Senior Regulatory Affairs Pharmacist - Lead & Impact

Human Accent; Gauteng; Sur place; ZAR 1 000 000 - 1 500 000; Plein temps

Résumé du poste

Human Accent is seeking a Senior Regulatory Affairs Pharmacist to join our client’s Parktown-based team. You will oversee regulatory activities for registration, maintenance and lifecycle management of the product portfolio, providing technical guidance to the Regulatory Affairs team and liaising with SAHPRA and other stakeholders.

Responsibilities include managing CTD/eCTD submissions, coordinating labeling updates, ensuring compliance with the Medicines Act, mentoring staff, and driving

Qualifications

• B.Pharm degree with current SAHPRA registration.
• Minimum 5 years' Regulatory Affairs experience in pharma.
• Experience mentoring, coaching or leading Regulatory Affairs team members or projects.
• Sound knowledge of SAHPRA requirements, CTD/eCTD submissions and product lifecycle management.
• Proven ability to compile and submit regulatory dossiers and manage authority interactions.

Responsabilités

• Ensure compliance with SAHPRA legislation and applicable regulatory guidelines.
• Independently compile, review and submit CTD/eCTD dossiers for registrations, variations, renewals and transfers.
• Coordinate and prepare responses to SAHPRA queries and deficiency letters.
• Maintain regulatory records, submission trackers and labeling updates across products.
• Provide regulatory support for new product launches and lifecycle activities.

Connaissances

Regulatory knowledge

Leadership potential

Planning & organisation

Communication

Analytical thinking

Attention to detail

Formation

B.Pharm degree

Outils

DocuBridge/eCTD

Description du poste

Human Accent is seeking a Senior Regulatory Affairs Pharmacist to join our client’s Parktown-based team. You will oversee regulatory activities for registration, maintenance and lifecycle management of the product portfolio, providing technical guidance to the Regulatory Affairs team and liaising with SAHPRA and other stakeholders.

Responsibilities include managing CTD/eCTD submissions, coordinating labeling updates, ensuring compliance with the Medicines Act, mentoring staff, and driving