Senior Regulatory Affairs Pharmacist

Johannesburg, South AfricaFull-timeSeniorOn-sitePosted 11 Nov 2026

Job Overview

Hire Resolve is recruiting on behalf of Austell Pharmaceuticals for an experienced Senior Regulatory Affairs Pharmacist to join its Regulatory Affairs team in Johannesburg.

The role leads regulatory activities across the product portfolio, ensures ongoing compliance with South African regulatory requirements, manages product lifecycle activities and provides technical leadership to the Regulatory Affairs team, supporting business growth through sound regulatory decision-making and strong SAHPRA and stakeholder engagement.

Key Responsibilities

• Lead regulatory compliance activities in accordance with SAHPRA legislation and pharmaceutical regulations

• Independently compile, review and submit CTD/eCTD dossiers for registrations, renewals, variations and transfers

• Coordinate responses to SAHPRA queries and manage submissions within timelines

• Manage product lifecycle including PI/PIL updates, labelling changes and approved variations

• Review promotional materials, artwork and packaging for regulatory compliance

• Partner with Marketing, Manufacturing, Supply Chain and New Business Development

• Mentor and provide technical guidance to Regulatory Affairs team members

• Drive continuous improvement of regulatory systems, processes and submission tracking

• Build and maintain working relationships with SAHPRA and regulatory stakeholders

Required Qualifications

• B.Pharm degree

• Current SAPC registration

• Minimum 5 years' Regulatory Affairs experience in the pharmaceutical industry

• Experience mentoring or leading Regulatory Affairs team members or projects

• Strong CTD/eCTD submission and dossier compilation experience

• DocuBridge/eCTD or similar regulatory document management systems; existing SAHPRA relationships advantageous

Skills & Requirements

Regulatory AffairsSAHPRACTD/eCTDDossier CompilationDocuBridgeProduct Lifecycle ManagementLabelling CompliancePharmaceutical RegulationsSAPCMentoringStakeholder ManagementAttention to Detail