Regulatory Affairs Manager job in Johannesburg | CareerJunction × Location In All Categories Share This Job Regulatory Affairs ManagerMVG Recruitment Specialists UndisclosedPermanent Specialist EE positionJohannesburgPosted 27 Nov 2023 by MVG Recruitment SpecialistsExpires in 33 daysJob 2546841 - Ref MP/RAM Save Apply Now About the positionRegulatory Affairs ManagerIndustry: PharmaceuticalLocation: JHBEquity Requirement: EELead 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 experienceKey CompetenciesExperience 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/RAMSupporting 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 Apply Now MVG Recruitment Specialists View agency profile See all MVG Recruitment Specialists jobs About the agencyHeadquartered in Cape Town.Medical and Pharmaceutical Recruitment Specialists; Specialising in the placement of pharmacists, pharmacist assistants, nurses and technical staff into all areas of the medical/pharmaceutical industry nationally in South Africa. APSO Registered.LEVEL 1 BBBEE Certified EMAIL ME JOBS LIKE THIS Share This Job RECOMMENDED JOBS FOR YOU New Regulatory Affairs Compliance and Artwork Officer MVG Recruitment Specialists Permanent Specialist EE position Johannesburg Expires in 33 days New Enterprise System Specialist talentCRU Permanent Management position Johannesburg Expires in 33 days SAP Sales & Distribution at Accenture Accenture Permanent Intermediate position Midrand Expires in 28 days HR Business Partner Staff Unlimited Permanent Intermediate position Johannesburg Expires in 15 days Compliance Officer at GG Recruitment GG Financial Recruitment Permanent Intermediate position Randburg Expires in 7 days SAP FI Functional Lead at Accenture Accenture Permanent Intermediate position Midrand Expires in 27 days Regulatory Affairs Manager
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