Clinical Trial Specialist Global Regulatory Affairs
3 weeks ago
**This is what you will do**: Provide operational support for the daytoday execution of clinical trials, following applicable Standard Operating Procedures (SOPs) and regulatory requirementsPrepare Clinical Trial Applications (CTA) and support development of response to Health Authorities questions, working in close collaboration with global regulatory lead and crossfunctional colleaguesAct as primary contact point with CROs and represent regulatory function in the respective study teams responsible Contribute to development and implementation of CTA strategy in line with defined goals Provide input on documents submitted to the Health Authorities, in accordance with relevant CTA guidelines and applicable commitmentsManage other CTA activities, including management of Trial Master File (TMF) maintenance and Quality ControlAccountable for maintenance of compliant regulatory information and applicable tracker for their respective product(s). Identify, drive, and Implement processes to harmonize and improve clinical trial regulatory activities across Alexion portfolioCollaborate within RQA, cross functionally and across the wider AZ organization to review and identify process improvements and opportunities for alignment with AZ GRA clinical trial processesBe assigned as the EU Clinical Trial Information System (CTIS) user for one or more Alexion Clinical Trial Applications. This will include: Coordinating the Clinical Trial Submissions and Notifications through the CTIS, ensuring accurate and timely input of data into the EMA CTIS system.Reviewing and triaging of Requests for Information from Health Authorities through CTIS to relevant cross functional teamsAssist with identification and implementation of processes to meet the evolving CTIS needsRaises, informs and resolves any issues that may impact submission process or timelines within CTISYou will be responsible for: Prepare regulatory submissions and contacts with regulatory agenciesWork collaboratively with the product team to ensure that quality and regulatory standards are considered throughout the product development life cycleContinually monitor the regulatory environment to maintain expertise in regulatory principles, new issues, competitive products, and implicationsPerform regulatory intelligenceSupport the regulatory lead as regulatory representative within crossfunctional teams to provide expert interpretation of relevant laws, regulations, and company policiesAct as EU CTIS Expert for assigned Alexion clinical trials to manage EU submissions, notifications etc.Act as the EU CTIS Subject Matter Expert and mentor others in Regulatory Affairs responsible for performing critical submission activities in CTISContribute to development and update of procedures for documentation management (template, instructions, etc.), EU CTIS requirements and clinical trial regulatory affairs proceduresAbility to understand and interpret regulatory requirements and translate this into concrete propositionsYou will need to have: Bachelors degree or equivalent education in a life science (biology, chemistry, etc.) Initial experience supporting clinical trial activities; experience supporting global clinical trial activities is a plusGood English oral and written communication skills Working knowledge of Agency regulations and industry standards pertaining to regulatory Understanding of context and content of regulatory submissions and drug development processThe duties of this role are generally conducted in an office environment. As is typical of an officebased role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have: 12+ year(s) experience in Regulatory Affairs within the pharmaceutical industry Good communication experience with regulatory agenciesExperience working on rare diseasesAbility to support projects to completion/ experience working in project teams Ability to work in a flexible environment to meet all regulatory requirements and business requirementsGood organizational skillsSome travels might be required#LIHybrid
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