Regulatory Affairs Pharmacist - Dossier & Compliance

Pharma Dynamics (Pty) Ltd.; Cape Town; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A leading pharmaceutical company in Cape Town is seeking a candidate to manage product and dossier life cycles, interact with regulatory bodies, and assist in compliance activities. Key responsibilities include ensuring timely submissions to SAHPRA and maintaining regulatory documentation. Ideal candidates should have relevant experience in regulatory processes and an ability to work with diverse stakeholders.

Qualifications

• Experience in product/dossier life cycle management.
• Knowledge of regulatory requirements and guidelines, particularly SAHPRA.
• Ability to liaise with various stakeholders, including regulatory bodies.

Responsibilities

• Conduct due diligence on change controls, variation packages, and dossiers.
• Compile and submit responses to regulatory updates within deadlines.
• Review and sign off submissions compiled by Regulatory Scientists.
• Maintain updates on registered products per guidelines.
• Manage the Change Control Process effectively.

Job description

A leading pharmaceutical company in Cape Town is seeking a candidate to manage product and dossier life cycles, interact with regulatory bodies, and assist in compliance activities. Key responsibilities include ensuring timely submissions to SAHPRA and maintaining regulatory documentation. Ideal candidates should have relevant experience in regulatory processes and an ability to work with diverse stakeholders.