Head: Group Regulatory Affairs (midrand)

Key Job Outputs:

Group Regulatory Affairs Strategy

• Develop, and maintain a Group Regulatory Affairs strategy aligned to the Group business strategy, the DMD strategy and business unit commercial plans.
• Translate the strategy into annual regulatory objectives for each business unit aligned to approved business unit regulatory operating plans.
• Define and approve regulatory pathways and submission strategies for new registrations, line extensions, major variations, scheduling changes and new-market entries.
• Lead the Group regulatory strategy for Rest of Africa and export markets, including reliance, abridged and regional collaborative registration pathways.
• Anticipate national, regional and international regulatory change, assess its strategic impact and advise the business on mitigating risk.
• Provide regulatory input into business development, in-licensing, acquisitions, mergers, divestments and technical transfers, and sign off regulatory due diligence.

Regulatory Product Portfolio Management:

• Establish and maintain a single Group view of the registered and pipeline product portfolio across all business units and markets.
• Govern and oversee an integrated Group regulatory pipeline and submission plan, prioritised with Business Development and Marketing on commercial value, regulatory risk and resource capacity.
• Govern and oversee lifecycle management (renewals, post-registration commitments, PI/PIL updates) and drive portfolio rationalisation, including cancellation of dormant or non-viable registrations.
• Maintain control of the dossier room (registration certificates, ceded dossiers, old medicines and CAMs) and approve the Applicant Master File and product lists.
• Track and report portfolio performance (approvals against plan, time to approval, backlog, on-time renewals, dossier compliance)

Functional Leadership of Business Unit Regulatory Affairs:

• Provide functional leadership to the Business Unit Heads of Regulatory Affairs, setting standards, priorities and performance expectations for regulatory operations.
• Establish harmonised Group Regulatory Affairs policies, SOPs, templates, submission quality standards and review/approval workflows.
• Hold monthly functional reviews with each Business Unit Head of Regulatory Affairs.
• Resolve cross-business-unit regulatory priority conflicts and promote the sharing of expertise, resources and best practice.

Regulatory Compliance and Authority Engagement:

• Ensure compliance with SAHPRA license and SAPC requirements, and oversee license applications, amendments, renewals and variations.
• Ensure compliance in all export markets and jurisdictions where Adcock Ingram products are supplied.
• Serve as the primary pharmaceutical and regulatory liaison with SAHPRA, SAPC, international regulatory authorities and industry associations, retaining personal involvement in all critical and strategic interactions.
• Ensure timely and appropriate responses to regulatory observations, inspection findings and deficiencies.
• Ensure product complaints are investigated and managed, and that recalls and withdrawals follow correct procedure, taking the final recall decision with SAHPRA in consultation with QA and Executive Management.

Pharmaceutical Governance (Responsible Pharmacist):

• Establish and maintain pharmaceutical governance frameworks and systems across all licensed operations, ensuring continuous compliance with the Pharmacy Act 53 of 1974, the Medicines and Related Substances Act 101 of 1965 and other applicable legislation.
• Maintain an effective system of delegation to Site Responsible Pharmacists and Business Unit Heads of Regulatory Affairs, and ensure delegated statutory responsibilities are effectively discharged through periodic governance reviews.
• Ensure registration of the Responsible Pharmacist and licensing of the company with the authorities, continuous pharmacist supervision of facilities, Deputy RP cover, and contracts with third-party contractors that clearly allocate responsibilities.
• Lead regular reviews on compliance incidents and trends, and escalate significant regulatory and compliance risks to Executive Management.

GMP/GDP Oversight, Product Release and Pharmaceutical Control:

• Ensure compliance with GMP, GDP and GPP across all operations and that critical deviations, investigations, CAPAs and change controls are appropriately managed.
• Ensure governance systems exist for the release of registered products in line with registered specifications, with adequate control of scheduled substances and full batch traceability.
• Ensure audits of third-party contractors confirm operations comply with approved GMP procedures and dossier specifications.
• Stop release or distribution where significant regulatory, compliance or quality risk exists, and make final decisions on pharmaceutical matters affecting product quality and patient safety.

