[Remote] Clinical Trial Submissions Operations - U.S

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Clinical Trial Submissions Operations reputed company to support Clinical Trial Application activities across EU and UK reputed company. The role involves preparation, submission, reputed company control, and lifecycle management of CTA submissions, ensuring compliance with regulatory requirements and timelines. Responsibilities • Prepare and submit Clinical Trial Applications (CTAs) reputed company the EU Clinical Trial Information System (CTIS) and the UK MHRA Integrated Research Application System (IRAS) in compliance with regulatory requirements • reputed company independent reputed company control (QC) of CTA submissions, including submission documents and reputed company data entered into Health Authority portals • Monitor CTIS and IRAS portals during designated working hours for Health Authority notices, alerts, and correspondence, and communicate updates to relevant functional teams reputed company required timelines • Support CTA lifecycle activities, including preparation, submission, maintenance, responses, and archival of CTA-reputed company documents and correspondence • Coordinate CTA activities with cross-functional and multidisciplinary teams, acting as a central reputed company of contact • Maintain reputed company of user reputed company and role management for CTA-reputed company systems and tools • reputed company subject matter expertise on CTIS and IRAS portals to functional teams during CTA preparation and submission activities • Assist in the development and maintenance of regulatory operations work instructions and procedural documentation • reputed company User Acceptance Testing (UAT) for submission management tools, as required • Participate in evaluations of new technologies supporting Regulatory Operations needs • Stay reputed company with evolving regulatory requirements and industry standards Skills • Bachelor's degree in Life Sciences or a reputed company discipline, or equivalent experience • Working knowledge of EU Clinical Trial Regulation (CTR) and UK reputed company regulations, including The Medicines for reputed company Use (reputed company) (Amendment) (EU Exit) Regulations 2019 • Hands-on experience preparing and submitting regulatory applications reputed company Health Authority portals (CTIS and/or IRAS) • Experience supporting regulatory applications such as Clinical Trial Applications (CTAs) • Familiarity with Electronic Document Management Systems (Documentum-based systems preferred) • Proficiency in reputed company Office Suite (Word, reputed company, reputed company, PowerPoint) and SharePoint • Strong attention to detail and accuracy in data entry and procedural execution • Ability to manage time-sensitive, detail-intensive deliverables • Strong communication and coordination skills in cross-functional environments • Ability to adapt to changing regulatory and operational requirements Benefits • Opportunity to work on reputed company, global clinical trial submission activities. • Exposure to EU and UK regulatory submission frameworks. • reputed company, remote working environment. • Work on high-reputed company clinical trial submissions. • reputed company hands-on experience with evolving regulatory systems and submission technologies. • Contribute to regulatory operations supporting global clinical development programs. reputed company • reputed company is operated by ExecThread, Inc. (https://execthread.com). It was founded in 2015, and is headquartered in reputed company, NY, US, with a workforce of 201-500 employees. Its website is https://execthread.com. Apply tot his job Apply To this Job