Head Group Regulatory Affairs

Afrizan Personnel; Gauteng; On-site; ZAR 1,200,000 - 1,800,000; Full time

Job summary

Afrizan Personnel is recruiting on behalf of a client for an experienced Head: Group Regulatory Affairs in Gauteng, South Africa. You will lead regulatory strategy, portfolio governance, and ensure compliance across SAHPRA and SAPC requirements as the Responsible Pharmacist.

The role involves directing regulatory affairs across groups, engaging with authorities, and driving a culture of quality and continuous compliance. A strong leadership and governance mindset is essential.

Qualifications

• BPharm degree registered with SAPC and eligible to be appointed as Responsible Pharmacist.

Responsibilities

• Develop and implement the Group Regulatory Affairs strategy and governance.
• Oversee registered product portfolio, regulatory pipeline, registrations, renewals and lifecycle management.
• Ensure compliance with SAHPRA, SAPC, GMP/GDP/GPP and applicable legislation.
• Act as liaison with local and international regulatory authorities.
• Provide leadership to Unit Heads of Regulatory Affairs and Site Responsible Pharmacists.
• Oversee governance, product release, audits, recalls and risk management.
• Drive regulatory intelligence, budgeting, and talent development.

Skills

Regulatory strategy

Leadership

Stakeholder engagement

Regulatory compliance

Education

BPharm degree

Postgraduate in Business or Management

Job description

We are recruiting on behalf of a client for an experiencedHead: Group Regulatory Affairs to lead Group regulatory strategy, product portfolio management, pharmaceutical governance and regulatory compliance. The successful candidate will serve as the Responsible Pharmacist, providing strategic direction, engaging with regulatory authorities and driving a culture of quality, accountability and continuous compliance.

Responsibilities:

• Develop and implement the Group Regulatory Affairs strategy, aligned with business objectives and commercial priorities.
• Oversee the registered product portfolio, regulatory pipeline, product registrations, renewals and lifecycle management.
• Ensure compliance with SAHPRA, SAPC, applicable pharmaceutical legislation and GMP, GDP and GPP requirements.
• Act as the primary liaison with local and international regulatory authorities, managing critical regulatory matters, inspections and compliance risks.
• Provide functional leadership to Business Unit Heads of Regulatory Affairs and Site Responsible Pharmacists.
• Oversee pharmaceutical governance, product release, audits, recalls and regulatory risk management to protect product quality and patient safety.
• Drive regulatory intelligence, systems management, budgeting, talent development and succession planning.

Requirements:

• BPharm degree and current registration with the South African Pharmacy Council (SAPC), with eligibility for appointment as Responsible Pharmacist.
• At least 10 years’ pharmaceutical industry experience in Regulatory Affairs and Regulatory Compliance.
• A minimum of six years’ experience as a Responsible Pharmacist within the pharmaceutical industry.
• At least five years’ experience in people or team management, including functional leadership across multiple business units or sites.
• Sound knowledge of SAHPRA and SAPC requirements, ICH CTD/eCTD and Rest of Africa regulatory pathways.
• Strong expertise in regulatory strategy, product registration, portfolio management, pharmaceutical governance and compliance risk management.
• Excellent strategic thinking, business acumen, stakeholder engagement, leadership, decision-making and problem-solving skills.
• Postgraduate qualification in Business Science or Management, Quality Assurance experience, PIC/S GMP/GDP compliance and exposure to regulatory due diligence or RIM systems will be advantageous.

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All positions will be filled in accordance with the company's Employment Equity plan. We encourage people with disabilities to apply.

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