Regulatory Affairs ManagerMVG Recruitment SpecialistsUndisclosedPermanent Specialist EE positionJohannesburgPosted 27 Nov 2023 by MVG Recruitment SpecialistsExpires in 33 daysJob 2546841 - Ref MP/RAMAbout the positionRegulatory Affairs ManagerIndustry: PharmaceuticalLocation: JHBEquity Requirement: EELead the Regulatory team and 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 timely processing of regulatory applications.Key Responsibilities:Manage work streams for and report on the assigned group of portfoliosAssist with internal product queries from relevant departmentsAssist with external product queries from the SAHPRA, other MRAs, and third-party stakeholdersReview regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standardsCoordinate and submit new product applications in South Africa and other applicable territoriesDevelop 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, with demonstrated experience across the product development, commercialization, and maintenance lifecycleExperience in use of CTD software builder and compilation of eCTD applications will be an advantageSound project management capabilitiesProven ability to consistently deliver to quality, time, and cost standardsProfessional people management experienceKey Competencies:Leadership skills and management of personnel resourcesAbility to prioritize 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 CouncilDesired Work Experience:5 to 10 yearsDesired Qualification Level:Degree
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