Regulatory Affairs Scientist: Dossier & Submissions Expert

Pharma Dynamics (Pty) Ltd; Wes-Kaap; On-site; ZAR 500 000 - 700 000; Full time

Job summary

A pharmaceutical company in South Africa is seeking a professional to manage product life cycle and liaise with regulatory authorities. Responsibilities include conducting due diligence on change controls, compiling submissions to SAHPRA, and ensuring compliance with packaging regulations. The ideal candidate will exhibit strong organizational and communication skills, and familiarity with compliance processes is essential in this role.

Responsibilities

• Conduct due diligence on received change controls and dossiers.
• Compile responses to SAHPRA recommendations and variations.
• Manage Change Control Process effectively.
• Review and facilitate approval of printed packaging components.
• Ensure docuBridge is current and up to date.

Job description

A pharmaceutical company in South Africa is seeking a professional to manage product life cycle and liaise with regulatory authorities. Responsibilities include conducting due diligence on change controls, compiling submissions to SAHPRA, and ensuring compliance with packaging regulations. The ideal candidate will exhibit strong organizational and communication skills, and familiarity with compliance processes is essential in this role.