Regulatory Affairs Manager(POS24191)Area:AerotonR1,5 1,7k paLead the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs. To ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications.Qualifications/experienceBachelors degree in Pharmacy/Diploma in PharmacyRegistration with the South African Pharmacy CouncilMinimum of 5 years experience in Regulatory Affairs, preferably in human medicines.Demonstrated experience across the product development, commercialization and maintenance lifecycleSound project management capabilitiesProven ability to consistently deliver to quality, time and cost standardsProfessional people management experience Key Job OutputsManage work streams for- and report on the assigned group of portfoliosAssisting with internal product queries from relevant departmentsAssisting with external product queries from the SAHPRA, other MRAsand 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 territories, including but not limited toDevelop regulatory strategies and implementation plans for the preparation and submission of new productsConduct dossier due diligence to ensure all data gaps are addressed Prepare the registration applications for submission to the regulatory authorities Work in collaboration with NBD 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 industry.Internal 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 enhanced.Manage 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 application will be an advantage.IT skillsLeadership skills, management of personnel resourcesAbility to prioritise and work to tight deadlinesSystems and operations analysisActive 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 valuesClosing date: 14 July 2024
