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 you’re 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.