Senior Regulatory Affairs Pharmacist
Core
Ensure compliance with SAHPRA legislation and regulatory guidelines for medicines, managing product lifecycle registrations and submissions.
Role type
Senior Regulatory Affairs Pharmacist
Builds
CTD/eCTD dossiers, regulatory submissions, and compliant product information for new registrations and variations
Domain
Healthcare / Pharmaceutical Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory compliance, CTD/eCTD dossier compilation, stakeholder management, document management, process improvement, team mentoring, timeline monitoring, marketing material review
Preferred skills
Knowledge of SAHPRA legislation, experience with automation tools, strategic planning
Technologies
CTD/eCTD systems, document management systems
Responsibilities
Compile and review CTD/eCTD dossiers for new registrations and variations; Coordinate responses to SAHPRA queries and deficiency letters; Review and approve promotional and marketing materials for compliance; Provide day-to-day guidance and mentoring to Regulatory Affairs team members; Monitor submission timelines and portfolio priorities; Partner with Marketing, Supply Chain, and Manufacturing on regulatory matters
