Regulatory Affairs Specialist: Oncology

Job DescriptionAn amazing opportunity has arisen for a Regulatory Affairs Specialist to join our Regulatory Affairs team in Spain. In this role, you will be part of an experienced and talented team responsible for the regulatory lifecycle management of our assigned product portfolio in Spain, with a dedicated focus on the therapeutic areas of Oncology and...

We are seeking an experienced and proactive Regulatory Affairs Specialist to join our team. In this role, you will be responsible for preparing, compiling, and submitting technical documentation to secure and maintain global market access for our medical device portfolio. You will collaborate cross-functionally with R&D, Quality, and Clinical teams to...

EU Regulatory Strategy and Project Management Serve as the primary regulatory and scientific point of contact with the European Medicines Agency (EMA), national competent authorities in EU Member States, internal stakeholders, customers, consultants, and vendors. Develop and implement EU regulatory strategies and action plans in alignment with the...

Medicine moves forward here. So willyou.Ergomedis a specialist clinical research organization focused on rarediseaseand select oncology indications. We focus on the most complextrials,the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move...

Henry Schein is seeking a Senior QA/RA professional to support EMEA-wide quality and regulatory operations, document EMEA policies, and manage CAPA follow-up, reporting to the Snr.Director QA/RA EMEA.The role is remote, based in Spain or Germany, with up to 30% travel.Key duties include audits, change control oversight, eQMS maintenance, GDP/MDR compliance,...

Kelly is seeking an experienced Regulatory Affairs Specialist to drive global market access for its medical device portfolio. You will compile technical documentation and manage submissions under EU MDR and FDA requirements, while collaborating with R&D, Quality, and Clinical teams to ensure regulatory compliance.You will coordinate with Notified Bodies and...

Ergomed Group is a specialist clinical research organization focused on rare disease and select oncology indications, with global presence and a collaborative culture. The Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities related to achieving site initiation readiness and regulatory compliance.Role requires a graduate...

Clinical Development Director - OncologyCareer Category Clinical Job DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since ****, we've helped pioneer the world of biotech in our...

Precision for Medicine is a global Clinical Research Organization with uniquely integrated offering which enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in...