Regulatory Affairs Pharmacist OTC POS24203Based: MidrandSalary: R750KQualifications/ExperienceBachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council3 to 5 years experience in Regulatory Affairs, preferably in human medicinesDemonstrable experience across the product development, commercialization and maintenance lifecycleSound project management capabilitiesProven ability to consistently deliver to quality, time and cost standardsKey Job OutputsManage work streams for and report on the assigned portfolio of products.Assist with internal product queries from relevant departments.Assist with external product queries from the SAHPRA, other MRAs and third-party stakeholders.Establish regulatory priorities and allocate resources and workloads.Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards.Coordinate and submit new product applications in South Africa and other applicable territories.Develop regulatory strategies and implementation plans for the preparation and submission of new products.Conduct dossier due diligence to ensure all data gaps are addressed.Prepare the registration applications for submission to the regulatory authorities.Work in collaboration with internal and external stakeholders to assess regulators submissions requirements.Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines.Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.Conduct internal training and mentoring.Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders.Formulate 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 inspections.Ensure alignment of personal and company values.Core CompetenciesExperience in use of CTD software builder and compilation of eCTD applications.IT skills.Ability to prioritise and work to tight deadlines.Systems and operations analysis.Basic cost management skills.Active learning.Strategic thinking.Ability to cope with a high degree of complexity and change.Cross Functional skills: Ability to network, liaise and negotiate with others.Ability to set standards and objectives and monitor progress.Complex problem solving and decision-making skills.Customer relationships.Development of people.Must demonstrate responsibility, excellence and collaboration and align with Company values.Interested parties who meet the above requirements must email.Closing Date: 25 July 2024
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