SAHPRA vacancies

To apply, click on the link at the end of the posts and all the best with your applications.

The South African Health Products Regulatory Authority (SAHPRA) is the National Medicines
Regulatory Authority established in terms of the Medicines and Related Substances Act,
1965, (Act No. 101 of 1965) as amended, to provide for the monitoring, evaluation,
regulation, investigation, inspection, registration and control of medicines, scheduled
substances, clinical trials and medical devices, and related matters in the public interest.

Medicine Registration Officer: Clinical Pre-registration Evaluations

Job Type: Permanent

Job Location: Pretoria

Closing Date: 17 January 2025 by 16:00

Salary: R700 105.00 – R888 422.00 per annum (TOTAL COST TO COMPANY)

MEDICINE REGISTRATION OFFICER: CLINICAL PRE-REGISTRATION EVALUATIONS
SALARY: (R 700 105.00 – R 888 422.00) per annum (TOTAL COST TO COMPANY)
(Grade 1 – Grade 2) Market related salary will be determined by the years of experience
obtained post qualification, Internship and Community Service in line with governing
frameworks.

Ref No.: SAHPRA 038/2024
CENTRE: PRETORIA

REQUIREMENTS: Matric certificate and appropriate 4-year Degree in Pharmacy or related
qualification at NQF level 8 as recognised by SAQA and registration with a Professional Body.
A relevant Master’s Degree will be an added advantage. A valid driver’s license.

EXPERIENCE:
Grade 1 – A minimum of two (2) years of clinical experience post Internship and Community
Service. Regulatory experience will be an added advantage.

Grade 2 – A minimum of five (5) years of clinical experience post Internship and Community
Service of which two (2) years should be within regulatory experience.

COMPETENCIES, KNOWLEDGE, AND SKILLS: Knowledge and application of the
Medicines and Related Substances Control Act (101 of 1965), as amended, and its related
Regulations, with respect to the regulation of medicines in terms of quality, safety, and
efficacy. Knowledge of technical aspects for evaluation of quality and efficacy of
bioequivalence of medicines. Comprehensive knowledge and understanding of relevant
legislation, guidelines, protocols, standard operating procedures, and work instructions as
outlined by regulatory authorities. Good planning, organizational and interpersonal skills.
*Self-motivated and able to work independently. Good communication skills (written, verbal,
negotiation, conflict management, presentation). Innovative thinking, initiative, assertive and
leadership qualities. Dedication and accurate work. Ethical behavior. Must be willing to travel
and work irregular hours. Customer service. Planning and organizing skills.

DUTIES: Evaluation of new applications and peer-reviewing of new applications:
Generate evaluation report(s) for each new applications (Generics) in compliance with
required template and adopted regulatory /scientific standards and submit for peer review.
Following peer review process amend the report (s) accordingly to generate a list of queries
to the applicant using the correct templates. *Prepare report for the internal working groups
and where necessary present at advisory committee for complex scientific matters. *Prepare
query letter to the applicant. *Prepare a basis of approval or rejection. *Provide quality
assurance of reports and facilitate resolutions on technical matters. Evaluate applicant
responses for registration/approval of medicines: *Generate second (and subsequent)
evaluation report (s) for each response application and submit for peer review in compliance
with required template and adopted regulatory /scientific standards and submit for peer review.
Peer review other evaluators response reports, according to the required template and
adopted regulatory/scientific standards. *Prepare report for the internal working groups and
where necessary present at advisory committee for complex scientific matters. *Prepare query
letter to the applicant. *Prepare a basis of approval or rejection. *Provide quality assurance of
reports and facilitate resolutions on technical matters. Technical screening for the quality
and efficacy (bioequivalence) aspects of new applications for the registration of
medicines: *Generate technical screening evaluation report(s) for each application. *Prepare
screening query / screening rejection letter to the applicant. *Provide quality assurance of
reports and facilitate resolutions on technical matters. Develop and update guidelines,
SOPs, and templates: *Review existing guidelines, SOPs and templates and update when
necessary. Provide training on guidelines, SOPs, and templates. *Create new guidelines,
SOPs, and templates where SOPs aren’t in place. *Provide regular work-plans and output to
the unit manager (qualitative and quantities report). *Perform any other related duty as
requested by manager/senior manager. Form part of technical working groups or special
projects and provide support to the unit as well as to the Advisory Committees:
Participate in special projects and registration group. *Lead and manage assessments peer
review and discussion working group where relevant. *Compile discussion documents and
reports. *Provide regular trainings to new internal MRO’s and external evaluators. *Take
comprehensive notes of discussions of relevant discussions. *Prepare documents for
SAHPRA management/ RC meeting. Audit and Risk Management: *SOP’s and Guidelines
must be adhered to. *Create and maintain data bases. *Use the most current templates and
guidelines. *Provide and attend relevant training as may be necessary. *Align with QMS
requirements. *Align with ICH, WHO and international standards

INSTRUCTIONS TO APPLICANTS: (HOW TO APPLY): Interested applicants who meet the
above requirements should forward their applications accompanied by signed covering letter
attached to the comprehensive CV with the names and email addresses of three (3) referees
clearly reflecting the name of the position and post reference number, and recently certified
copies of ID, required qualification/s (matric included) and driver’s licence where applicable.

