Regulatory Affairs Manager

Reporting to Head: Regulatory Affairs
Job Purpose:
Support 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.
Qualifications/Experience: Bachelor's degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy CouncilMinimum 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 Competencies: Experience in use of CTD software builder and compilation of eCTD application will be an advantageIT 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 values
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