Regulatory Affairs Specialist
hace 2 semanas
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 high quality standards. Coordination of regulatory timelines and deadlines for all assigned projects planned for CTIS submissions, primarily EU but also APAC and North America. Review of regulatory documents and submissions created outside the company by subcontractors (e.g., partner CROs, regulatory vendors) to ensure high quality standards before submission to CTIS. Point of contact for sponsors and subcontractors/project management teams for all aspects related to study regulatory submissions. Preparation or review of country‑specific Patient Information Sheet/ Informed Consent Form documents. Preparation or review of study‑specific templates of regulatory forms. Manage translation requests with vendor. Provide regulatory support and advice to project teams and key internal/external customers on local requirements, EU submission strategy, and technical expertise. Maintain up‑to‑date knowledge of EU CTR and EU/EEA local requirements relevant to the company. Maintain the regulatory intelligence database. Participate in kick‑off meetings, audits, and other project‑related meetings according to company/client needs. Qualifications Education Bachelor's degree (or equivalent) in a scientific discipline. Experience Minimum of 2-3 years of clinical research experience (CRO or Pharma) working in Poland regulatory affairs. Experience in initial CTA is essential. Experience in a sponsor‑facing role is an asset. Previous experience with CTIS is an asset. Hands‑on experience preparing, reviewing, and submitting regulatory documentation. Knowledge and Skills Excellent knowledge of applicable EU regional / national country regulatory guidelines (Poland, Spain, Germany, France, Netherlands). Excellent knowledge of GCP and ICH standards. Fluency in English with excellent oral and written skills (required). Additional languages represent an asset. Excellent organization and communication skills; great attention to detail. Ability to organize own work, prioritize different assignments, and work under pressure. Versatile and comfortable in a multitasking environment. Respect established timelines, expectations, priorities, and objectives. Benefits Permanent full‑time position. Flexible schedule. Vacation. Home‑based position. Ongoing learning and development. Location: Madrid, Community of Madrid, Spain. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Spain. #J-18808-Ljbffr
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Regulatory Affairs Specialist
hace 2 semanas
Madrid, Madrid, España Johnson & Johnson MedTech A tiempo completoAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...
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Regulatory Affairs Specialist
hace 5 días
madrid, España IQVIA A tiempo completoIQVIA 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....
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Regulatory Affairs Specialist — Spain
hace 7 días
madrid, España IQVIA A tiempo completoA 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...
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Senior Regulatory Affairs Specialist
hace 7 días
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 5 días
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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Regulatory Affairs Specialist
hace 3 semanas
Madrid, España EPM Scientific A tiempo completoWe'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...
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madrid, España Indero (formerly Innovaderm) A tiempo completoA Contract Research Organization seeks a Regulatory Affairs Specialist for Spain. The role involves preparing regulatory documents, coordinating timelines for submissions, and ensuring compliance with EU standards. Ideal candidates will possess a scientific bachelor's degree and 2-3 years of clinical research experience, specifically in regulatory affairs....
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Home-based Regulatory Affairs Specialist — CTIS
hace 7 días
madrid, España Indero A tiempo completoA contract research organization is seeking a Regulatory Affairs Specialist in Madrid. The role involves preparing and submitting regulatory documentation, ensuring compliance with EU regulations, and coordinating timelines for clinical trial submissions. Candidates should have a Bachelor's degree in a scientific discipline and 2-3 years in regulatory...
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Regulatory Affairs Specialist
hace 7 días
Madrid, España Indero A tiempo completoDue 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 contractual...
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Regulatory Affairs Specialist
hace 4 semanas
Madrid, España EPM Scientific A tiempo completoWe'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...
