Regulatory Affairs Portfolio Lead

Regulatory Affairs Portfolio Lead (POS25036) MIDRAND
Salary: R1M
Reporting to: Regulatory Affairs Manager
Job Overview: Support the Regulatory Affairs team to provide superior Regulatory services to relevant departments within the company and with external Partners and Principals, and to control and manage a portfolio of product outputs.
To ensure legal and regulatory 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.
Requirements: Bachelors degree in pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council3 to 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 applications.IT skillsAbility 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 valuesClosing Date: 13 February 2025