• Applications without the aforementioned documents/information will not be considered.
  Should you be in possession of a foreign qualification, it must be accompanied
  by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable
  where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are
  received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received
  a response from SAHPRA within 3 months of the closing date, please consider your
  application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time
  and place as determined by SAHPRA.

Applicants must note that further checks will be conducted once they are shortlisted and that
their appointment is subject to positive outcomes on these checks, which include security
clearance, qualification verification, criminal records, credit records, citizenship status and
previous employment. All shortlisted candidates will be subjected to a technical exercise
that intends to test relevant knowledge, skill and technical elements of the job. SAHPRA
is guided by the principles of Employment Equity. Candidates with disabilities are encouraged
to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill
or not to fill the vacant post/s.

Interested persons who meet the above-stated qualifications should forward their applications
which should consist of a cover letter, detailed Curriculum Vitae, copies of qualification(s) and
Identity Document. ONLY shortlisted candidates will be required to submit certified copies of
qualifications and other related documents on or before the day of the interview following
communication from Human Resources.

SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act
No. 4 of 2013. We will use your personal information provided to us for the purpose of
recruitment only and more specifically for the purpose of the position/vacancy you have
applied for. In the event your application was unsuccessful, SAHPRA will retain your personal
information for internal audit purposes as required by policies.

(APPLICATIONS SENT TO THESE EMAIL ADDRESSES WILL NOT BE CONSIDERED
FOR THE RECRUITMENT PROCESS). The closing date is 17 January 2025 at 16H00.

Manager: Names and Scheduling

MANAGER: NAMES AND SCHEDULING
SALARY: LEVEL 12 (R 1 050 503 – R 1 237 437) per annum (TOTAL COST TO COMPANY)
Ref No.: SAHPRA 037/2024
CENTRE: PRETORIA

REQUIREMENTS: Matric certificate and a Pharmaceutical Master’s Degree at NQF level
9 as recognised by the South African Qualifications Authority (SAQA). Management
qualification will be an added advantage. Proof of current registration with the South
African Pharmacy Council (SAPC).

EXPERIENCE: A minimum of ten (10) years’ relevant experience in the medicines
regulatory field, of which five (5) years must be at a supervisory / management level (Level
09 – 12) supporting business operations. Experience in the application of the Medicines
and Related Substances Control Act 101 of 1965 (as amended), and its related
Regulations. Knowledge of database management will be an added advantage.

COMPETENCIES, KNOWLEDGE, AND SKILLS: Knowledge of and experience with relevant
national legislation, international standards and best practices, e.g. IMDRF, WHO, AMDF,
GHWP. Knowledge of the regulatory environment. Good understanding of committee
evaluation processes. MS Windows, spreadsheet and database application skills. Leadership.
Ability to work in a team. Good planning and organizational skills. Excellent Communication
skills (verbal, written, influencing, conflict management, presentation) and interpersonal skills.
Resilience and ethical behaviour. Communication and stakeholder relationship (internal and
external).

