Job Title: Senior Regulatory Affairs Pharmacist
Fully office-based
About the Role
Are you a registered pharmacist with a proven track record in regulatory compliance and product lifecycle management? We are looking for a strategic and highly organised Senior Regulatory Affairs Pharmacist. In this role, you will take ownership of our product portfolio's registration, maintenance, and lifecycle management while acting as a key technical guide for our Regulatory Affairs team. If you excel at navigating SAHPRA requirements, driving cross-functional collaboration, and mentoring others, this is the perfect opportunity to make a tangible impact on our business objectives.
What You Will Do
- Dossier & Lifecycle Management: Independently compile, review, and submit high-quality CTD/eCTD dossiers for new registrations, variations, renewals, and transfers. You will also manage PI/PIL updates, labelling changes, and implementation of approved variations.
- SAHPRA Liaison & Compliance: Build and leverage strong, proven relationships with SAHPRA and other regulatory authorities. You will ensure strict compliance with the Medicines and Related Substances Act, Pharmacy Act, and all relevant guidelines.
- Business Partnering: Support exciting new product launches and provide regulatory due diligence for new business opportunities. You will also review and approve promotional materials, marketing collateral, and packaging artwork.
- Leadership & Mentorship: Provide day-to-day technical support, coaching, and workload planning for the Regulatory Affairs team, fostering a culture of knowledge sharing and continuous improvement.
- Operational Excellence: Drive efficiency by monitoring submission timelines, identifying process improvements, and utilizing digital tools.
What You Bring to the Table
- Qualifications: A B.Pharm degree and a current, valid SAPC registration.
- Experience: A minimum of 5 years in Regulatory Affairs within the pharmaceutical industry, coupled with demonstrated experience leading, mentoring, or coaching team members.
- Technical Expertise: Deep knowledge of SAHPRA requirements, product lifecycle management, and proven ability to independently manage CTD/eCTD submissions.
- Systems Knowledge: Hands-on experience with DocuBridge/eCTD or equivalent regulatory document management systems.
- Core Competencies: Excellent planning, analytical thinking, sound judgement, and strong stakeholder management skills.