Job Description

Regulatory Affairs Specialist M/F - South AfricaFull job descriptionAbout the jobIn the context of our growing activities, we are looking for a Regulatory Affairs Specialist M/F to join our teams in South Africa.You will integrate a team of Regulatory Affairs professionals dedicated to one of our new main clients across the globe and will have the mission to develop PLGxe2x80x99s local South Africa Regulatory Affairs presence, taking responsibility for new regulatory activities related to South Africa for this main client and other several clients.ResponsibilitiesRegulatory in country affiliate activitiesLocal stakeholder interfaceOperational liaison with 3rd PartiesRegulatory Assessment for Quality and Safety changes (including labelling updates and non CMC administrative changes)Creation/update of Country Label DeviationUpdate and approval of local artworksProvision of local regulatory intelligenceUpdate of local site licenses (GMP site renewals)Regulatory review of local promotional materials via PromoMatsLocal Regulatory SOP review and updateRegulatory activities for new launches (preparation of Marketing Authorization Applications)Coordination of Response to QuestionsPreparation/update Product InformationPreparation /update local abbreviated PI (if applicable)Fee calculationPreparation of Renewal Procedure (eg. local document identification and preparation)Preparation for Variations including. RtQs, requesting/securing centrally provided documentationPreparation and submission of Technical/Site Transfer ApplicationsRegulatory support in relation to local requirements relating to cessation of marketing / sunset clause / withdrawal of MAsAssisting with license applications as required.Responding to internal requests for technical and/or regulatory information.Providing support during external and unannounced audits.Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.General regulatory administration duties and compliance requirementsPreparation for Annual Safety Updates/HA instructed safety updatesInforming reliant markets of changes to reference productPQR local submissions (when applicable)Responding to requests from Medical information (when applicable)Provision of regulatory data for PV reportingUse a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etcEducationAt least a Bachelorxe2x80x99s Degree in Life Sciences, ideally a Pharmacy DegreeExperienceAt least 5 years of experience in RA in a Pharmaceutical Company or Service ProviderSouth Africa LifeCycle Maintenance (LCM) experienceExperience in the management of artwork generation/ labelling/creation/update of product information (at least 3-5 years)Experience in project managementExperience in the new registrations of drug products is preferableExperience of Pharmacovigilance (PV) would be beneficialExperience of promotional/non-promotional activities would be an advantage (at least 3-5 years)SkillsHard/Technical skills:Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations) in South Africa and ideally in the EU regionKnowledge of South African regulation for pharmaceuticals (NCE, Biologicals and Biotech) and ideally for Medical Devices, Combination products and CosmeticsStrong computer skills, including MS Office applications, data and document management systemsFluency in Afrikaans and EnglishSoft skills:Excellent communication skillsExcellent organizational and interpersonal skillsVery good coordination skillsA proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budgetAbility to work well within a team and autonomouslyAbility to prioritize different workloads/multi-taskProcess orientated with good attention to detailSolution-drivenAbout usProductLife Group provides world-class regulatory outsourcing and consulting services for the global life sciences industry. Headquartered in Paris, ProductLife Group has offices in countries across Europe, the Middle East, Asia, Africa, Latin America, and North America.ProductLife Group was founded in 1994 and has since become a global industry leader, thanks to the firmxe2x80x99s driven and talented employees, who are always motivated by a supportive team environment as well as opportunities to learn and to grow professionally. Employees and company partners are located in offices worldwide to support clients and drive continued growth.If youxe2x80x99re enthusiastic, if you welcome challenges, and if you want to grow professionally with a management team committed to your development, apply to join us.

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