DUTIES: Manage and control the operations, processes, and innovations of the Unit:
Developing and coordinating systems for management of all operations of the Unit. Managing
the development, implementation and maintenance of regulations, guidelines, policies, and
procedures pertaining to naming and scheduling of unregistered and registered medicines,
to ensure alignment with international and national protocols, legislations and other legal
requirements of the Medicines Act. Preparing monthly, quarterly, and annual reports for work
done within the Unit, including monitoring of the timelines. Preparing reports to be submitted
to relevant technical committees for their information, discussion, review and/or
recommendation in accordance with prescribed legal requirements and standard operating
procedures of SAHPRA. Managing general financial budgeting, human resources, and
performance of the Names and Scheduling Unit. Performing such other functions as the
Senior Manager: Clinical Evaluations Management (CEM) may duly allocate or delegate
from time to time. Ensure effectiveness of the Unit operational processes: Developing
operational plans and budget for the Unit. Developing and implementing Annual Performance
plan (APP) for the Unit. Ensure that the unit is aligned with the organizational needs and that
resources are utilized in the most effective and efficient method. Analyzing information and
processes and developing more effective or efficient processes to optimize operations,
processes and strategies. Managing, developing, reviewing, and improving the accuracy of
databases. Managing operations, processes, and projects within the unit. Developing (and
reviewing) internal policies, in collaboration with senior management. Evaluating and
improving security (physical, information, cyber). Risk Management: Identify and manage
risks within the unit. Ensure that critical controls are in place and are effective. Undertake
regular risk mapping exercises within the business unit. Working with the Risk team to
promote an embedded risk culture. Ensure that the business unit is kept up to date with
pending regulatory changes, trends, and best practices and assess the potential impact of
these changes on the business unit’s processes and strategies. Develop business unit
continuity plans that are fit for purpose and ensure unit resilience. Finance and Audit
Management: Reviewing and ensuring submissions of revenue line listings and supporting
evidence are done in line with the Finance Reporting SOP by the 7th of each month to ensure
financial sustainability of the Programme. Ensure that the Programme attains and maintains
an unqualified overall AG Audit outcome on previous year’s performance through
Implementation of internal audit recommendations. Ensure financial sustainability of Names
and Scheduling Unit. Submit annual budget estimates to the senior manager and monthly
review of finance variations for finance reporting. Perform administrative duties as and when
required for the efficient and effective running of the business unit, including capturing of data
into the unit tracker/line listing. Manage and support Names and Scheduling Committee:
Manage the training of external reviewers on SAHPRA templates, policies, and guidelines.
Ensure the correctness of Names and Scheduling Committees recommendations. Oversee
the execution of Names and Scheduling Committees recommendations. Monitor and
evaluate performance of external reviewers.

INSTRUCTIONS TO APPLICANTS: (HOW TO APPLY): Interested applicants who meet the
above requirements should forward their applications accompanied by signed covering letter
attached to the comprehensive CV with the names and email addresses of three (3) referees
clearly reflecting the name of the position and post reference number, and recently certified
copies of ID, required qualification/s (matric included) and driver’s licence where applicable.

• Applications without the aforementioned documents/information will not be considered.
  Should you be in possession of a foreign qualification, it must be accompanied
  by an evaluation certificate from the South African Qualification Authority (SAQA).
• A separate application must be completed for each post. SAHPRA will not be liable
  where applicants use incorrect or no reference number on their applications.
• No late applications will be accepted. CVs will not be returned. Applications, which are
  received after the closing date, will not be considered.
• Further communication will be limited to shortlisted candidates. If you have not received
  a response from SAHPRA within 3 months of the closing date, please consider your
  application as unsuccessful.
• It will be expected of candidates to be available for selection interviews on a date, time
  and place as determined by SAHPRA.

Applicants must note that further checks will be conducted once they are shortlisted and that
their appointment is subject to positive outcomes on these checks, which include security
clearance, qualification verification, criminal records, credit records, citizenship status and
previous employment. All shortlisted candidates will be subjected to a technical exercise
that intends to test relevant knowledge, skill and technical elements of the job. SAHPRA
is guided by the principles of Employment Equity. Candidates with disabilities are encouraged
to apply and an indication in this regard will be appreciated. SAHPRA reserves the right to fill
or not to fill the vacant post/s.

Interested persons who meet the above-stated qualifications should forward their applications
which should consist of a cover letter, detailed Curriculum Vitae, copies of qualification(s) and
Identity Document. ONLY shortlisted candidates will be required to submit certified copies of
qualifications and other related documents on or before the day of the interview following
communication from Human Resources.

SAHPRA comply with the provisions of Protection of Personal Information Act (POPIA); Act
No. 4 of 2013. We will use your personal information provided to us for the purpose of
recruitment only and more specifically for the purpose of the position/vacancy you have
applied for. In the event your application was unsuccessful, SAHPRA will retain your personal
information for internal audit purposes as required by policies.

(APPLICATIONS SENT TO THESE EMAIL ADDRESSES WILL NOT BE CONSIDERED
FOR THE RECRUITMENT PROCESS). The closing date is 17 January 2025 at 16H00.

Technical Specialist (Training & Development)

Job Type: Fixed term

Job Location: Centurion

Closing Date: 15 January 2025 by 16:00

Salary: Competitive – depending on experience.

