Regulatory Affairs Manager

QualificationsBachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy CouncilRelevant experience Minimum of 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 standardsCore 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 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 relationships, development of peopleMust demonstrate responsibility, excellence and collaboration and align with Company values