3.0 - 7.0 years

0 Lacs

maharashtra

On-site

Candidate shall be responsible for assuming the role for the assigned specialty programs (NCE/BLA) and be accountable for regulatory operations activities. This includes, but is not limited to, CTA applications in EU, LATAM, USA, Canada, ROW, CTIS management, submission management, eCTD publishing of all modules, document management, etc. It is essential to have a comprehensive understanding and stay updated with current Global Regulatory filing requirements and eCTD/CTIS structure. You will collaborate with Strategists (Leads) and coordinators for submission strategy and timelines. Moreover, you will be required to prepare Regulatory Management Plan and Submission content plan for CT. The role involves managing the lifecycle of CTA for all in-house and outsourced activities. You will serve as the critical technical coordinator for Clinical Trial Application submission, notification/Request for Information/Information request to ensure accurate and timely input of data. Your responsibilities will also include archival of necessary submissions and/or documents, assisting with the definition, development, and implementation of processes to meet the evolving CTIS needs, tracking, generating metrics as requested by the Functional Head, implementing best practices, and participating in process improvements/enhancements. Additionally, you will support other Regulatory operations activities, such as Clinical Trial Disclosure and eCTD publishing.,

Posted 2 weeks ago

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