Minimum Required Qualifications
▪ Grade 12
▪ Three-year bachelor’s degree or Advanced Diploma in Human Resources Management/ Human Resources Development/
Training and Development/ Management of Training/ Public Management/ Public Administration/ Industrial Psychology/
or an equivalent related qualification at NQF level 7 as recognized by SAQA.
▪ SAGE P300 / VIP (or related versions) Payroll and HR system
▪ A valid driver’s licence
▪ Internet; AI; general Technologies awareness

Desirable Qualifications:
▪ A relevant Postgraduate qualification

Minimum Required Experience:
▪ Seven (7) years relevant and extensive work experience in Human Resource Management, especially in Training and
Development and Performance Management and Development System) of which three (3) years must be at supervisory / management level

Desirable Experience:
▪ Previous experience working in a similar role within the NGO sector advantageous

T E C H N I C A L A N D B E H A V I O U R A L C O M P E T E N C I E S
▪ Accountability
▪ Attention to detail
▪ Communication
▪ Dependability and Reliability
▪ Ethics and Integrity
▪ Knowledge of the job
▪ Quality of work and accuracy

THE PRIMARY GOALS:
▪ Investigate, design, and implement training solutions to support SAHPRA’s effectiveness.
▪ Support the organisation to improve regulatory performance through the implementation of targeted training programs in
critical technical areas.
▪ Understand and benchmark the current SAHPRA skills sets by conducting a skills audit utilising the WHO competency
assessment tool.
▪ Based on the outcomes of the audit, develop a capacity development strategy and implementation plan for the next three
(3) years.
▪ Facilitate, and monitor the development of SAHPRA’s competency frameworks.
▪ Identify partners who will support SAHPRA in funding and implementation of the Training Programs.
▪ Continuously monitor the effectiveness of the Training Programs against the SAHPRA Regulatory outputs.
▪ Facilitate leadership development interventions.
▪ Develop and monitor talent management policies, frameworks, processes, and procedures.

IMPROVING THE PERFORMANCE OF THE REGULATORY AUTHORITY
▪ Undertake continuous improvement interventions such as establishment of quality management systems, development of
SOPs for effective implementation of training programs.
▪ Recommends and adheres to budget allocated for training and Training and Development projects.
▪ Establish partnerships with well-established regulatory authorities through the signing of MOUs to formalize relations with
an aim to facilitate training and where relevant collaborative review processes.
▪ Working with a cohort of associates and collaborators that are experts in specific technical areas, create a pool of trainers
and mentors.

HR GOVERNANCE AND REPORTING
▪ Ensure compliance with relevant HR legislation by researching and interpreting HR compliance requirements included in
statutes, policy frameworks and guidelines.
▪ Facilitating the development and monitoring the functioning of Employment Equity and Skills Development Committees,
plans and reporting as legislated.
▪ Management of HR biographic, financial and performance information to ensure it is readily available for HR Audits,
monthly, quarterly, and annual reporting.
▪ Lead and assist on the processes of maintaining records and procedures for to SAHPRA’s training programs.
▪ Development and review of HR Processes and related templates in alignment with approved HR policies

Specialist: Biological Medicine (Vaccine) Clinical Assessor (x3 Positions)

The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory
Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965)
as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection,
registration and control of medicines, scheduled substances, clinical trials and medical devices, and
related matters in the public interest.

This procurement will be managed by Supporting Health Initiatives (SHI), a Division of Wits Health
Consortium Pty Ltd (WHC) for and on behalf of SAHPRA. SHI is dedicated to promoting and enabling
public health activities that lead to new, significant advancements in healthcare and related fields and
does this by providing resources, collaborative opportunities and project management support to
partners and funders. SHI has developed a strong track record of delivering on assignments in Africa.
SHI’s operations and business teams have demonstrated capacity to quickly align with partners,
distribute funds, and oversee implementation.

Specialist: Biological Medicine (Vaccine) Clinical Assessor (3 Positions)
Contract: Ending 31 December 2026, with possible extension based on performance.
Location: Pretoria, South Africa (Hybrid)
Reference: SAHPRA 036/2024
Remuneration: Competitive, depending on experience.

Why Join Us?
This role offers an exceptional opportunity for international experts to contribute to global health by
providing expertise in the evaluation of biological medicines and vaccines. Working in a hybrid
environment, you will collaborate remotely and in person, driving advancements in clinical assessments
and regulatory science in South Africa and beyond.

Key Responsibilities include but are not limited to:

• Strategic Leadership: Provide technical leadership on clinical and non-clinical assessments for
  biological medicines, aligning with local and international regulatory strategies, WHO
  standards, and other National Regulatory Authorities (NRAs).
• Advisory Role: Advise on SAHPRA regulations, policies, and guidelines, ensuring compliance
  with global standards for biological medicines, including vaccines and biotherapeutics.
• Application Evaluation: Conduct detailed assessments of safety and efficacy aspects in
  applications for biological medicines (biotherapeutics, biosimilars, and vaccines) in compliance
  with the Medicines and Related Substances Act (Act No. 101 of 1965).
• Peer Review and Mentorship: Provide critical and analytical feedback as a peer reviewer,
  ensuring thorough evaluation of clinical and non-clinical sections of biological submissions.
  Train and mentor SAHPRA staff to enhance technical capacity.
• Global Collaboration: Represent SAHPRA in international regulatory forums, engage with
  industry stakeholders, and drive innovation in regulatory science.