Audit, Inspection and Risk Management:

• Foster a culture of perpetual inspection readiness, lead Group-level preparation for regulatory inspections and act as Group sponsor during major site inspections.
• Oversee periodic compliance audits of business unit Regulatory Affairs operations, including dossier-to-practice alignment, and ensure effective remediation of critical findings.
• Establish and maintain a structured Regulatory Compliance and Regulatory Affairs risk management framework and Group risk registers, using tools such as FMEA, HACCP and Risk Ranking and Filtering.

Regulatory Systems, Information and Intelligence:

• Own the Group regulatory information management (RIM), electronic publishing and regulatory document management systems, ensuring a single, accurate source of registration data.
• Lead regulatory intelligence and drive Group-wide pharmaceutical compliance and regulatory training programmes.

Budget Management:

• Drive the budgeting process for the function within the timelines and framework.
• Manage and control monthly operational expenses.

People Management and Leadership:

• Provide professional leadership to all Site Responsible Pharmacists and functional leadership to business unit Regulatory Affairs teams.
• Lead regulatory capability development, talent and succession planning for the regulatory community across the Group.
• Lead change management for the Regulatory Affairs realignment, ensuring clear roles, decision rights and communication across the Group and business units.
• Set clear performance standards and objectives, coach and develop employees, and champion diversity and inclusion.
• Promote a culture of compliance, quality, ethical conduct and professional accountability, and model the values of the organisation.

Key Interfaces:

• Internal: DMD department heads; Business Unit Heads of Regulatory Affairs and Managing Directors; Business Development, Marketing, Supply Chain, Quality Assurance, manufacturing sites and distribution centres.
• External: SAHPRA, SAPC, Rest of Africa and other export-market authorities, and industry associations.

Core Competencies:

Technical:

• Pharmacy Act and Medicines Act expertise; SAHPRA regulatory compliance.
• Regulatory affairs, product registration, regulatory strategy and pathway selection.
• Regulatory product portfolio and lifecycle management.
• ICH CTD/eCTD and regulatory publishing; Regulatory Information Management (RIM) systems.
• Rest of Africa and regional reliance regulatory pathways.
• Regulatory due diligence for acquisitions and licensing.
• PIC/S GMP and GDP compliance; Pharmaceutical Quality System; batch release governance.
• CAPA, root cause analysis, change control, compliance risk management and data integrity governance.
• Regulatory inspection management; compliance and regulatory metrics, analytics and reporting.

Leadership:

• Strategic Thinking and Business Acumen: Ability to set Group regulatory direction and align regulatory initiatives with long-term business goals.
• Matrix and Functional Leadership: Ability to lead and influence business unit teams without direct line authority, setting standards and holding teams to them.
• Portfolio Prioritisation and Conflict Resolution: Ability to prioritise a multi-business-unit portfolio on commercial value, regulatory risk and capacity, and to resolve competing priorities.
• Decision Making and Ethical Leadership: Sound, timely decisions on product quality, patient safety and compliance matters, including under pressure.
• Stakeholder Management and Influence: Strong communication, influencing and negotiation skills to build relationships with regulators, executives and cross-functional teams.
• Change Management: Ability to lead the Regulatory Affairs realignment and embed new ways of working.
• Problem Solving and Project Management: Aptitude for identifying challenges, developing solutions and delivering complex regulatory projects within specified timelines.

Requirements

Qualifications:

• B. Pharm Degree.
• Current registration with the South African Pharmacy Council (SAPC) and eligibility for appointment as Responsible Pharmacist.
• Post-graduate qualification in Business Science/Management preferred.

Experience:

• A minimum of ten (10) years' experience in the pharmaceutical industry, particularly in Regulatory Affairs and Regulatory Compliance, including regulatory strategy and product portfolio/lifecycle management.
• A minimum of six (6) years' experience in the pharmaceutical industry in the role of Responsible Pharmacist.
• A minimum of six (6) years in people or team management, including leading through functional (matrix) reporting lines across multiple business units or sites.
• Recent experience in Regulatory Affairs, managing multiple regulatory teams and biosimilar product portfolios preferred.
• Sound working knowledge of SAHPRA and SAPC requirements, ICH CTD/eCTD, and Rest of Africa and regional reliance registration pathways.
• Experience in manufacturing, Quality Assurance and PIC/S GMP/GDP compliance preferred.
• Exposure to regulatory due diligence for acquisitions, licensing or divestments, and to regulatory information management (RIM) systems, will be advantageous.
• This role requires a high degree of networking and collaboration both within and outside the organisation.