EU Regulatory

Thermo Fisher Scientific seeks an experienced Regulatory Affairs professional to support EU/EEA regulatory assessments of changes for clinical trial documentation and related CMC activities. The role focuses on coordinating regulatory change control, SoC preparation and interaction with cross-functional teams. The candidate will review SmPCs, labels,...

Mira is a San Francisco-based hormonal health company providing integrative care and hormonal testing for over 300,000 customers. In 2023, we were recognized by Inc. 5000 as America's fastest-growing femtech company. Mira’s breakthrough innovation was creating the market’s only FDA-compliant at-home hormone monitor with quantitative testing technology....

Parexel is seeking a Senior Regulatory Affairs Associate focused on CMC for biologics and vaccines. The role involves post-approval regulatory activities, worldwide submissions, and close collaboration with manufacturing, QA, QC, and regulatory teams to drive submission strategies and risk mitigation. This position supports variations, renewals, and market...

Sei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device ? PQE Group è affermata in questo settore dal 1998 , garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe. Lavorare in una realtà di consulenza come PQE Group ti...

Mira, a fast-growing femtech company, seeks a Regulatory Submission Specialist to lead and support regulatory documentation for in vitro diagnostic devices. You will ensure compliance across technical documentation and regulatory programs while collaborating with internal teams and external consultants. The role emphasizes EU IVDR CE-marking readiness,...

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Parexel is seeking a Senior Regulatory Affairs Associate to drive post-approval regulatory activities focused on CMC for biological and vaccine products. You will collaborate across manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance. Responsibilities include developing post-approval CMC submission...

Mira, a San Francisco-based hormonal health company, seeks a Regulatory Submission Specialist to lead regulatory documentation for IVD devices. You will ensure evidence supports claims, align labeling, and coordinate with internal teams and external consultants to maintain compliance throughout the product lifecycle.The role requires EU IVDR experience,...

Overview In this role you drive regulatory submissions for Italy under the EU CTR, supporting the startup of studies for novel medicines. You will work within regulatory and ethics teams to coordinate packages, communicate with authorities, and ensure timely, compliant documentation. The position blends regulatory expertise with cross‑functional teamwork...