Performance Expectation include but are not limited to:

• Collaborate effectively with multidisciplinary teams and engage with industry stakeholders on
  regulatory matters.
• Transfer skill to SAHPRA staff and stakeholders on Biological Medicine (Vaccine).
• Maintain resilience, adaptability, and a commitment to excellence in regulatory science.
• Champion innovation in regulatory science to improve the efficiency and effectiveness of
  clinical assessments for biological medicines.
• Adhere to South African data protection laws and SAHPRA’s specific data protection policies

Application Criteria:
Qualifications and Expertise

• Essential:
  o B. Pharm Degree or MBChB with a Master’s in Pharmacy (NQF) Level 09) as evaluated
  by South African Qualifications Authority (SAQA),
  o Registration with professional body
  o A minimum of 10 years of experience in evaluating safety and efficacy for biological
  medicines, including product information and patient information leaflets.
  o Proven knowledge of international guidelines and regulatory standards for clinical
  aspects of biological medicines.

• Preferred:
  o Postgraduate qualifications in virology, vaccinology, or pharmacology of
  biotherapeutics.
  o Expertise in clinical trials, biological dossiers, and regulatory compliance.
  o Experience in hybrid or remote collaboration models.

Core Competencies

• Comprehensive understanding of clinical and non-clinical evaluation for biological medicines.
• Advanced analytical, communication, and decision-making skills for complex regulatory
  challenges.
• Ability to lead and mentor multidisciplinary teams with a focus on knowledge transfer.
• Resilience, adaptability, and a commitment to excellence in regulatory science.

What We Offer

• Hybrid Working Model: Flexibility to work remotely with periodic travel to South Africa,
  supported by advanced technology.
• Global Impact: Contribute to the safety and efficacy of biological medicines worldwide,
  driving public health improvements.
• Professional Growth: Collaborate with global regulatory professionals and gain exposure to
  cutting-edge regulatory practices.
• Collaborative Environment: Be part of a diverse and dynamic team focused on advancing
  public health through regulatory innovation.

Application Process
Submit your application via email to SHIproposals@supportinghi.co.za, by c.o.b 17 January 2025.
Applications must include:

• A detailed cover letter and curriculum vitae.
• Certified copies of qualifications, including professional registrations.
• A copy of a valid driver’s license.

Please note: Applications must clearly state the position and reference number. Late or incomplete
submissions will not be considered.
Diversity and Inclusion: SAHPRA is an equal opportunity employer committed to fostering diversity in
its workforce. Candidates from underrepresented groups and individuals with disabilities are
encouraged to apply.
For inquiries: contact Ms. Setlola Molepo at Setlola.Molepo@sahpra.org.za (Note: Applications sent
to this email will not be processed).
Only shortlisted candidates will be contacted.

Specialist: Biological Medicine (Vaccine) Quality Assessor (x3 positions)

The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory
Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965)
as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection,
registration and control of medicines, scheduled substances, clinical trials and medical devices, and
related matters in the public interest.

This procurement will be managed by Supporting Health Initiatives (SHI), a Division of Wits Health
Consortium Pty Ltd (WHC) for and on behalf of SAHPRA. SHI is dedicated to promoting and enabling
public health activities that lead to new, significant advancements in healthcare and related fields and
does this by providing resources, collaborative opportunities and project management support to
partners and funders. SHI has developed a strong track record of delivering on assignments in Africa.
SHI’s operations and business teams have demonstrated capacity to quickly align with partners,
distribute funds, and oversee implementation.

Specialist: Biological Medicine (Vaccine) Quality Assessor (3 Positions)
Contract: Ending 31 December 2026, with possible extension based on performance.
Location: Pretoria, South Africa (Hybrid)
Reference: SAHPRA 035/2024
Remuneration: Competitive, depending on experience.

Why Join Us?
This role provides an unparalleled opportunity for international experts to bring their specialized skills
to South Africa, working in a hybrid environment that supports both remote and in-country
collaboration. As a Specialist, you will drive the evaluation of biological medicines, contributing to
regulatory excellence and global public health improvements.

