Regulatory Affairs - Compliance Officer

The Regulatory Affairs Compliance Officer is responsible for establishing, maintaining, monitoring and continuously improving the organisation's regulatory and pharmacovigilance compliance systems to ensure ongoing compliance with South African Health Products Regulatory Authority (SAHPRA), World Health Organization (WHO), export market National Regulatory Authorities (NRAs), and applicable pharmaceutical and vaccine industry requirements. The position serves as the custodian of regulatory intelligence, regulatory compliance monitoring, pharmacovigilance compliance oversight, artwork management and compliance-related quality system activities. The incumbent is responsible for monitoring changes in global and local regulatory requirements, assessing regulatory impacts on business operations, coordinating implementation activities through Change Controls and CAPAs, and ensuring that regulatory expectations are effectively translated into internal procedures, systems and practices. The role also manages the end-to-end vaccine and pharmaceutical product artwork lifecycle, ensuring that all artwork is developed, reviewed, approved and controlled in accordance with regulatory requirements, quality standards and industry best practices.

• To provide regulatory support of product portfolios
• To provide regulatory oversight and compliance through the establishment and maintenance of appropriate regulatory compliance systems as defined by local and legal frameworks for SAHPRA, WHO pre-qualification and export markets
• Maintenance of assigned regulatory information systems
• Ensures compliance in accordance with (Medicines and Related Substances Act 101 of 1965, Pharmacy Act 53 of 1974) and the organisations policies, procedures and other applicable laws. · Continuously support and prescribe to cGMP and cGVP within Biovac
• Continuously build and support a sound quality assurance culture aligned to cGMP and cGVP within Biovac

Requirements:

Required:

• Bachelor's Degree in Pharmacy, Honours in Life Sciences, Biotechnology, Microbiology, Pharmaceutical Sciences or related scientific discipline.

Experience & industry knowledge:

Required:

• At least 3-5 years’ experience within a pharmaceutical, biological, vaccine or healthcare regulatory environment
• Experience in quality and regulatory compliance within a cGMP facility
• Business and operational planning
• Program and project management

Preferred:

• Working knowledge of Pharmaceutical Manufacturing related legislation
• Experience in aseptic (sterile) manufacturing
• Experience in having faced successfully local and/ or international quality audits
• Experience in general business management within a commercial environment

Business Management

• Shared accountability for achieving the site's tactical plans and mitigation of risks impacting quality, regulatory compliance, pharmacovigilance compliance, operational performance and business continuity
• Identify, evaluate and recommend opportunities for regulatory compliance improvements and process efficiencies across the organisation
• Lead or participate in cross-functional projects related to regulatory compliance, pharmacovigilance compliance, quality systems and continuous improvement initiatives
• Monitor, analyse and report key compliance metrics, operational trends and regulatory performance indicators
• Participate in site management activities aimed at proactively identifying, managing and mitigating compliance risks
• Support business continuity by ensuring regulatory obligations are maintained throughout product lifecycle activities
• Contribute to departmental budgeting, resource planning and cost management related to compliance activities
• Develop and maintain regulatory compliance dashboards, metrics and management reports
• Support strategic initiatives through the assessment of regulatory risks, opportunities and emerging compliance requirements.

Technical Competencies required to perform this aspect of the role:

• Process Development, Improvement and Review
• Regulatory Compliance Management
• Intermediate to Advanced Microsoft Word, Excel, PowerPoint and Project
• KPI and Metric Development
• Technical and Regulatory Report Writing
• Risk Assessment and Mitigation
• Statistical Literacy and Data Interpretation
• Project Coordination
• Coaching and Mentoring of Peers and Staff
• Stakeholder Engagement and Communication

Core Technical Delivery

Regulatory Compliance Management

• Maintain, monitor and continuously improve the regulatory compliance framework and associated procedures
• Ensure ongoing compliance with SAHPRA, WHO, PIC/S, pharmacovigilance requirements and applicable international regulatory standards
• Coordinate regulatory compliance activities across departments to ensure alignment with current regulatory expectations
• Perform compliance gap assessments and drive implementation of corrective actions
• Maintain a comprehensive regulatory compliance register and compliance monitoring programme
• Coordinates the applications for Section 21, Section 36 and PITE.

Pharmacovigilance Compliance Oversight

• Support the maintenance and continuous improvement of the Pharmacovigilance System and associated procedures
• Monitor compliance with pharmacovigilance regulations, guidelines and reporting obligations
• Support internal pharmacovigilance audits, inspections and regulatory readiness activities
• Ensure implementation of pharmacovigilance-related regulatory updates and procedural changes
• Track pharmacovigilance compliance metrics and support management review activities

Regulatory Intelligence Management

• Monitor SAHPRA, WHO, Export mark NRA’s and other applicable regulatory authority communications for emerging requirements and regulatory updates
• Assess new regulatory requirements for business impact and identify regulatory, quality and pharmacovigilance implications
• Communicate regulatory intelligence findings to relevant stakeholders
• Maintain a regulatory intelligence tracking system and ensure timely implementation of actions
• Develop impact assessments and implementation plans for regulatory changes
• Coordinate cross-functional review and implementation of new or revised regulatory requirements.

Change Control and CAPA Coordination

• Initiate, coordinate and track Change Controls relating to regulatory and pharmacovigilance compliance requirements
• Coordinate implementation activities resulting from new or revised regulations and guidelines
• Manage CAPAs arising from compliance gaps, audits, inspections or regulatory assessments
• Ensure effective implementation and closure of compliance-related Change Controls and CAPAs
• Monitor effectiveness of implemented actions and report on compliance status.

Artwork Management

• Manage the end-to-end artwork lifecycle for vaccine and pharmaceutical products
• Coordinate artwork development, compilation, review, approval and implementation processes
• Facilitate cross-functional artwork reviews with Regulatory Affairs, Quality Assurance, Manufacturing, Supply Chain, Pharmacovigilance and Commercial stakeholders
• Ensure artwork content remains compliant with approved registrations, product information and regulatory requirements
• Ensure version control and management of artwork records
• Support implementation of new artwork requirements arising from regulatory changes, safety updates and product lifecycle activities
• Maintain artwork approval systems and artwork compliance metrics.

Audit and Inspection Readiness

• Support regulatory inspections, audits and due diligence assessments
• Coordinate responses to regulatory and compliance observations
• Facilitate closure of audit findings within agreed timelines
• Maintain inspection readiness within areas of responsibility
• Participate in internal audits and periodic compliance assessments.

Compliance Reporting

• Develop and ma