Join a distinguished pharmaceutical organization at a pivotal growth stage, where your expertise will be instrumental in navigating complex regulatory landscapes and ensuring product compliance across South Africa's vibrant healthcare sector. This senior Regulatory Affairs Pharmacist role offers a unique opportunity to lead regulatory strategies within a dynamic environment committed to public health excellence.
Duties:
Compile, review, and submit registration dossiers for new and existing products to SAHPRA
Manage post-approval activities including variations, renewals, pharmacovigilance, and post-marketing compliance
Serve as the responsible Pharmacist for South African Vaccine Producers operations, ensuring adherence to legislation, GMP, SAHPRA regulations, and company standards
Ensure regulatory compliance of labelling, packaging, and advertising materials
Provide regulatory strategy and guidance for product development, new product launches, and business growth
Maintain accurate and up-to-date regulatory documentation, databases, and submission records
Monitor and interpret legislative and regulatory changes within the pharmaceutical industry in South Africa
Oversee continuous professional supervision of the manufacturing facility in compliance with SAPC requirements
Ensure adherence to the Pharmacy Act (Act 53 of 1974), Medicines and Related Substances Act, SAPC Rules, and GMP
Oversee quality management systems, SOPs, documentation control, and product release processes
Ensure secure handling, storage, and accurate recordkeeping of medicines and scheduled substances
Supervise pharmacy personnel, ensuring proper registration, competence, and scope of practice
Manage regulatory inspections, audits, complaints, recalls, and mandatory reporting
Exercise independent professional judgement to safeguard public health, product quality, and legal compliance
Requirements:
5 to 8 years' experience in a regulatory or pharmaceutical environment
Strong understanding of GMP, pharmaceutical legislation, and SAHPRA regulations
Excellent communication and project management skills
Proficient in data interpretation and analytical thinking
Ability to manage multiple projects with effective time management
Skills in R and C programming languages
Familiarity with the following:
Quality management systems and SOP development
Pharmacovigilance activities
Regulatory submissions and database management
If you are ready to leverage your expertise to make a significant impact on public health and join a forward-thinking team, we invite you to apply now and take the next step in your career.