Key Responsibilities include but are not limited to:

• Strategic Leadership: Provide technical leadership on local and international regulatory
  strategies for biological medicines, aligned with guidelines from WHO and other National
  Regulatory Authorities (NRAs).
• Advisory Role: Advise on SAHPRA regulations, policies, and guidelines for biological medicines,
  including vaccines and biotherapeutics.
• Application Assessment: Evaluate quality (Chemistry, Manufacturing, and Control – CMC)
  aspects of registration applications for vaccines, biosimilars, and biotherapeutics to ensure
  compliance with relevant legislation and international standards.
• Quality Assurance: Act as a peer reviewer and mentor for quality assessments, ensuring
  thorough and accurate evaluation of biological submissions.
• Capacity Building: Lead training and mentoring initiatives to enhance technical expertise within
  SAHPRA.
• Global Collaboration: Liaise with industry stakeholders and international regulatory bodies to
  advance regulatory best practices.

Performance Expectation include but are not limited to:

• Demonstrate strong analytical, leadership, and problem-solving skills to address complex
  regulatory challenges.
• Develop and implement strategies to ensure SAHPRA’s quality assessment of biological
  medicines adheres to the highest ethical and scientific standards.
• Consistently deliver high-quality, evidence-based quality assessments that meet deadlines
  and contribute to well-informed regulatory decisions.
• Develop and deliver training programs that effectively transfer knowledge and skills to
  colleagues, fostering a strong team of Biological product quality assessors within SAHPRA.
• Be an effective mentor and team player with excellent collaboration and communication
  skills.
• Maintain strong organizational skills and resilience in a fast-paced environment.
• Adhere to South African data protection laws and SAHPRA’s specific data protection policies

Application Criteria:
Qualifications and Expertise

• Essential:
  o B. Pharm Degree with a Master’s in Pharmacology (NQF) Level 09) as evaluated by
  South African Qualifications Authority (SAQA), or a PhD in Biomedical Sciences or a
  related qualification (NQF Level 10)
  o Registration with the professional bodies
  o A minimum of 10 years of experience in compiling and/or reviewing quality aspects
  of biotherapeutic or vaccine Common Technical Document (CTD) dossiers.
  o Strong knowledge of international guidelines and regulatory standards for biological
  medicines.

• Preferred:
  o Postgraduate qualifications in biotherapeutics/vaccine development, pharmaceutics,
  or the regulation of biological medicines.
  o Experience in hybrid or remote collaborative work environments.

Core Competencies

• Extensive knowledge of (Chemistry, Manufacturing, and Control – CMC) aspects for biological
  medicines and international regulatory guidelines.
• Advanced analytical, leadership, and problem-solving skills to address complex regulatory
  challenges.
• Proven ability to mentor and collaborate with multidisciplinary teams.
• Strong organizational skills and resilience in high-pressure environments.

What We Offer

• Hybrid Working Model: Flexibility to work remotely with periodic travel to South Africa,
  supported by advanced digital tools.
• Global Impact: Contribute to shaping regulatory frameworks and advancing the quality of
  biological medicines worldwide.
• Professional Growth: Engage with a network of leading international regulatory experts.
• Collaborative Environment: Join a diverse, innovative team driving transformative public
  health outcomes.

Application Process
Submit your application via email to SHIproposals@supportinghi.co.za, by c.o.b 17 January 2025.
Applications must include:

• A detailed cover letter and curriculum vitae.
• Certified copies of qualifications, including professional registrations.
• A copy of a valid driver’s license.
  Please note: Applications must clearly state the position and reference number. Late or incomplete
  submissions will not be considered.
  Diversity and Inclusion: SAHPRA is an equal opportunity employer committed to fostering diversity in
  its workforce. Candidates from underrepresented groups and individuals with disabilities are
  encouraged to apply

Specialist: Pharmacovigilance

The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory
Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965)
as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection,
registration and control of medicines, scheduled substances, clinical trials and medical devices, and
related matters in the public interest.

This procurement will be managed by Supporting Health Initiatives (SHI), a Division of Wits Health
Consortium Pty Ltd (WHC) for and on behalf of SAHPRA. SHI is dedicated to promoting and enabling
public health activities that lead to new, significant advancements in healthcare and related fields and
does this by providing resources, collaborative opportunities and project management support to
partners and funders. SHI has developed a strong track record of delivering on assignments in Africa.
SHI’s operations and business teams have demonstrated capacity to quickly align with partners,
distribute funds, and oversee implementation.

Specialist: Specialist Pharmacovigilance
Contract: Ending 31 December 2026, with possible extension based on performance.
Location: Pretoria, South Africa (Hybrid)
Reference: SAHPRA 034/2024
Remuneration: Competitive, depending on experience.

