This listing was posted on Manatal ATS.
Associate Regulatory Professional II
Location:
Bengaluru
Description:
The position As Associate Regulatory Professional II, you will play a crucial role in driving, coordinating, and actively following up on multiple tasks with challenging timelines. Your responsibilities will include: Working closely with various submission teams across the organization and all countries in Europe. Managing initial clinical trial application submissions in the EU according to the Clinical Trial Regulation (EU CTR) and all changes during the life cycle of clinical trials. Maintaining documents (uploading and QC) in the Clinical Trial Information System (CTIS) and ensuring accurate data about clinical trials. Coordinating responses for requests for information from Health Authorities and Ethics Committees. Ensuring timely submissions in CTIS and contributing to project team decisions. Shaping the future setup of new processes for submitting Clinical Trial Applications (CTAs) in the EU. Collaborating with different IT platforms, such as Veeva Vault RIM and Vault Clinical (COSMOS). Qualifications We expect you to have: Bachelor´s degree, masters degree, or Ph.D. in science, pharmaceutical or health science. At least 3+ years of experience in regulatory affairs or clinical trials. Fluent written and spoken English. Vault RIM and Vault Clinical (Veeva platforms) knowledge would be an advantage. On personal level : Strong team player. Well organised, structured, and detailed oriented Have solid problem-solving capabilities. Can keep your spirits high even when under pressure. Skilled communicator who can cooperate at any organisational level. Curios and like learning new things. You love data and working in systems. Enjoy working with people online and want to be part of virtual multi-cultural team. Please use the below link for job application and quicker response. https://lifelancer.com/jobs/view/0e670c23f54a144302958045c02349a8
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More About this Listing: Associate Regulatory Professional II
Associate Regulatory Professional II is a Jobs Associate Regulatory Profes Job at Lifelancer located in India. Find other listings like Associate Regulatory Professional II by searching Oodle for Jobs Associate Regulatory Profes Jobs.
Associate Regulatory Professional II is a Jobs Associate Regulatory Profes Job at Lifelancer located in India. Find other listings like Associate Regulatory Professional II by searching Oodle for Jobs Associate Regulatory Profes Jobs.