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Medicines Registration Officer: Biological Medicines

Vacancies with Collen
Pretoria
On-siteZAR 562,800 - 919,200 / year

About this role

Medicines Registration Officer: Biological Medicines

The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines Regulatory Authority established in terms of the Medicines and Related Substances Act, 101 of 1965, as amended, to monitor, evaluate, regulate, investigate, inspect, register and control medicines, schedule substances, clinical trials and medical devices, including IVDs, and related matters in the public interest.

Organisation SAHPRA Unit Pharmaceutical Evaluation Management (PEM) Location Pretoria Position Medicines Registration Officer: Biological Medicines Ref No SAHPRA 36 of 2026/27 Salary R 562 800.00– R 919, 200.00 per annum (TOTAL COST TO COMPANY) (Level 1 – Level 2) Market-related salary will be determined by the years of experience obtained

Job Purpose The Medicines Registration Officer for Biological Medicines will be responsible for evaluating and assessing the quality, safety and efficacy of Biological Medicines before they are registered in accordance with the Medicines and Related Substance Act.

Responsibilities

  • Evaluate new biological medicines applications and peer review new applications,
  • amendments and feedback.
  • Evaluate and assess the quality, safety and efficacy of new applications before Biological
  • Medicines are registered.
  • Evaluate and assess applications for amendments of quality, safety and efficacy standards of
  • registered Biological Medicines.
  • Evaluate applicant responses and variations regarding registrations and/or registration of
  • Biological Medicines.
  • Conduct consultation meetings for pre-registration of Biological Medicines.
  • Develop and update guidelines and/or Standard Operating Procedures as required.
  • Participate in pre-registration consultation meetings with manufacture.
  • Ensure continued compliance with Quality, Safety and Efficacy (QSE) and regulatory
  • standards.
  • Lot release functions for Vaccines.

Requirements

  • Applicants must possess a Matric certificate and a relevant four-year Bachelor of
  • Pharmacy or Biological Sciences or Biochemistry or Microbiology degree from a
  • recognised university or tertiary institution at NQF Level 8 as recognised by the South
  • African

Qualifications

  • Authority (SAQA) or Honours degree in related health sciences at

  • NQF Level 8 as recognised by SAQA.

  • Registration with the South African Pharmacy Council (SAPC) for a Bachelor of Pharmacy

  • degree

  • A postgraduate qualification in Biochemistry, Vaccinology, Pharmacology or equivalent

  • and experience in biological medicines registration is an added advantage.

  • Postgraduate studies in Human Molecular Biologist, Immunology or Human Genetics will

  • be an added advantage.

  • Level 1: A minimum of three (3) years’ experience within a pharmaceutical environment

  • or related medicines regulation, medicine production quality assurance, in biological

  • medicines registration or within vaccine release environments.

  • Level 2: A minimum of five (5) years’ experience within a pharmaceutical environment or

  • related medicines regulation, medicine production quality assurance, in biological

  • medicines registration or within vaccine release environments.

  • A valid driver’s licence.

  • Competencies and Skills

  • Knowledge and application of the Medicines and Related Substances Act, 101 of 1965, as

  • amended, and its related Regulations and guidelines.

  • Knowledge of the technical aspects for the evaluation of the quality, safety and efficacy of

  • biological medicines.

  • Ability to meet tight deadlines and manage multiple, often competing, priorities.

  • Must be computer literate and have a sound working knowledge of computer software

  • packages.

  • Understanding of technical and scientific aspects of medicine regulation.

  • Evaluation of guidelines as prescribed by the relevant regulatory authorities.

  • Planning and organisational skills.

  • Leadership skills.

  • Co-ordination skills.

  • Written and verbal communication skills.

  • Diversity management.

  • Time management.

  • Good telephone etiquette.

  • Supervisory skills

  • Due to large number of applications anticipated, communication will be limited to short-listed

  • candidates only. Applicants who have not been contacted within three (3) months after the

  • closing date should consider their application unsuccessful.

  • Interested candidates who meet the above requirements should submit their

  • applications, clearly indicating the title of the position and the reference number.

  • Applications must include a signed cover letter, a detailed Curriculum Vitae (CV) with the

  • names and email addresses of three (3) referees, and copies of the required qualifications

  • (including matric). Only shortlisted candidates will be required to submit certified copies

  • of qualifications and other relevant documents on or before the interview date, as

  • communicated by Human Resources.

  • Should you have a foreign qualification, your application must be accompanied by an

  • evaluation certificate (report) from SAQA.

  • Incomplete applications or applications without the aforementioned documents or

  • information will not be considered.

  • The above-mentioned documents are compulsory. Incomplete applications or applications

  • without the aforementioned documents or information will not be considered.

  • No late applications will be accepted. Any submissions received after the specified date and

  • time will not be considered, and CVs will not be returned.

  • Shortlisted candidates will be expected to attend selection interviews on a specific date,

  • time, and location as communicated by SAHPRA.

  • Applicants should note that pre-suitability checks will be conducted after they have been

  • shortlisted. The appointment is subject to positive outcomes from these checks, which

  • include security clearance, verification of qualifications, criminal records, credit checks

  • (where applicable), citizenship status, employment verification and work experience.

  • SAHPRA reserves the right not to appoint any candidate to the advertised post.

  • SAHPRA adheres to the provisions of the Protection of Personal Information Act (POPIA), 4

  • of 2013. CVs will not be returned, as the personal information you provide will be used

  • solely for recruitment purposes, specifically for the position or vacancy you have applied

  • for. If your application is unsuccessful, your personal information will be retained for

  • internal audit purposes.

Employment Equity statement:

  • SAHPRA is committed to being an equal opportunity employer. When filling vacant

  • positions, the entity will consider the principles outlined in Section 195(1)(i) of the

  • Constitution of the Republic of South Africa, Act 108 of 1996, and the Employment Equity

  • Act, 55 of 1998.

  • People with disabilities (should indicate their disability status), males (all races) and

  • females (Coloured and White) will be given preference.

  • Application closing date: 21 October 2026 Applications should be submitted through the SAHPRA Website Online Portal:

  • http://www.sahpra.org.za/vacancies

  • NOTE: SAHPRA WILL NOT ACCEPT APPLICATIONS SENT THROUGH EMAIL ADDRESSES.

  • Enquiries

  • Name Mr Tshepo Khunou, HR Business Partner,

  • Email/ Tel No Tshepo.

  • [email protected]/012 501 0386

  • Click here to apply

  • We wish you all the best with your applications

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