Why Join Us?
This role offers a unique opportunity for international subject matter experts to collaborate with
SAHPRA in a hybrid working environment, contributing to pharmacovigilance excellence in South Africa
and globally. As a specialist, you will play a critical role in advancing safety standards for health products,
driving strategic initiatives, and shaping global best practices

Key Responsibilities include but are not limited to:

• Strategic Leadership: Provide technical leadership on pharmacovigilance (PV) strategies
  informed by local and international reports, interventions, and guidelines from the WHO and
  other National Regulatory Authorities (NRAs).
• Regulatory Decision-Making: Make or recommend regulatory decisions on vaccines and
  biological products based on comprehensive reviews and assessments.
• Signal Detection and Investigation: Conduct signal detection, investigate adverse events, and
  analyse safety data from diverse sources to support informed decision-making.
• Capacity Building: Lead training and development initiatives to enhance pharmacovigilance
  expertise among SAHPRA staff and stakeholders.
• Global Collaboration: Represent SAHPRA in international forums and collaborate with global
  regulatory bodies to advance pharmacovigilance frameworks and practices.

Performance Expectation include but are not limited to:

• Foster a culture of pharmacovigilance awareness within the organization.
• Create and maintain effective pharmacovigilance systems and processes that ensure the
  timely detection, assessment, understanding, and prevention of adverse drug reactions .
• Timely submission of required safety reports to regulatory authorities and other relevant
  stakeholders.
• Develop and deliver training programs that enhance the knowledge and skills of staff,
  fostering a culture of pharmacovigilance excellence.
• Utilize advanced signal detection methodologies to proactively identify emerging safety
  issues.
• Contribute to a robust peer review process that identifies potential safety and efficacy
  concerns in a timely manner.
• Consistently deliver high-quality, evidence-based clinical assessments that meet deadlines
  and contribute to well-informed regulatory decisions.
• Collaborate effectively with multidisciplinary teams on PV-related projects.
• Strong analytical and communication skills to interpret safety data and communicate complex
  information effectively.
• Lead and mentor teams in a dynamic regulatory environment.
• Manage multiple priorities and deadlines efficiently with strong organizational skills.
• Proactively identify areas for improvement within SAHPRA’s PV system.
• Conduct thorough reviews and assessments of vaccines and biological products.
• Make informed regulatory decisions on these products based on safety data analysis.
• Provide sound recommendations to support the decision-making process.
• Adhere to South African data protection laws and SAHPRA’s specific data protection policies

Application Criteria:
Qualifications and Expertise

• Essential:
  o MBChB degree with a Master’s in Public Health or Clinical Pharmacology (NQF) Level
  09) as evaluated by South African Qualifications Authority (SAQA), with
  o Registration with the professional bodies.
  o At least 10 years of experience in public health programs or clinical research.
  o Active participation in regional or international regulatory associations or advisory
  bodies
• Preferred:
  o A PhD in public health or pharmacology.
  o Experience in hybrid or remote collaborative work environments

Core Competencies

• Comprehensive knowledge of pharmacovigilance legislation, regulations, and global standards.
• Advanced analytical and communication skills to address complex safety issues innovatively.
• Ability to mentor and lead multidisciplinary teams in dynamic regulatory environments.
• Strong organizational skills and the ability to manage multiple priorities effectively.

What We Offer

• Hybrid Working Model: Flexibility to work remotely with periodic travel to South Africa,
  supported by cutting-edge digital tools.
• Global Impact: Collaborate on projects that advance pharmacovigilance standards and public
  health globally.
• Professional Growth: Engage with leading experts in pharmacovigilance and regulatory science.
• Collaborative Environment: Be part of a diverse, innovative team committed to improving
  health outcomes worldwide.

Application Process
Submit your application via email to SHIproposals@supportinghi.co.za, by c.o.b 17 January 2025.
Applications must include:

• A detailed cover letter and curriculum vitae.
• Certified copies of qualifications, including professional registrations.
• A copy of a valid driver’s license.
  Please note: Applications must clearly state the position and reference number. Late or incomplete
  submissions will not be considered.
  Diversity and Inclusion: SAHPRA is an equal opportunity employer committed to fostering diversity in
  its workforce. Candidates from underrepresented groups and individuals with disabilities are
  encouraged to apply.
  For inquiries: contact Ms. Bafedile Rakgotho at Bafedile.Rakgotho@sahpra.org.za (Note: Applications
  sent to this email will not be processed).

Only shortlisted candidates will be contacted.

Specialist: Good Manufacturing Practices (GMP)

The South African Health Products Regulatory Authority (SAHPRA), is the National Medicines Regulatory
Authority established in terms of the Medicines and Related Substances Act, 1965, (Act No. 101 of 1965)
as amended, to provide for the monitoring, evaluation, regulation, investigation, inspection,
registration and control of medicines, scheduled substances, clinical trials and medical devices, and
related matters in the public interest.

