Pharmacist

BUSINESS UNIT: SOUTH AFRICAN VACCINE PRODUCERS

DISCIPLINE: SAVP

LOCATION: SANDRINGHAM, JOHANNESBURG

POSITION: REGULATORY AFFAIRS PHARMACIST

PAY GRADE: D2

REFERENCE NUMBER: CORPSAVP0626/001-01

Key Responsibilities:

■ 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

Minimum requirements & key competencies:

■ 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.

The closing date is 28 July 2026.

Enquiries may be directed to Ndabenhle Ngongoma @ (011) 386 6145 , or e-mail application to Corporate2@nhls.a c.za