Regulatory Affairs Manager

Key Job Outputs Manage work streams for- and report on the assigned group Co-ordination and submission of new product applications in South Africa and other applicable territories.Ensure 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 valueCore competencies Experience in use of CTD software builder and compilation of eCTD application will be an advantage.IT skillsLeadership skillsmanagement of personnel resourcesAbility 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 valuesQualificationsBachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy CouncilExperience Minimum of 5 years experience in Regulatory Affairs, preferably in human medicines.Demonstrable experience across the product development, commercialization and maintenance lifecycleSound project management capabilitiesProven ability to consistently deliver to quality, time and cost standards