Hey! Let me fetch the job description for you...Regulatory Affairs Pharmacist - OTCSalary: R750k - 800k per yearLocation: MidrandDescription:Regulatory Affairs Pharmacist OTC POS24203Qualifications/ExperienceBachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council3 to 5 years experience in Regulatory Affairs, preferably in human medicinesDemonstrable experience across the product development, commercialization and maintenance lifecycleSound project management capabilitiesProven ability to consistently deliver to quality, time and cost standardsKey Job OutputsManage work streams for and report on the assigned portfolio of productsAssisting with internal product queries from relevant departmentsAssisting with external product queries from the SAHPRA, other MRAs and third-party stakeholdersEstablish regulatory priorities and allocate resources and workloadsReview regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standardsCo-ordination and submission of new product applications in South Africa and other applicable territoriesDevelop regulatory strategies and implementation plans for the preparation and submission of new productsConduct dossier due diligence to ensure all data gaps are addressedPrepare the registration applications for submission to the regulatory authoritiesWork in collaboration with internal and external stakeholders to assess regulators submissions requirementsEnsure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelinesMaintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industryInternal training and mentoringEstablish and maintain effective relationships with Regulatory Authorities, internal and external stakeholdersFormulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhancedSupport activities such as internal audits or regulatory agency inspectionsEnsure alignment of personal and company valuesCore CompetenciesExperience in use of CTD software builder and compilation of eCTD applicationsAbility to prioritise and work to tight deadlinesSystems and operations analysisBasic cost management skillsActive learningStrategic thinkingAbility to cope with a high degree of complexity and changeCross Functional skills: Ability to network, liaise and negotiate with othersAbility to set standards and objectives and monitor progressComplex problem solving and decision-making skillsCustomer relationshipsDevelopment of peopleMust demonstrate responsibility, excellence and collaboration and align with Company valuesInterested parties who meet the above requirements must email
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