Regulatory Affairs Specialist
hace 2 semanas
IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics, and human ingenuity to drive healthcare forward. Join our dynamic Lifecycle Management team as a Regulatory Affairs Specialist supporting post-approval regulatory activities for human medicinal products in Spain . This is an individual contributor role ideal for professionals with at least 4 years of experience in regulatory affairs on Spanish market. Key Responsibilities Collaborate with local teams to prepare and submit regulatory documents (notifications, renewals, variations, new applications, MAH transfers) to local Health Authorities. Support the regulatory approval process and ensure compliance with local and international requirements. Build and maintain strong relationships with internal stakeholders and external partners. Participate in meetings with our clients - global pharmaceutical companies. Communicate with Regulatory Agencies. Qualifications Bachelor’s or Master’s degree in Life Sciences or related field. Minimum 4 years of experience in post-approval regulatory affairs for Spanish market. Solid understanding of AEMPS (Spanish Health Authority) regulatory guidelines. Experience in submissions of new marketing authorizations, variations, renewals. Fluent in English & Spanish . Strong organizational and time management skills. Proficiency in Microsoft Office. Ability to work independently and adapt in a fast-paced environment. IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. #J-18808-Ljbffr
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Senior Regulatory Affairs Specialist
hace 1 semana
Madrid, Madrid, España Indero (formerly Innovaderm) A tiempo completoThe Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions.This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...
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Senior Regulatory Affairs Specialist
hace 1 semana
Madrid, Madrid, España Indero A tiempo completoThe Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions.This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...
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Lead Regulatory Affairs Specialist
hace 2 semanas
madrid, España Eurofins A tiempo completoA global life sciences company in Madrid is seeking a Regulatory Affairs Specialist - Group Leader for Crop Protection. This role involves managing regulatory registration dossiers, ensuring compliance with EU requirements, and mentoring team members. The ideal candidate has at least 5 years of experience in regulatory affairs, a strong scientific...
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Senior Regulatory Affairs Specialist
hace 1 semana
Madrid, España Indero A tiempo completoThe Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions. This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...
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Regulatory Affairs Specialist
hace 1 semana
Madrid, España Indero A tiempo completoOverview Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and / or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and...
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Regulatory Affairs Specialist
hace 1 semana
Madrid, España Indero A tiempo completoOverviewInscríbase rápido, consulte la descripción completa desplazándose hacia abajo para conocer todos los requisitos de este puesto.Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and / or part II following EU CTR and other...
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Regulatory Affairs Specialist
hace 3 días
Madrid, España Indero A tiempo completoOverview Due to ongoing global expansion, Indero is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for preparation and submission of part I and / or part II following EU CTR and other applications created within or outside of the company to ensure documentation comply with applicable regulations and guidelines and...
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Home-based Regulatory Affairs Specialist — CTIS
hace 1 semana
Madrid, España Indero A tiempo completoA contract research organization is seeking a Regulatory Affairs Specialist in Madrid.Por favor, lea detenidamente la información de esta oferta de empleo para entender exactamente qué se espera de los posibles candidatos.The role involves preparing and submitting regulatory documentation, ensuring compliance with EU regulations, and coordinating timelines...
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Senior Regulatory Affairs Specialist – Market Access
hace 2 semanas
madrid, España ABACUS MEDICINE A tiempo completoA pharmaceutical company is seeking a Senior Regulatory Affairs Specialist in Madrid. You will ensure compliance by obtaining parallel trading licenses and preparing packaging materials. Candidates should have a relevant degree and at least 2 years of experience in the pharmaceutical industry. Proficiency in English and local language is required. This role...
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Senior Regulatory Affairs Specialist
hace 2 semanas
Madrid, España Indero A tiempo completoThe Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global / multinational complex large clinical trial submissions.This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables...
