access processes (pricing and reimbursement). Familiarity with advertising regulations for pharmaceutical products. Requirements Degree in Pharmacy, Life Sciences, or related field. Fluency in Portuguese and English (written and spoken). Excellent organizational and communication skills.
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Regulatory Affairs Specialist
2 semanas atrás
Parque Urbano de Miraflores, Portugal Zentiva Tempo inteiroWe are looking for a Regulatory Affairs & Medical Affairs Specialist to join our team in Portugal. This is a dynamic role combining Regulatory Affairs, Medical Affairs, and Market Access responsibilities. You will play a key role in supporting product launches, ensuring regulatory compliance, and driving pricing and reimbursement processes. RESPONSIBILITIES...
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Regulatory Affairs Specialist
2 semanas atrás
Miraflores, Lisbon, Portugal Zentiva Tempo inteiroWe are looking for a Regulatory Affairs & Medical Affairs Specialist to join our team in Portugal. This is a dynamic role combining Regulatory Affairs, Medical Affairs, and Market Access responsibilities. You will play a key role in supporting product launches, ensuring regulatory compliance, and driving pricing and reimbursement...
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Regulatory Affairs Specialist
2 semanas atrás
Portugal / Miraflores Zentiva Tempo inteiroWe are looking for a Regulatory Affairs & Medical Affairs Specialist to join our team in Portugal. This is a dynamic role combining Regulatory Affairs, Medical Affairs, and Market Access responsibilities. You will play a key role in supporting product launches, ensuring regulatory compliance, and driving pricing and reimbursement...
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Paço De Arcos, Portugal Laboratório Edol - Produtos Farmacêuticos, S.A. Tempo inteiroA leading pharmaceutical company in Lisbon is seeking a Regulatory Affairs Specialist to oversee regulatory compliance, support product launches, and drive pricing processes. Candidates must have experience in regulatory affairs, a degree in a related field, and be fluent in both Portuguese and English. This full-time role combines responsibilities in...
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Regulatory Affairs Specialist
Há 2 dias
Área Metropolitana de Lisboa, Portugal Hays Tempo inteiroRegulatory Affairs Specialist (m/f/d) | Empresa de Consultoria Farmacêutica A empresa onde vai trabalhar Integre uma empresa de consultoria para a Indústria Farmacêutica, assumindo a função de Regulatory Affairs Specialist. A sua nova função Este profissional será responsável pela preparação e submissão de pedidos de AIM (procedimento...
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Regulatory Affairs Specialist
Há 2 dias
Área Metropolitana de Lisboa, Portugal Hays Tempo inteiroRegulatory Affairs Specialist (m/f/d) | Empresa de Consultoria FarmacêuticaA empresa onde vai trabalharIntegre uma empresa de consultoria para a Indústria Farmacêutica, assumindo a função de Regulatory Affairs Specialist.A sua nova funçãoEste profissional será responsável pela preparação e submissão de pedidos de AIM (procedimento nacional,MRP e...
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Paço De Arcos, Portugal Laboratório Edol - Produtos Farmacêuticos, S.A. Tempo inteiroO Laboratório Edol, empresa do Grupo Faes Farma, pretende reforçar a sua equipa de Assuntos Regulamentares com um Técnico de Assuntos Regulamentares – Mercado Nacional & Exportação (Regulatory Affairs Specialist) , para as suas instalações de Carnaxide. Esta vaga será para substituição de uma licença de maternidade. Principais...
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Especialista Em Regulação De Produtos De Saúde
1 semana atrás
Paço De Arcos, Portugal Laboratório Edol - Produtos Farmacêuticos, S.A. Tempo inteiroO Laboratório Edol, empresa do Grupo Faes Farma, pretende reforçar a sua equipa de Assuntos Regulamentares com um Técnico de Assuntos Regulamentares – Mercado Nacional & Exportação (Regulatory Affairs Specialist), para as suas instalações de Carnaxide. Esta vaga será para substituição de uma licença de maternidade. Principais...
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Internship Regulatory Affairs
1 semana atrás
Paço De Arcos, Portugal IQVIA Tempo inteiroJob Description Are you looking for an internship to learn and develop, take a peek into the professional world while bringing in your individual contribution? Would you like to experience working in one of the biggest multinationals in the pharmaceutical industry? We are looking for a graduating student or Master student; you must be searching for a...
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Associate Telesales Specialist
Há 21 horas
Miraflores Alges Portugal Cryoport Systems Tempo inteiroCRYOPDP, now part of DHL Supply Chain, has been dedicated to finding solutions for the transport of time - and temperature-sensitive products in the life science and healthcare industries for more than 25 years. CRYOPDP covers more than 220 countries and territories and the entire temperature-controlled supply chain: packaging, pick pack kit preparation,...
