Industry: Pharmaceutical
Location: JHB
Equity Requirement: EE
Lead the Regulatory team and 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.
Key Responsibilities
Manage 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 MRA's and third-party stakeholdersReview 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 productsFormulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Key Requirements
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 medicines. Demonstrated experience across the product development, commercialization and maintenance lifecycleExperience in use of CTD software builder and compilation of eCTD application will be an advantage.Sound project management capabilitiesProven ability to consistently deliver to quality, time and cost standardsProfessional people management experience
Key Competencies
Experience in use of CTD software builder and compilation of eCTD application will be an advantage.Leadership skills, management of personnel resourcesAbility to prioritise and work to tight deadlinesAbility to cope with a high degree of complexity and changeCross Functional skills: Ability to network, liaise and negotiate with othersComplex problem solving and decision-making skills
(Full role profile available on application)
Apply to [Email Address Removed] Subject: MP/RAM
Supporting Documentation Required
Comprehensive CVCopy of Matric CertificateCopy of Pharmacy DegreeCopy of Industry Body Registration (SAPC)
Desired Skills
Bachelor's degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
Desired Work Experience
5 to 10 years
Desired Qualification Level
Degree
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