Senior Regulatory Affairs Pharmacist
Full-time
LSV Personnel
Key Responsibilities
- Ensure compliance with SAHPRA legislation, the Medicines and Related Substances Act, the Pharmacy Act and applicable regulatory guidelines.
- Maintain awareness of regulatory changes and communicate their business impact.
- Build and maintain effective working relationships with SAHPRA and other regulatory authorities.
- Provide regulatory guidance to internal stakeholders to ensure ongoing compliance.
- Independently compile, review and submit CTD/eCTD dossiers for new registrations, variations, renewals, transfers of ownership and other regulatory applications.
- Compile and review supporting scientific and administrative documentation to ensure high-quality submissions.
- Coordinate and prepare responses to SAHPRA queries and deficiency letters within agreed timelines.
- Manage the lifecycle of assigned products, including PI/PIL updates, labelling changes and implementation of approved variations.
- Maintain accurate regulatory records, document management systems and submission trackers.
- Provide regulatory support for new product launches and lifecycle activities.
- Review and approve promotional and marketing materials to ensure compliance with regulatory requirements and approved product information.
- Review artwork, labels, PI/PILs and packaging components for regulatory compliance.
- Partner with Marketing, Supply Chain, Manufacturing and New Business Development on regulatory matters.
- Support regulatory due diligence for new business opportunities where required.
- Provide day-to-day guidance, mentoring and technical support to Regulatory Affairs team members.
- Support workload planning, prioritisation and achievement of departmental objectives.
- Promote collaboration, knowledge sharing and continuous improvement within the team.
- Monitor submission timelines and portfolio priorities.
- Identify opportunities to improve regulatory processes, systems and digital tools.
- Support implementation of automation and process improvements.
Vacancy posted a month ago
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