Regulatory Affairs Scientist: SAHPRA Submissions & Dossier Lead

Pharma Dynamics (Pty) Ltd.; South Africa; On-site; ZAR 600 000 - 800 000; Full time

Job summary

A leading pharmaceutical company in South Africa is seeking a Regulatory Affairs Manager to oversee regulatory activities, manage change control processes, and liaise with SAHPRA. The ideal candidate will have experience in regulatory submissions and knowledge of SAHPRA guidelines. Responsibilities include conducting due diligence on documentation, compiling responses to SAHPRA recommendations, and maintaining departmental workflows and online applications. This role offers an opportunity to work in a dynamic environment focusing on product lifecycle management.

Qualifications

• Experience with regulatory submissions and compliance processes.
• Strong understanding of SAHPRA guidelines.
• Ability to manage and monitor change control processes.

Responsibilities

• Conduct due diligence on change controls and dossiers for product registration.
• Compile and submit responses to SAHPRA recommendations.
• Liaise with SAHPRA regarding queries on products.

Job description

A leading pharmaceutical company in South Africa is seeking a Regulatory Affairs Manager to oversee regulatory activities, manage change control processes, and liaise with SAHPRA. The ideal candidate will have experience in regulatory submissions and knowledge of SAHPRA guidelines. Responsibilities include conducting due diligence on documentation, compiling responses to SAHPRA recommendations, and maintaining departmental workflows and online applications. This role offers an opportunity to work in a dynamic environment focusing on product lifecycle management.