OBJECTIVE OF ROLE
The Deputy Head of Regulatory Affairs & Deputy Responsible Pharmacist provides operational leadership and functional oversight across Regulatory Affairs (RA - IPDM and RA-SADC) and Pharmacovigilance (PV) to support the Head of Regulatory Affairs in delivering Aspen's regulatory, safety and commercial objectives for South Africa and the SADC region. The role ensures the effective implementation of the Regulatory Plan, enabling timely marketing authorisations, variation approvals, compliant new product launches, and robust lifecycle maintenance in alignment with business priorities, alliance-partner requirements, and Health Authority expectations.
The incumbent oversees and manages day-to-day operations of RA and PV, ensuring robust systems, procedures and governance frameworks that uphold compliance with the Medicines and Related Substances Act 101 of 1965, the Pharmacy Act 53 of 1974, SAHPRA and SADC regulatory frameworks, cGxP standards, and global regulatory and pharmacovigilance obligations.
The role provides Regulatory and PV intelligence, risk escalation, audit/inspection readiness, cross-functional leadership, and regulatory contributions to strategic projects.
As a senior leader, the role develops and mentors RA and PV teams, driving operational excellence, cross-functional collaboration, regulatory process optimisation, stakeholder engagement, high-quality reporting and KPI management.
When required, the role assumes the delegated statutory duties of the Deputy Responsible Pharmacist, maintaining legal compliance for the Applicant (Pharmacare Ltd - Woodmead), supporting the Responsible Pharmacist to perform the duties and responsibilities in accordance with provisions of the Pharmacy Act, Act 53 of 1974, as amended and The Medicines and Related Substances Act 101 of 1965, as amended.
KEY RESPONSIBILITIES
Regulatory Affairs Strategy Management and Planning
Responsible for oversight and management of the Regulatory Affairs activities and outputs for medicines in South Africa, SADC region and any other markets where Pharmacare IP is active as well as Alliance partner obligations.
Pharmacovigilance
Responsible for oversight and management of the Pharmacovigilance activities and outputs for medicines in South Africa, SADC region and any other markets where Pharmacare IP is active as well as Alliance partner obligations.
Quality Management Systems
Ensure that the Pharmacare entity's Applicant (MAH) Regulatory and Pharmacovigilance responsibilities regarding products in SA and SADC are fully met through the appropriate utilization of Quality Management Systems (QMS) both internally and externally in compliance with Pharmacare and Aspen Group policies, procedures and the relevant legislation and guidelines.
General
Supports and enables service delivery for the RA-IPDM, RA-SADC and PV Departments:
Leads and Supports the Management team to ensure that Aspen values and leadership standards are communicated and understood at all levels within the team
Builds trust among team members by setting a highly visible example in terms of professional excellence and commitment to demonstrating Aspen values and competencies
Drives and supports the establishment of a team culture that values, recognizes and generates high performance, supports innovation and challenges the status quo
Supports and encourages knowledge sharing between and / or across Regulatory, QA, NPL, NBD, Commercial, Project Management, SA Operations, IT, etc.
Evaluate the flow of projects and workload against established timelines and constantly re-evaluate activities and resource-allocation based on changing requirements.
Monitor operations to ensure compliance with regulatory requirements
Ensure on-going maintenance and enhancements to ensure accurate real time reporting of KPIs
Team Management and Leadership
Operationalizing the human resources management and adequately implementing the available HR tools
Accomplish staff deliverables by communicating job expectations; planning, monitoring, and appraising job outputs; mentoring, coaching, counselling, and disciplining employees; developing, coordinating, and enforcing systems, policies, procedures, and productivity standards
Resource needs are reviewed on an ongoing basis. Skills and performance evaluated according to company and departmental needs and policies.
Allocating talent and determining position needs in terms of competencies and making the best possible use of existing competencies as a link between individual skills, knowledge and behaviour and the organization's objectives
Creating/maintaining a working atmosphere that stimulates and motivates employees by providing structured communication and information channels and initiating team- oriented activities Training and development identified and implemented within scope of company and department objectives
Succession planning and Talent Management
Lead, manage, and mentor the Managers and Teams, including reviewing performance against set KPI's
Managing workload for optimal performance against set KPIs and timelines
Determine priorities and manage resource to ensure the Regulatory Plan is achieved
Facilitate regular team meetings to ensure on time delivery
Assess training and development needs, prepare, manage, and implement training programs whilst minimizing cost and downtime
Promote diversity, equal opportunity and fair treatment
Adhere to Company Health & Safety procedures
Budget
Prepare and maintain budgets for RA-IPDM and PV Departments, ensuring budgets are adhered to, raising any potential deviations to the attention of the Head of Regulatory Affairs as soon as possible
Cross Functional Integration support
Ensures that the Regulatory Management team aligns with a matrix management approach
Communicates company vision and culture
Provides input and feedback on optimal service to the business
Engages, communicates and collaborates with Senior Leadership Team and business units
Negotiate and communicate effectively with all stakeholders
Close cooperation with work streams to support cross-functional management, including knowledge sharing
Reporting and tracking
Ensure the operational activities and requirements of the Regulatory departments are tracked and reported regularly
Analysis and reporting of metrics to ensure relevant standards are maintained and objectives are achieved
Ensure on time reporting and minutes are available for the Head of Regulatory South Africa
Compile periodic progress reports on assigned tasks to provide accurate reporting to Executive management and Third-Party Alliance partners
Continuous Improvement & Risk Manage
Identify process gaps in Regulatory and PV workflows.
Ensure any gaps in processes are identified and closed through cross functional discussions and solutions.
Challenge current ways of working with a view to identifying more effective and efficient processes
Develop and implement process improvement initiatives
Maintain risk registers, anticipate compliance risks, and develop mitigation strategies
Electronic Management Systems
Ensure that all dossier management and maintenance activities are performed in the required electronic systems (e.g. Veeva RIMS, Argus)
Drive the implementation and maintenance of e-systems, ensuring compliance with regulatory and Health Authority requirements
Requirements
EDUCATIONAL REQUIREMENTS
Matric (Grade 12)
Bachelor of Pharmacy degree (or equivalent)
Registration with the South African Pharmacy Council as a practicing Pharmacist
KNOWLEDGE & EXPERIENCE REQUIREMENTS
10 years' experience in a Regulatory Affairs environment (Regulatory Affairs and Pharmacovigilance)
Managerial experience in the Regulatory Affairs environment
Experience within pharmaceutical industry in a production, quality, or clinical environment
Project management experience
Quality Management Experience preferred
Comprehensive understanding of The Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act
Good technical knowledge of Regulatory Affairs, Pharmacovigilance and Quality regulations
Comprehensive knowledge of SAHPRA and SADC Regulatory and PV Requirements
Good understanding of new product launch planning and requirements
Existing and well-developed relationships with key stakeholders in SAHPRA and regulatory bodies
SOFT SKILLS AND COMPETENCY REQUIREMENTS
High level of integrity, ethical values and confidentiality
Make good decisions
Customer focus / service-orientated and outcome based
Initiating action, follow up and time management
Positive, diligent and hard worker
Ability to prioritise and co-ordinate work
Self-motivated
Quality orientation
Stress tolerance and conflict resolution
Problem solving, attention to detail and analytical skill
Contribute special expertise
Ability to decide, action and assess when to execute