Regulatory Affairs Manager Gauteng

Regulatory Affairs ManagerReference: DBN003453-SS-4A leading pharmaceutical company has a vacancy for a Regulatory Affairs Manager.Duties & ResponsibilitiesJob Purpose:Lead 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 outputs. 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 stakeholdersEstablish regulatory priorities and allocate resources and workloadsReview 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 to:Develop regulatory strategies and implementation plans for the preparation and submission of new productsConduct dossier due diligence to ensure all data gaps are addressedPrepare the registration applications for submission to the regulatory authoritiesWork in collaboration with NBD to assess regulator's submissions requirementsEnsure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelinesMaintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.Internal training and mentoringEstablish and maintain effective relationships with Regulatory Authorities, internal and external stakeholdersFormulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.Manage activities such as internal audits or regulatory agency inspectionsEnsure alignment of personal and company valuesRequirements: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 standards Professional people management experienceCompetencies:Experience in use of CTD software builder and compilation of eCTD application will be an advantage.IT skillsLeadership skills, management of personnel resourcesAbility to prioritise and work to tight deadlinesSystems and operations analysisActive 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 valuesCandidates that meet the criteria may submit their applications via this portal or via vacancy link on www.mnarecruitment.com. Should you receive no feedback within 7 days, please accept your application as unsuccessful.

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