Contract Regulatory Jobs
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Medical Writer Regulatory
U.S.-based medical device company at the final stages of our clinical program and preparing for a 510(k) submission. We are seeking an experienced Medical Writer with a strong background in regulatory writing for medical devices, specifically 510(k) and/or De Novo submissions. This is a contract role requiring full-time availability for the next co...
QARA Consultant
We are seeking a QARA Consultant to support cross-functional teams in the development, manufacturing, and regulatory submission of combination products. Key Responsibilities:Provide regulatory and quality guidance on combination products, particularly those involving drug-device interactions.Support US regulatory specialists in the preparation and ...
Medical Writer Regulatory
EPM Scientific is partnering with a leading global pharmaceutical company that is experiencing a surge in regulatory activity due to an exciting pipeline of new products. To support this growth, we are seeking experienced Regulatory Writers on a freelance basis.Freelance Regulatory Writer - Global Pharmaceutical CompanyContract Length: 12 MonthsCom...
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Regulatory Strategist with Digital capabilities
Main responsibilitiesAs a key member of the Global Regulatory Team, the Regulatory Strategist (RS) is the strategic partner to contribute to the definition of the global regulatory strategy for assigned products, to enable and drive its execution in US, EU and worldwide countries, including Health Authority interactions.The Regulatory Strategist wi...
CMC, Process Validation
A biotech company is seeking an experienced leader to oversee late-phase clinical manufacturing of biologic's at external partners. This role involves managing internal project teams and acting as the primary liaison with CDMOs, ensuring successful tech transfer, process validation, and regulatory readiness for live bacterial vaccine products.Key R...
Regulatory Consultant
We are looking for an experienced and detail-oriented Regulatory Affairs Consultant to join our team on-site in Denmark. This role is ideal for someone with a strong background in medical device regulations who thrives in a collaborative, fast-paced environment. You will play a key role in ensuring compliance with EU MDR and other global regulatory...