Senior Regulatory Affairs Scientist

About the role

The Senior Regulatory Affairs Scientist will lead life‑cycle management of products registered with SAHPRA, ensuring timely submission of variations, safety updates and responses to regulatory queries. This role involves close collaboration with internal departments, overseas affiliates and external partners to maintain compliance throughout the product portfolio.

Key responsibilities

• Conduct due‑diligence on change controls, variation packages and dossiers related to product life‑cycle management.
• Prepare and submit responses to SAHPRA recommendations, safety updates and variation applications within defined timelines.
• Compile dossier modules for variations and SAHPRA responses when not provided by third parties.
• Maintain up‑to‑date records of registered products in line with SAHPRA guidelines and priorities.
• Interact regularly with product development, overseas affiliates, contractors and SAHPRA on regulatory matters.
• Manage the applicant interface of SAHPRA applications (Engagement Portal, NDS) and internal online tools (CCP database, DocuBridge).
• Oversee packaging artwork approval and ensure printed components meet SAHPRA requirements.
• Supervise, coach and manage staff as required.
• Monitor the Change Control Process and support internal audits.
• Ensure document management systems (DocuBridge, CCP database) are current and aligned with submitted dossiers.

Required profile

• Senior‑level professional with extensive experience in regulatory affairs within the South African pharmaceutical sector.
• Proven ability to liaise with SAHPRA and manage product life‑cycle submissions.
• Experience supervising and coaching regulatory staff.
• Strong organizational skills to handle multiple dossiers and regulatory timelines.

Required skills

• DocuBridge document management system.
• CCP database administration.
• SAHPRA Engagement Portal and New Drug Submission (NDS) platform.
• Change Control Process management.
• Packaging artwork review and approval.
• Regulatory dossier preparation and variation filing.