04/09/2026
Job Title: Senior Regulatory Affairs Pharmacist
Location: Johannesburg
The Senior Regulatory Affairs Pharmacist is responsible for managing and coordinating regulatory activities to ensure the successful registration, maintenance and lifecycle management of company’s product portfolio. The role provides technical guidance to the Regulatory Affairs team, supports business objectives through sound regulatory decision-making, maintains effective relationships with SAHPRA and other stakeholders, and contributes to the continuous improvement of regulatory systems and processes.
Key Responsibilities
· Manage SAHPRA registrations, variations, renewals and lifecycle activities.
· Compile, review and submit CTD/eCTD regulatory dossiers.
· Manage SAHPRA queries, deficiency responses and regulatory timelines.
· Ensure compliance with applicable SAHPRA and pharmaceutical legislation.
· Review PI/PILs, artwork, labelling and promotional materials.
· Provide regulatory support to Marketing, Supply Chain, Manufacturing and Business Development.
· Mentor and provide technical guidance to Regulatory Affairs team members.
· Identify opportunities for process improvement and regulatory efficiency.
Minimum Requirements
· B. Pharm degree and current SAPC registration.
· Minimum 5 years' Regulatory Affairs experience within the pharmaceutical industry.
· Demonstrated experience mentoring, coaching or leading Regulatory Affairs team members or projects.
· Sound knowledge of SAHPRA requirements, CTD/eCTD submissions and product lifecycle management.
· Proven ability to independently compile and submit regulatory dossiers and manage regulatory authority interactions.
· Experience with DocuBridge/eCTD or equivalent regulatory document management systems.
Behavioural Competencies
· Strong technical regulatory knowledge
· Leadership potential and ability to mentor others
· Excellent planning and organisational skills
· Strong communication and stakeholder management
· Analytical thinking and sound judgement
· Accountability and attention to detail
· Collaborative approach and continuous improvement mindset Decision-Making Authority
· Recommend regulatory approaches for submissions and lifecycle activities.
· Prioritise workload within agreed departmental objectives.
· Escalate regulatory risks and compliance issues where appropriate.
· Represent the department during routine interactions with SAHPRA and external partners.
· Utilise existing proven relationships with SAHPRA to support regulatory submissions, communications, and compliance activities.
To Apply, send your CV, Qualifications and latest payslip to [email protected]