This procurement will be managed by Supporting Health Initiatives (SHI), a Division of Wits Health
Consortium Pty Ltd (WHC) for and on behalf of SAHPRA. SHI is dedicated to promoting and enabling
public health activities that lead to new, significant advancements in healthcare and related fields and
does this by providing resources, collaborative opportunities and project management support to
partners and funders. SHI has developed a strong track record of delivering on assignments in Africa.
SHI’s operations and business teams have demonstrated capacity to quickly align with partners,
distribute funds, and oversee implementation.

Specialist: Good Manufacturing Practices (GMP)
Contract: Ending 31 December 2026, with possible extension based on performance.
Location: Pretoria, South Africa (Hybrid) (South Africans encouraged to apply).
Reference: SAHPRA 033/2024
Remuneration: Competitive, depending on experience.

Why Join Us?
This is a unique opportunity for international subject matter experts to work in a hybrid model,
collaborating with SAHPRA to advance Good Manufacturing Practices (GMP) within South Africa and
beyond. This position offers an unparalleled chance to make a global impact, work alongside leading
professionals, and contribute to the regulatory excellence that safeguards public health worldwide.

Key Responsibilities include but are not limited to:

• Conduct GMP Inspections: Lead local and international pharmaceutical manufacturing site
  inspections, ensuring compliance with GMP standards adopted by SAHPRA.
• Policy Development and Advisory: Shape GMP-related policies, guidelines, and inspection
  frameworks in line with global best practices.
• Global Engagement: Collaborate with international regulatory bodies and represent SAHPRA in
  global regulatory forums and conferences.
• Capacity Building: Provide training, mentorship, and capacity development on GMP regulatory
  practices for SAHPRA staff and stakeholders.
• Risk Management: Ensure ethical, accurate, and efficient management of inspection-related
  risks, resources, and records.

Performance Expectation include but are not limited to:

• Demonstrate strong leadership qualities in a regulatory environment.
• Excellent communication, analytical, and decision-making skills to navigate complex challenges.
• Implement effective risk management strategies to mitigate potential risks and ensure the
  quality and safety of pharmaceutical products.
• Thrive in a dynamic and multicultural environment while working effectively within diverse
  teams.
• Adapt and manage competing priorities efficiently.
• Conduct thorough inspections of local and international pharmaceutical manufacturing sites
• to verify adherence to SAHPRA’s GMP standards.
• Consistently identify and document GMP deviations and compliance issues, and issue
  inspection reports that are accurate, timely, and well-supported by evidence.
• Play a key role in developing and implementing GMP-related policies, guidelines, and
  inspection frameworks.
• Transfer skill to SAHPRA staff and stakeholders on GMP regulations and inspection
  procedures.
• Contribute to capacity development initiatives to enhance GMP expertise within the
  organization.
• Adhere to South African data protection laws and SAHPRA’s specific data protection policies

Application Criteria:
Qualifications and Expertise

• Essential:
  o Master’s degree in Pharmacy.
  o Registration as a Pharmacist.
  o A minimum of 10 years of experience in pharmaceutical manufacturing or quality
  management systems (QMS), including GMP inspections.
  o Proven technical leadership in regulatory environments and participation in
  international regulatory forums or advisory bodies.
• Preferred:
  o A PhD in a related field.
  o Demonstrated experience with hybrid or remote international collaboration.
  Core Competencies
• Deep knowledge of GMP legislation, regulations, and international protocols.
• Advanced analytical, communication, and decision-making skills for complex regulatory
  challenges.
• Proven ability to lead, mentor, and work within diverse teams in high-pressure environments.
• Adaptability and resilience to manage competing priorities effectively.

What We Offer

• Hybrid Working Model: Flexibility to work remotely with periodic travel to South Africa,
  supported by robust digital tools.
• Global Impact: Contribute to shaping GMP standards and advancing public health on a global
  scale.
• Professional Growth: Collaborate with leading regulatory professionals and institutions in a
  dynamic, multicultural environment.
• Innovative Collaboration: Join a team committed to regulatory excellence and transformative
  public health initiatives.

Application Process
Submit your application via email to SHIproposals@supportinghi.co.za, by c.o.b 17 January 2025.
Applications must include:

• A detailed cover letter and curriculum vitae.
• Certified copies of qualifications, including professional registrations.
• A copy of a valid driver’s license.
  Please note: Applications must clearly state the position and reference number. Late or incomplete
  submissions will not be considered.
  Diversity and Inclusion: SAHPRA is an equal opportunity employer committed to fostering diversity in
  its workforce. Candidates from underrepresented groups and individuals with disabilities are
  encouraged to apply.
  For inquiries: contact Mr Itumeleng Mosenyi at Itumeleng. Mosenyi@sahpra.org.za. (Note:
  Applications sent to this email will not be processed).
  Only shortlisted candidates will be contacted.

Click here to apply

We wish you all the best with your applications