Regulatory Affairs Portfolio Lead - Prescription Midrand

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

Requirements

• Bachelor's degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council.
• 3 - 5 years' experience in Regulatory Affairs, preferably in orthodox, human medicines.
• Demonstrable experience across the product development, commercialization and maintenance lifecycle.
• Sound project management capabilities.
• Proven ability to consistently deliver to quality, time and cost standards.