Job Description

RA Pharmacist Pharmacist ~ Regulatory
Johannesburg - Gauteng - South Africa
Our client in the pharmaceutical industry is seeking a Regulatory Affairs Pharmacist to support both pre-registration and post-registration activities. This role is ideal for a proactive professional who can manage dossier submissions, handle variations, and ensure compliance with health authority requirements while driving regulatory excellence across the business.
Your Responsibilities:

• Perform pre-launch activities to ensure timely submission and registration of new products.
• Complete dossier audits, risk assessments, and due diligence checks to identify and close gaps.
• Compile, screen, and submit new dossiers and regulatory responses in line with guidelines and timelines.
• Support post-registration lifecycle management, including updates, variations, resolutions, and re-launch activities.
• Review and approve product artwork and change control documents.
• Conduct dossier gap analyses to support new product launches and business development projects.
• Track and follow up with health authorities to ensure timely approvals.
• Maintain accurate documentation and databases for all dossiers and correspondence.
• Provide support to Quality Assurance, Medico-Marketing, and Supply Chain teams where regulatory input is required.
• Build and maintain strong relationships with regulatory authorities, industry bodies, consultants, and global stakeholders.
• Stay abreast of regulatory changes and communicate their impact to the business.

Minimum Requirements:

• BPharm, BSc, or higher postgraduate scientific degree.
• Minimum 2 years experience in a regulatory affairs function.
• Knowledge of e-CTD submissions and regulatory guidelines.
• Strong attention to detail, resilience, and time management skills.
• Excellent communication and collaborative approach.
• Ability to work independently and as part of a team.

We are looking for a results-driven professional with strong problem-solving skills, the ability to manage complex regulatory submissions, and a collaborative mindset. If youre ready to take the next step in your regulatory affairs career and make an impact in the pharmaceutical industry, we would love to hear from you.
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