Hey! Let me fetch the job description for you...Regulatory Affairs Pharma - (Pain, Derma, Digestive)Salary: R900k - 1,000k per year Location: MidrandDescription:Senior Regulatory Affairs Pharmacist: Pain, Derma & Digestive (PDD) - POS24325Salary: R950k - R1mQualifications:Bachelors Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council+-5 years experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities.Demonstrable experience across the product development, commercialization and maintenance lifecycleSound project management capabilitiesProven ability to consistently deliver to quality, time and cost standardsGood Manufacturing Practices (GMP)Pharmaceutical production experience or exposure to supplement regulatory knowledge.Key Job Outputs:Manage work streams for and report on the assigned portfolio of productsExternal 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 products, focusing on complementary medicines and medical devicesConduct dossier due diligence to ensure all data gaps are addressed, in preparation for dossier call up and registration of complementary medicines and other human medicinesPrepare 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 guidelinesUpdate and maintain databases, trackers and systems for all regulatory related activitiesQuality Management System: Comply with all requirements of Quality Management System to ensure Good Regulatory Practices are maintainedMaintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industryInternal training and mentoring of peers when requiredEstablish 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 Competencies:Experience in use of CTD software builder and compilation of eCTD dossier applicationsIT skills including Microsoft OfficeAbility 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 values
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