About this role
A leading pharmaceutical company has a vacancy for a Senior Regulatory Pharmacist. Key Responsibilities Prepare, compile, review, and submit regulatory dossiers for new product registrations, renewals, and variations. Manage the lifecycle maintenance of registered pharmaceutical products. Liaise with national regulatory authorities regarding product registrations and regulatory queries. Interpret and implement changes in pharmaceutical legislation and regulatory guidelines. Review labelling, package inserts, promotional materials, and artwork for regulatory compliance. Provide regulatory support to Quality Assurance, Manufacturing, Medical Affairs, Marketing, and Supply Chain teams. Maintain regulatory databases and document management systems. Develop regulatory strategies to facilitate timely product approvals. Coordinate responses to regulatory authority questions and deficiency letters. Support inspections and audits conducted by regulatory agencies. Mentor and supervise junior regulatory pharmacists and regulatory officers. Participate in cross-functional project teams for product launches. Ensure compliance with Good Regulatory Practices (GRP), Good Manufacturing Practice (GMP), and company quality systems. Prepare and submit regulatory dossiers, permit applications, renewals, variations, and other regulatory filings through SAHPRA's electronic submission portals, ensuring compliance with current regulatory requirements and timelines. Skills Strong analytical and problem-solving skills. Excellent written and verbal communication. Regulatory writing and technical documentation. Project management. Attention to detail. Time management and prioritization. Leadership and mentoring skills. Stakeholder management. Negotiation and influencing skills. Competencies Regulatory expertise. Ethical decision-making. Strategic thinking. Risk assessment. Customer focus. Collaboration. Accountability. Continuous improvement. Decision-making under pressure. Qualifications Bachelor of Pharmacy (BPharm) or equivalent pharmacy degree. Registration as a pharmacist with the relevant national pharmacy council. Postgraduate qualification in Regulatory Affairs, Pharmaceutical Sciences, or related field (desirable). Typically, 5–8 years of pharmaceutical regulatory affairs experience. Proven experience with pharmaceutical product registration and lifecycle management. Experience interacting with regulatory authorities. Experience preparing CTD/eCTD submissions. Experience with prescription medicines, over-the-counter products, and/or biologics (depending on company portfolio). Candidates that meet the criteria may apply via this portal or via www.mnarecruitment.com Should you not receive feedback within 7 days, please accept your application as unsuccessful