Regulatory Affairs Pharmacist

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.