SENIOR REGULATORY AFFAIRS PHARMACIST

Austell; Johannesburg; On-site; ZAR 800,000 - 1,400,000; Full time

Job summary

Austell Pharmaceuticals is seeking an experienced Senior Regulatory Affairs Pharmacist to join our Regulatory Affairs team. This role leads regulatory activities across our portfolio, ensuring ongoing SA regulatory compliance and lifecycle management. You will mentor the regulatory team and engage stakeholders to support business growth.

The ideal candidate has strong CTD/eCTD experience, excellent regulatory knowledge, and a collaborative mindset to drive continuous improvement.

Qualifications

• Qualified pharmacist with SAPC registration.
• Proven track record in regulatory submissions and dossier work.
• Experience leading regulatory affairs teams or projects.

Responsibilities

• Lead regulatory activities across the product portfolio in SA.
• Compile, review and submit CTD/eCTD dossiers for registrations and renewals.
• Coordinate SAHPRA interactions and manage regulatory timelines.

Skills

Leadership

Regulatory Affairs

CTD/eCTD submissions

Stakeholder management

Analytical thinking

Attention to detail

Mentoring

Education

SAPC registration

Tools

DocuBridge/eCTD

Job description

Austell Pharmaceuticals is seeking an experienced Senior Regulatory Affairs Pharmacist to join our Regulatory Affairs team. This role is responsible for leading regulatory activities across our product portfolio, ensuring ongoing compliance with South African regulatory requirements, managing product lifecycle activities, and providing technical leadership to the Regulatory Affairs team. You will play a key role in supporting business growth through sound regulatory decision-making and strong stakeholder engagement.

Key Responsibilities

• Lead regulatory compliance activities in accordance with SAHPRA legislation and applicable pharmaceutical regulations.
• Independently compile, review and submit CTD/eCTD dossiers for new registrations, renewals, variations and transfers.
• Coordinate responses to SAHPRA queries and manage regulatory submissions within required timelines.
• Manage the lifecycle of assigned products, including PI/PIL updates, labelling changes and approved variations.
• Review promotional materials, artwork and packaging to ensure regulatory compliance.
• Partner with Marketing, Manufacturing, Supply Chain and New Business Development on regulatory matters.
• Mentor and provide technical guidance to Regulatory Affairs team members.
• Drive continuous improvement of regulatory systems, processes and submission tracking.
• Build and maintain proven working relationships with SAHPRA and relevant regulatory stakeholders.

Education

• Current SAPC registration

Experience

• Minimum 5 years' Regulatory Affairs experience within the pharmaceutical industry
• Demonstrated experience mentoring or leading Regulatory Affairs team members or projects
• Strong experience with CTD/eCTD submissions and regulatory dossier compilation
• Experience with DocuBridge/eCTD or similar regulatory document management systems
• Proven ability to manage regulatory authority interactions independently
• Existing proven relationships with SAHPRA will be highly advantageous.
• Strong technical regulatory expertise
• Excellent planning and organisational skills
• Strong communication and stakeholder management
• Analytical thinking and sound judgement
• High attention to detail
• Leadership and mentoring capability
• Collaborative mindset with a passion for continuous improvement.