Senior Regulatory Affairs Pharmacist (JHB)

Mvgrecruitment; Johannesburg; On-site; ZAR 600,000 - 900,000; Full time

Job summary

MVG Recruitment is seeking a Senior Regulatory Affairs Pharmacist to strengthen regulatory leadership within a dynamic pharmaceutical environment in Johannesburg. The role focuses on end-to-end regulatory lifecycle, SAHPRA alignment, and cross-functional collaboration.

You will lead CTD/eCTD submissions, manage labeling and PI/PIL updates, mentor RA colleagues, and drive process improvements with Marketing, Manufacturing, and Supply Chain teams.

Qualifications

• Bachelor of Pharmacy degree and current SAPC registration.
• 5+ years Regulatory Affairs experience.
• Experience guiding RA teams or leading RA projects.
• Strong CTD/eCTD submission and dossier compilation capability.
• Experience with DocuBridge/eCTD or similar systems.
• Ability to independently manage regulatory authority interactions.
• Existing SAHPRA relationships advantageous.

Responsibilities

• Oversee regulatory governance in line with SAHPRA legislation.
• Compile and submit CTD/eCTD dossiers for registrations, renewals, variations and transfers.
• Prepare responses to SAHPRA queries and manage submissions within defined timelines.
• Manage PI/PIL updates, labeling amendments and approved variations.
• Review promotional content, artwork and packaging for regulatory accuracy.
• Work with Marketing, Manufacturing, Supply Chain and New Business teams on regulatory matters.
• Mentor RA colleagues and support technical growth within the department.
• Strengthen regulatory systems, workflows and submission tracking.
• Maintain constructive relationships with SAHPRA and relevant regulatory bodies.

Skills

Regulatory leadership

Cross-functional collaboration

Dossier compilation

CTD/eCTD submission

Team mentorship

Education

Bachelor of Pharmacy degree

Tools

DocuBridge

eCTD software

Job description

Senior Regulatory Affairs Pharmacist

REF: MVG/SRA

A high-impact opportunity for an experienced Regulatory Affairs Pharmacist to step into a role focused on strengthening long-term regulatory leadership within a dynamic pharmaceutical environment.

The ideal candidate brings end‑to‑end regulatory lifecycle expertise, including Compliance, Labelling, dossier compilation, authority engagement and team development.

Role Purpose

Drive regulatory oversight across a broad product portfolio, ensure alignment with SAHPRA requirements, manage lifecycle updates, and provide technical direction to the Regulatory Affairs function while collaborating closely with cross‑functional teams.

Key Responsibilities

• Regulatory Governance: Oversee compliance activities aligned to SAHPRA legislation.
• Dossier Management: Compile and submit CTD/eCTD dossiers for new registrations, renewals, variations and transfers.
• Authority Interaction: Prepare responses to SAHPRA queries and manage submissions within defined timelines.
• Lifecycle Oversight: Manage PI/PIL updates, labelling amendments and approved variations.
• Material Evaluation: Review promotional content, artwork and packaging for regulatory accuracy.
• Cross‑Functional Alignment: Work with Marketing, Manufacturing, Supply Chain and New Business teams on regulatory matters.
• Team Capability Building: Mentor RA colleagues and support technical growth within the department.
• Process Enhancement: Strengthen regulatory systems, workflows and submission tracking.
• Stakeholder Engagement: Maintain constructive relationships with SAHPRA and relevant regulatory bodies.

Minimum Requirements

• Bachelor of Pharmacy degree and current SAPC registration
• At least 5 years’ Regulatory Affairs experience
• Demonstrated experience guiding RA teams or leading RA projects
• Strong CTD/eCTD submission and dossier compilation capability
• Experience with DocuBridge/eCTD or similar systems
• Ability to independently manage regulatory authority interactions
• Existing SAHPRA relationships advantageous

Closing Date: 15 September 2026

Supporting Documents required:

• Comprehensive Word CV
• Copy of Degree
• Copy of SAPC Registration Card