Global Regulatory Affairs Manager

No visa or accommodation sponsorshipYou will be responsible for regulatory activities required at a country level for pharmaceutical products, including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval etc. ensuring regulatory compliance in the applicable market(s) As part of the IQVIA Global Regulatory Affairs department, you will be working with our clients – global pharmaceutical companies. JOB OVERVIEWManage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countriesSubmit submissions such as renewals/ variations/ new applications filings/ MAH transfers to the local Health Authority and EMA and follow up on the local regulatory approval process for designated countriesPreparation of local Product Labelling (e.g. SmPC, PIL), in local language for designated countriesArtwork review and approval in client systemsManage multiple pharmaceutical productsAct as subject matter expert in regulatory processesActs as a Regulatory Team Leader on more complex projects, which may include authoring of regulatory documentation, filling application forms. Establishes relationships with customers; may meet face to face to discuss regulatory issues, present lessons learned and discuss customer commentsActs as a Subject matter expert in Regulatory knowledge in Chemistry, Manufacturing and Controls or Lifecycle Maintenance / Marketing Authorization Transfers/ Labeling/ Publishing. Project budget managementGive guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and developmentpossible exposure to present to clients on complex regulatory processes bid defense meetingsAct as reviewer for regulatory standard operating proceduresPrepare and deliver internal regulatory training if requiredMINIMUM REQUIRED EDUCATION AND EXPERIENCEExperience Typically requires 8-10+ years of prior relevant experience. Education Master's Degree in Life science or related disciplineSkills and AbilitiesGood understanding of the Research and Development process (Chemistry, Manufacturing & Controls) relevant regulatory guideline related guidelines Possesses a specific regulatory or technical expertise Interpersonal communication (oral and written) and organization skills Ability to establish and maintain effective working relationships with coworkers, managers and clients Demonstrates self-motivation and enthusiasm Ability to adapt quickly to a rapidly changing environment Knowledge of Maintenance of marking Authorization Experience of preparing variation, renewal packages and artwork approvals. Fluent in English language and able to effectively communicate complex business language to those who speak English as a second language. Must be fluent in Arabic #LI-RemoteIQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.comIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.