Regulatory Affairs Manager (POS24277) Aeroton
Salary R1m to R1.2 mil per annum
Qualifications Bachelor's Degree in Pharmacy.
Diploma in Pharmacy and Registration with the South African Pharmacy Council+-5 years' experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatoryactivities.
Demonstrable experience across the product development, commercialization and maintenance lifecycleSound project management capabilitiesProven ability to consistently deliver to quality, time and cost standardsGood Manufacturing Practices (GMP)Pharmaceutical production experience or exposure to supplement regulatory knowledge. Key Job Outputs Manage work streams for- and report on the assigned portfolio of products:Internal product queries from relevant departmentsExternal 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 toDevelop regulatory strategies and implementation plans for the preparation and submission of new products, with a focus on complementary medicines and medical devices.
Conduct dossier due diligence to ensure all data gaps are addressed, in preparation for dossier call up and registration of complementary medicinesand other human medicines.
Prepare the registration applications for submission to the regulatory authoritiesWork in collaboration with internal and external stakeholders to assess regulator's submissions requirementsEnsure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines for variations (CMC & Labelling), Renewals, Artwork updates etc.
Update and maintain databases, trackers and systems for all regulatory related activities.Quality Management System: Comply with all requirements of Quality Management System to ensure Good Regulatory Practices are maintained.Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.Internal training and mentoring of peers when required.Establish 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.Support activities such as internal audits or regulatory agency inspectionsEnsure alignment of personal and company valuesCore competenciesExperience in use of CTD software builder and compilation of eCTD dossier applications.IT skills including Microsoft OfficeAbility 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
