Job Purpose As a Senior Manager, Regulatory Affairs CMC, you are an integral part of MoonLake’s Clinical Development.... You will be responsible for the development of a CMC and device regulatory strategy, working closely with Technical Operations colleagues. The...
MoonLake Immunotherapeutics, Switzerland, and the UK. In this role you will need to provide provide regulatory strategy, leadership, and operational support... strategy for development or marketed products, taking in consideration the latest precedent, regulatory intelligence, agency...
Gileadagencies (FDA, EMA) to support clinical trial regulatory submissions Liaise with other functions to enable quality clinical..., MA) The Clinical Development Lead will primarily focus on study design strategy for the development of clinical study...
Philipsclinical safety assessments and regulatory reports/submissions involving safety information. Experience working with vendor... close collaboration with the safety vendor to ensure appropriate case processing. Contribute to regulatory authority submissions...
MoonLake Immunotherapeuticsthe clinical and health economic value of some of the newest and most innovative therapies in development Salary... the division you will work on the successful delivery of projects to demonstrate the clinical and health economic value...
Costello MedicalRole summary Responsibilities: You will work on the successful delivery of projects to demonstrate the clinical... to demonstrate the clinical and health economic value of some of the newest and most innovative therapies in development. In...
Costello Medicalsubmissions, responses to regulatory agency inquiries, pharmacovigilance (PV) processes and projects, and PV or other audits... experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment, including...
Gilead