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Lead the safety profile of the assigned product(s) during clinical development including Company Sponsored studies, Investigator Sponsored studies, Compassionate Use and Disease...
Provides global regulatory leadership of assigned program(s); Develops global regulatory strategies, including risk assessment and mitigation strategies; Participates in strategic...
Ensure clinical trials are executed according to protocol requirements, trial plans, OGSM, argenx procedures, ICH-GCP, and other applicable regulations. Set expectations...
Developing and maintaining an expert understanding of the safety profile of the assigned products as well as understanding of the relevant strategic context (e.g disease under...
Serve as scientific expert and pharmacovigilance resource to external and internal partners within the region; Assess current processes to ensure adherence to local/regional safety...
For ensuring corporate compliance with all applicable laws and regulations and as appropriate, local and foreign regulatory reporting requirements and for signal detection,...
The candidate will provide project and operational management, quality guidance and support, whilst working with the team to ensure that all projects are managed within the scope...
Implementing and maintaining pharmacovigilance activities and associated quality management system at the national level including oversight of such activities in other Hub...
This role will be pivotal in integrating quantitative methods to advance the development of innovative therapeutics, including small molecules, antibodies, and antibody-drug...
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...
Providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials. Additionally, this role acts as the Medpace...
The position leads the Global Development Team for the Asset and works in partnership with other global asset functions in accordance with Target Product Profiles (TPP) as jointly...
Accountable for external PV vendor development and oversight, including quality, performance and compliance of cases, support budget review and strategies of tasks outsourced to...
You'll play a crucial role in managing compliance with evolving regulations like REACH, offering a challenging yet rewarding professional environment. In detail, you will...
Provides operational expertise, strategic insights, and cross-functional leadership that enables the delivery of assigned trials within quality standards, agreed upon timelines and...
The right candidate plays a key role in the execution of country medical affairs plans and tactics and delivers regional/national clinical, scientific and technical educational...
As our new Associate Director/Director, Global PV Operations you will become responsible for PV Operations activities and provide strategic and operational PV/quality/safety...
Establish the EMEA regulatory strategy for marketed and pipeline products and ensure it is in line with the global regulatory strategy, taking into account the diverse needs of the...
Develop and implement regulatory strategies for successful product approvals; Provide strategic guidance to cross-functional teams on regulatory requirements and risks Ensure...