Trainee - Regulatory Operations (Rims)
2 days ago
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Regulatory Operations Trainee on a permanent basis. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies. Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career **Main Job Tasks and Responsibilities**: - Perform the required Data Clean-up as per the defined process into Regulatory Information Management System (RIMS). - Complete the assigned user requests on daily basis, as per the defined process. - Communicate with Business Users for any queries related to user requests. - Collect information from different sources and locations (manual and electronic) including any supporting reports. - Enter the collected information manually in RIMS for storage and analysis. **The Application Process**: **Who will you be working for?** **About ClinChoice**: ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare **Our Company Ethos**: Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. **Key words**: Regulatory Operations Trainee, Junior Regulatory, Regulatory Affairs, Regulatory Operations, Reg Affairs, Regulatory Information Management System, RIMS, CRO, Contract Research Organisation
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Regulatory Affairs
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Bengaluru, India vueverse. Full timePosition Overview:We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includes Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key responsibilities:Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global...
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