Overview
Deputy Head of Regulatory Affairs & Deputy Pharmacist Jobs in Johannesburg, South Africa at Aspen Pharma Group
Position: Deputy Head of Regulatory Affairs & Deputy Responsible Pharmacist
COMPANY DESCRIPTION
We are a global specialty and branded pharmaceutical company, improving the health of patients across the world through our high quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversi?ed by geography, product and manufacturing capability.
Aspen is a dynamic organization built on entrepreneurial strength and forward-thinking minds. We attract high performing individuals who are passionate about their career and have a desire to exceed expectations. At Aspen, not only do we source for the best talent, but we also provide a host of opportunities for continuous development.
The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands. We have approximately 9 100 employees at 69 established offices in over 50 countries and we improve the health of patients in more than 150 countries through our high quality, affordable medicines.
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
Title: Deputy Head of Regulatory Affairs & Deputy Pharmacist
Company: Aspen Pharma Group
Location: Johannesburg, South Africa
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