Senior Manager, Global Clinical Regulatory Leader (Remote)

The Senior Manager, Global Clinical Regulatory Leader is responsible for providing strategic and operational direction for regulatory activities of drug products, supporting global clinical trials, regional registrations, and life cycle management. This role involves collaborating with project teams and stakeholders for local product registrations, ensuring compliance with local regulatory requirements and commercial objectives, and providing regulatory support to Global Pharmacovigilance. Key duties include preparing global regulatory strategies, maintaining knowledge of regulations, analyzing development work within global regulatory guidance, preparing CCDS, US-PI, and SmPC documents, and preparing/reviewing various regulatory submissions. Additionally, the role involves initiating and executing CTA/CTNs in the US, EU, and globally, and managing interactions with health authorities and CROs.