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 that all pharmaceutical, manufacturing, quality, regulatory, storage, and distribution activities relating to vaccine products are conducted in compliance with applicable legislation, GMP requirements, 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 affecting the pharmaceutical industry in South Africa

Provide continuous professional supervision of the manufacturing facility in accordance with SAPC requirements

Ensure compliance with 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

Ensure secure handling, storage, and accurate recordkeeping of medicines and scheduled substances

Supervise pharmacy personnel and ensure appropriate registration, competence, and scope of practice

Manage regulatory inspections, audits, complaints, recalls, and mandatory reporting

Exercise independent professional judgement to protect public health, product quality, and legal compliance

 

Bachelor of Pharmacy (B.Pharm) (NQF Level 8)

Registered Pharmacist with the South African Pharmacy Council (SAPC)

5 years’ experience in Regulatory Affairs within the pharmaceutical industry of which 2 years should be as Responsible Pharmacist within the pharmaceutical industry

Sound knowledge of SAHPRA regulatory processes, GMP, and pharmaceutical legislation

Experience with regulatory submissions, renewals, facility compliance, and post-marketing activities

Strong ability to interpret scientific data and apply it to regulatory and quality compliance

Proven ability to manage multiple projects and regulatory responsibilities concurrently

Proven analytical and problem-solving abilities

Keen attention to detail

Advanced communication (verbal)

Strong technical documentation skills

Highly self-motivated and directed

Ability to work in a team-oriented, collaborative environment

Advanced computer skills

Good interpersonal skills

Ability to effectively prioritize and execute tasks in a high- pressure environment.

Time management.