Regulatory Affairs Executive at GlaxoSmithKline (GSK)

GlaxoSmithKline (GSK), one of the world's leading research based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. GSK employs over 97,000 employees in over 100 countries worldwide.GlaxoSmithKline Consumer Nigeria Plc is one of Africa's largest consumer healthcare companies, producing leading brands such as Lucozade, Ribena and Panadol.We are recruiting to fill the position below: Job Title: Regulatory Affairs ExecutiveRequisition ID: WD133309Location: LagosFunctional Area: RegulatoryJob Description SummaryThe main reason for the job is to regulate and ensure that the company does not violate any local regulatory regulations as well as maintain the Global GSK requirement for its affiliates.Regulatory Affairs Management maintains the organisation's on-going relationships with regulatory commissions/authorities relating to clinical issues. Ensure compliance as required by regulatory commissions/authorities. Develops programs and processes to manage complaint cases brought to regulatory authorities and develops process improvements to avoid future complaints. Advances organisation positions with internal and external parties. In addition to the line management responsibilities, would be involved in the strategy across therapy areas.Job DescriptionRegistration  and product licence maintenance for the GSK companies as aboveObtain NAFDAC’S approval for adverts for these companiesCo-ordinating destruction exercises within the company and between the company and NAFDAC for all Pharma productsParticipate in company projects from time to timeMonitor and keep in touch with changes in the regulatory environments.Processing  of permits to import and permits to clear for controlled drug products and substances when the need arisesCommunicate effectively with the commercial team of any new developments or changes to products or processes.Ensuring that the premises licences for both GSK Pharmaceutical warehouses were these company products are stored as well as their pharmacists are current for each operating year.Complexity:Need to be able to adapt quickly to constantly changing regulatory policies and environmentAbility to plan and organise workQuick adaptation to continuously increasing responsibilities.Independent Thinking:  Ability to Lobby and get filing documents to avoid delayed product approvalsProactively anticipate issues and get them resolveUse regulatory knowledge to ensure fast product approvals.ResponsibilitiesPrompt processing of registration of products to support the commercial team in timely product launchesPrompt processing of advert materials to meet up the commercial team for product promotionsPrompt attendance to internal artwork/promotional materials approval processCollaboration with other Regulatory team to ensure departmental objectives are achievedAnnual Strategic Planning:This process serves as a guide of what is expected in the next three years from the department and enhances prioritization of product registration.Proactively work out strategy for prompt approvals in the 3/1 plan process 

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