Manager: Clinical Post-Registration Evaluations at South African Health Products Regulatory Authority

JOB PURPOSE

• The role of the Manager for Clinical Post-Registration Evaluations is responsible for leading the Business Unit by enforcing compliance, develop and implement regulations, mitigate risks and protect public health among others.

RESPONSIBILITIES:

Operational Management:

• Manage the operations of the Business Unit with regards to the processes, inputs, targets, outputs and resourcing requirements.
• Offer technical advice and support to team members on a range of regulatory issues/requirement.
• Implement SAHPRA policies and procedures to identify and resolve complex issues and inconsistencies and make recommendations on initiatives.
• Lead processes for appeals lodged against regulatory decisions taken by the national regulator.
• Manage the development of regulations, regulatory processes and guidelines within the Business Unit.
• Perform quality assurance of processes and outputs to ensure compliance with legislative and regulatory requirements.
• Apply scientific principles, regulatory requirements, best practices and quality assurance and review applications where applicable.
• Conduct reviews and/or adjudicate peer-reviewed reports and provide technical decisions regarding applications.
• Manage and support Clinical Technical Advisory Committee.
• Responsible to capacitate various operations or work streams of the Business Unit with skilled staff.
• Allocate program or project resources in line with strategic direction.
• Identify and prioritise resources across various initiatives or operations.
• Develop and monitor the implementation of the annual operational plan and Business Unit plans.
• Ensure operations and processes of the Business Unit are aligned to the relevant legal frameworks, prescribed local and international Guidelines.

Stakeholder Management:

• Conduct consultation meetings with representatives from the orthodox medicines industry to advise on administrative and technical issues.
• Respond to external enquiries by industry, Business Units within SAHPRA and other external stakeholders.
• Participate in industry engagements and regulatory forums regionally and internationally (e.g. Zazibona, WHO, ICH Working Groups, IPRP, Continental initiatives).
• Financial Management:
• Develop or support the development of the programme’s budget and manage its implementation.
• Work together with Finance Unit to develop and manage the Business Unit’s annual budget.
• Ensure the effective implementation, management, monitoring of the Business Unit’s budget, and mitigate and report on any variances.
• Prepare and submit accurate financial reports within the required timeframe.
• Ensure revenue information is collated and provided to the Finance office within the required timeframe.
• Manage and ensure effective utilisation of financial resources.

Governance, Risk and Compliance Management:

• Develop, review, update and implement policies related to Standard Operating Procedures and Guidelines.
• Adhere to SCM and PFMA aspects and other SAHPRA policies and procedures.
• Ensure process changes are processed through effective change control processes.
• Apply risk management in processes.
• Manage all relevant internal and external audits by responding to any non-conformances or audit findings that are raised and develop mitigation reports.
• Provide timely and accurate evidence and expert analysis to support the Legal Unit in addressing compliance issues and legal matters.
• Ensure deviations or non-conformances are recorded and responded to.
• Implementation of Quality Management Systems (QMS) Culture.
• Manage the development and continuous monitoring of the QMS in the Business Unit – processes, guidelines in alignment with best practices (i.e., National, Regional, Continental, international).
• Manage the development and review of internal policies, in collaboration with senior management. Ensure compliance with implementation of approved processes.
• Ensure training records on all processes are maintained.
• Compile Business Unit reports as required (monthly reports, internal reports, external reports).
• Identify risks for the Business Unit, develop mitigation plans and oversee the implementation of mitigation plans.
• Ensure readiness for internal and external audits by maintaining accurate records, documentation, and compliance with audit requirements.

People Management:

• Develop (i.e., training, coaching, mentoring) and manage (i.e., recruitment, retaining, onboarding, offboarding, daily operations) of Human Resources within the Business Unit.
• Foster a positive and collaborative team culture.
• Ensure maintenance of confidentiality, high ethical conduct, efficient, effective high-quality performance of staff members.
• Manage workstream, staff members’ compliance with organisational policies and procedures by performing regular performance assessments and implementation of individualized interventions where applicable and escalating further non-compliance to the relevant Senior Manager.
• Lead and oversee the work stream team through task delegation, leave administration and planning, and cultivating a cooperative work atmosphere.
• Workstream staff members' training needs are identified, training programs are planned, and professional development is promoted to advance the workstream team's expertise and ensure retraining is executed where applicable.
• Support and manage development of annual performance reports.
• Peer annual performance report and 360 reports.
• Manage employee relations (Labour relations and wellness matters) within the Business Unit.

REQUIREMENTS

• A Matric or Grade 12 certificate and a four-year Bachelor of Pharmacy degree at NQF Level 8 and current registration with the South African Pharmacy Council, or an MBChB degree and registration as a Medical Officer with the Health Professions Council of South Africa (HPCSA) as recognised by the South African Qualifications Authority (SAQA).
• A post-graduate qualification in health sciences at NQF level 9 will be an added advantage.
• A minimum of ten (10) years’ relevant experience in medicines regulatory field in evaluation/compiling safety, quality and efficacy data, including product information and patient information leaflets. At least five (5) years must have been at a supervisory / management level (Level 09 – 12) supporting business operations.
• Experience in medicine registration will be an added advantage.
• Experience in the application of the Medicines and Related Substances Control Act 101 of 1965 (as amended), and its related Regulations.
• A valid driver’s licence.

COMPETENCIES AND SKILLS

• Knowledge and application of the Medicines and Related Substances Control Act (101 of 1965), as amended, and its related Regulations and Guidelines.
• Knowledge of technical aspects for the evaluation of quality, safety, and efficacy of medicines.
• Knowledge of Regulatory framework, policies, and process. Knowledge and understanding of clinical pharmacology.
• Understanding of medicine registration and harmonised standards.
• Knowledge of Good Clinical Practice.
• Organisational awareness.
• Principles of quality management.
• Performance and team management.
• Critical and analytical thinking.
• Projects management and leadership.
• Ability to manage a variety of cross-functional team members.
• Report writing.
• Communication skills (verbal, written, negotiation, conflict management, presentation).
• Risk based decision and Evidence-informed practice.
• Planning and organising.
• Change management.
• Problem analysis and solving.
• Interpersonal skills and team player.
• Integrity and flexibility.
• Attention to detail and results driven.
• Resilience and ethical behaviour.