Senior Specialist, Regulatory Drug Project Delivery is a pivotal operational and strategic role within the Global Regulatory Affairs department.The primary mission of this role is to lead and project-manage the end-to-end delivery of regulatory submissions (like clinical trial applications, marketing authorizations, and variations) to health authorities globally (e.g., FDA, EMA, MPA) to get life-changing medicines to patients.This is a consulting
Senior Specialist, Regulatory Drug Project Delivery is a pivotal operational and strategic role within the Global Regulatory Affairs department.The primary mission of this role is to lead and project-manage the end-to-end delivery of regulatory submissions (like clinical trial applications, marketing authorizations, and variations) to health authorities globally (e.g., FDA, EMA, MPA) to get life-changing medicines to patients.This is a consulting
The overall purpose of the role is to support pilot plant activities connected to clinical & stability batches, laboratory work, process development and documentation in a GMP-regulated environment.Essential duties and responsibilities:•Support preparation and execution of clinical, pilot and development batches in accordance with established instructions and procedures.•Perform hands-on laboratory and pilot plant work, including material handling, sample
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