Regulatory Affairs Specialist
Há 6 horas
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. RESPONSIBILITIES REGULATORY 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
Há 6 horas
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....
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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. ...
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Regulatory Affairs Specialist
Há 6 dias
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
Há 6 dias
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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Regulatory Affairs Specialist
2 semanas atrás
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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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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Regulatory Affairs Trainee
1 semana atrás
Vale de Cambra, Portugal Colep Consumer Products Tempo inteiroWe are looking for a Regulatory Affairs Trainee to join our R&D team to collaborate in the reception, verification, organization, management and update of raw and packaging materials as well other required documentation under the responsibility of R&D and other specific tasks. **Main Activities and Responsibilities**: - Support in the organization,...
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Vila Nova de Famalicão, Portugal Continental Tempo inteiroCompany Description Continental develops pioneering technologies and services for sustainable and connected mobility of people and their goods. Founded in 1871, the technology company offers safe, efficient, intelligent and affordable solutions for vehicles, machines, traffic and transportation. In 2024, Continental generated sales of €39.7 billion and...
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Cybersecurity Specialist for Dig. Solutions Products
1 semana atrás
Vila Nova de Famalicão, Portugal Continental Tempo inteiroCompany Description Continental develops pioneering technologies and services for sustainable and connected mobility of people and their goods. Founded in 1871, the technology company offers safe, efficient, intelligent and affordable solutions for vehicles, machines, traffic and transportation. In 2024, Continental generated sales of €39.7 billion and...
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Quality Assurance Specialist
Há 6 horas
Rio de Mouro, Portugal kencko Tempo inteiroOur Mission We make it easy for everyone to build healthy habits and eat more fruit and vegetables by creating innovative products that are highly nutritious, sustainable and delicious. How We Do It Just 1 in 10 US adults eats the recommended minimum of 5 cups of fruits and vegetables every day. We're helping solve that problem with convenient, organic, and...
