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This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. The role...
Lead the safety strategy of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease...
You will play a pivotal role in ensuring the quality and compliance of Investigational Medicinal Products (IMPs) through your leadership and guidance of supplier management teams....
Write and review clinical (and nonclinical) documents for regulatory submissions in the EU and US, such as Module 2.5, 2.7, 2.4, 2.6, integrated summaries of efficacy/safety...
The role will provide leadership and strategic direction for assigned programs, ensuring the successful implementation of the quality strategy and/or quality plans to foster a...
Are you an experienced Regulatory Affairs leader with a passion for medical devices? Are you looking for a motivated and diverse department to empower, guide and mentor Applied...
Work with country or global teams to plan and implement Phase IV GMA-sponsored clinical trials, interventional or non-interventional. This includes all aspects of study management...
Contribute to study protocol development including study concept, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate,...
Lead (Co-lead) the study teams to develop a cross-functional, integrated study implementation plan including creation of initial study budget, study kick-off and team meetings....
A managerial position responsible to ensure that assigned Quality Management System activities are managed in compliance with regulations and company policies and in accordance...
The core responsibility of the Medical Director is to lead the local medical department, be a part of pan-European R&D projects and work closely with other medical departments in...
You will oversee the execution of one or more clinical trials across different therapeutic areas and development stages, ensuring high-quality and timely deliverables. Participate...
Ensure compilation, submission and approval of CTAs and INDs for all clinical trial-related regulatory activities, maintaining these throughout the development phases. Provide...
Lead the safety profile of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease...
This position is responsible for working with the physicians and other clinical scientists within Early Clinical Development to provide clinical research support for early phase...