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IQVIA
,
Reading, Berkshire
Reg Affairs Officer 2 (office or home-based)
Overview
Job Description
IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. PURPOSE Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. Provides regulatory support for assigned projects. RESPONSIBILITIES * Acts as a Regulatory Team member involved in projects, under the guidance of senior staff. * Manages day-to-day workload in collaboration with senior staff, as appropriate. * Prepares and/or reviews regulatory documentation in area of expertise, as appropriate. * Actively participates with internal and external customers and communicates confidently in straightforward matters. * Understands the Scope of Work, and deliverables for a given project. * May prepare slides and background material for meetings under senior guidance and present to clients by phone or in person. * Preparation of submissions including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, CMC authoring and \ or updates as required. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Technical Skills/Experience * 4-5 years regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions) * Preparation of relevant CTD (Common Technical Dossier) documents to support submissions (mainly Module 1), in collaboration with Technical/CMC/Labelling experts * Quality review of technical/ regulatory documents * Interaction with Regulatory Agencies (EU and/or National Agency) * Regulatory strategy and determination of documentation requirements, timelines, budgets * Revision/review of regulatory SOPs, as appropriate * Project management experience - an advantage * Broad experience in preparing international dossiers including APAC regulatory requirements. Soft Skills * Ability to work to tight timelines and manage peaks in workload * Good team player * Good negotiating skills and the ability to identify and resolve issues * Excellent verbal and written communication skills * Excellent computer skills e.g. Word, Excel, data and document management systems * Cultural awareness for global ways of working * Able to act as a mentor to junior colleagues and to assist in their training and development as appropriate Key words phrases are: Post Approval; Variation; Renewal; Referral; change control assessment; regulatory strategy; team work. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Degree in life science-related discipline or professional equivalent plus at least 5 year's relevant experience* (*or combination of education, training and experience) * 4-5 years regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions. Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning.