Regulatory Specialist- CTA

As the Regulatory Operations Specialist for the assigned specialty programs (NCE/BLA), your primary role will involve handling various regulatory operations activities. This will include CTA applications in EU, LATAM, USA, Canada, and ROW, CTIS management, submission management, eCTD publishing of all modules, and document management. It is crucial for you to have a thorough understanding of current Global Regulatory filing requirements and eCTD/CTIS structure. Your responsibilities will also include collaborating with Strategists (Leads) and coordinators to develop submission strategies and timelines. You will be responsible for preparing Regulatory Management Plans and Submission content plans for Clinical Trials. Additionally, you will manage the lifecycle of CTAs for both in-house and outsourced activities. As the critical technical coordinator for Clinical Trial Application submissions, it will be your responsibility to ensure accurate and timely input of data, including handling notifications, requests for information, and information requests. Archiving necessary submissions and documents will also be part of your duties. You will assist in defining, developing, and implementing processes to meet the evolving needs of CTIS. Tracking and generating metrics as requested by the Functional Head, implementing best practices, and participating in process improvements/enhancements will be essential aspects of your role. Furthermore, you will support other Regulatory operations activities, such as Clinical Trial Disclosure and eCTD publishing. Qualifications Required: - Bachelor's degree in a relevant field - Previous experience in regulatory operations, specifically in CTA applications and eCTD publishing - Strong understanding of Global Regulatory filing requirements - Excellent communication and coordination skills - Ability to multitask and prioritize effectively - Knowledge of Clinical Trial Application submission processes Please note that the above details are based on the provided job description.,