Role Overview
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.
Minimum Requirements
Education
- B.Pharm degree
- 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.
Skills & Competencies
- 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.
Apply now and become part of a team committed to delivering quality medicines with conscience.
