Regulatory Affairs Specialist

hace 3 semanas


Madrid, España EPM Scientific A tiempo completo

We're seeking a detail-oriented and proactive Senior Regulatory Associate to support the preparation and submission of high-quality regulatory documentation. This is a fantastic opportunity for professionals with 1-3 years of experience in Regulatory Affairs who are ready to take the next step in their career.Key Responsibilities:Publish, dispatch, and archive regulatory submissions in agency-recommended formats.Ensure timely delivery of compliant, high-quality submissions aligned with client and internal standards.Format, hyperlink, and process submission-ready documents using MS Word and Adobe Acrobat.Troubleshoot technical issues related to document formatting and publishing tools.Collaborate cross-functionally to plan, prepare, and perform quality control checks on submissions.Support regulatory audits and compliance activities.Maintain up-to-date knowledge of agency standards and submission procedures.Manage technical aspects and provide status updates for assigned submissions.Use publishing and validation tools effectively.Mentor junior staff and contribute to SOPs, work instructions, and training materials.What We're Looking For:Experience: 3+ years in Regulatory Affairs within the pharmaceutical industry.Strong knowledge of electronic submission standards and tools.Proficiency in MS Word, Adobe Acrobat, and publishing/validation platforms.Excellent communication and collaboration skills.Ability to work independently and manage multiple priorities.



  • madrid, España IQVIA A tiempo completo

    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....


  • madrid, España IQVIA A tiempo completo

    A leading healthcare data company is seeking a Regulatory Affairs Specialist to support post-approval regulatory activities for human medicinal products in Spain. This role requires at least 4 years of experience in regulatory affairs and proficiency in English and Spanish. Responsibilities include preparing regulatory documents, ensuring compliance with...


  • Madrid, España Indero A tiempo completo

    The 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...


  • madrid, España Indero (formerly Innovaderm) A tiempo completo

    Regulatory Affairs Specialist (Spain) Company: Indero (formerly Innovaderm) Indero, a Contract Research Organization (CRO) specializing in dermatology and rheumatology, is expanding globally and seeks a Regulatory Affairs Specialist for Spain. Responsibilities Preparation of regulatory documents, CTA packages, and submissions in assigned countries to ensure...


  • Madrid, Madrid, España Indero (formerly Innovaderm) A tiempo completo

    The 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...


  • Madrid, Madrid, España Indero A tiempo completo

    The 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...


  • madrid, España Eurofins A tiempo completo

    A 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...


  • Madrid, España Indero A tiempo completo

    The 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...


  • Madrid, España Indero A tiempo completo

    OverviewInscríbase 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...


  • Madrid, España Indero A tiempo completo

    Overview 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...