Regulatory Affairs Portfolio Lead - Prescription Midrand

Adcock Ingram Holdings Limited and its Subsidiaries (“we”, “us”) is committed to protecting and respecting your privacy. Our Privacy Notice sets out the basis on which personal information collected inter alia from you, social media, recruitment agencies and our website, will be processed by us. The Privacy notice is available on our website www.adcock.co.za. One of the conditions under the Protection of Personal Information Act 4 of 2013 (POPIA) provides that candidates have the right to be informed about the collection and use of their personal information, In the course of your application: we may collect personal information that may be used to identify potential professional opportunities other than the job you have applied for but of which we think might be of interest to you. use your Personal Information to confirm references or background checks you have provided us. request your consent to participate in aptitude tests or recruitment assessments. We also use your personal information to respond to your inquiries, to verify your information and to share information with you. Your personal information will be securely stored by the Human Capital Department and it will be retained for a period of up to 12 months as of the closure of the application procedure if your application is unsuccessful, and in case of a successful application and you are hired, your data will be transferred to your personal employee file. By applying for this position, you consent to us processing your personal information. We reserve the right to make an appointment. If you have not heard from us within 30 (thirty) days of the closing date, please accept that your application was unsuccessful. Correspondence will be entered into only with shortlisted candidate Job Purpose : To screen, request data, collate and compile the registration dossier, pre-registration and post-registration applications and where applicable any other documentation for submission to the Regulatory Authority. Reporting to : Regulatory Affairs Manager Key Performance areas : Ensure timeous initiation and management of the registration process for new product submissions. Ensure approval of registration applications of all medicines with the relevant authorities: Completes specific pre-registration activities including receipt, screening, compilation and timeous submission of dossier/s to the Regulatory Authority. Ensures that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly in order to enable registrations. Ensures that required standards, protocols and processes around obtaining dossiers and gathering supporting data from suppliers are followed after signing of appropriate agreements. Ensure the maintenance/update of registrations in accordance with the relevant legislation, regulations and guidelines: Receives, prepares and submits all applicable updates, variations, resolutions and any other correspondence required by the Regulatory Authority. Completes dossier audits of Registered Products for the assigned products. Conducts dossier due-diligences, post-registration variations for all applicable Regulatory Authorities in compliance with the latest regulatory guidelines and applicable Regulations within the specified time-lines in order to support the business and strategic company objectives. Establish and maintain effective relationships with Regulatory Authorities: Manages relationships with the Regulatory Authorities to ensure more effective streamlining of the company’s applications when required. Building sustainable relationships with internal and external stakeholders to achieve regulatory goals. Effectively managing, auditing and implementation of Regulatory systems. Prepare, review and adhere to Standard Operating Procedures (SOP’s) and local Regulatory Guidelines. Ensure alignment of personal and company values. Technical Skills/ Compentencies Required : Knowledge of new and emerging Acts, Regulations and Guidelines pertaining to the pharmaceutical industry. Experience in use of eCTD software builder and compilation of eCTD application will be an advantage. Behavioral skills and Attributes : Strong detail, quality and compliance orientation. Sound project management capabilities. Time management. Strict adherence to the timelines. Analytical and problem-solving skills. Self-starter, able to work independently. Able to handle multiple projects simultaneously. Good verbal and written communication skills. Information seeking. Ability to understand stakeholder needs. Sense of urgency. Perform and succeed under pressure. Team player. Adaptability – Able to adapt to changes in the work environment. Closing Date : 23 September 2026