Regulatory Scientist at Pharma Dynamics (Pty) Ltd

Description

ABLE TO UNDERTAKE ALL OF THE RESPONSIBILITIES BELOW

Product registration

• Conduct due diligence on New Dossier and communicates findings to Lupin or Third-Party Suppliers as required.
• Compile New Dossier and submit in eCTD at agreed timelines
• Liaise with SAHPRA on New Dossiers, SAHPRA queries and variations when required
• Ensure that Site Master Files are submitted to SAHPRA for Overseas Third Party Supplier)
• Conduct due diligence on variations received from Third Party Suppliers or internal requirements
• Compile and submit all responses to SAHPRA queries, Safety Updates and variations, within agreed and specified time limits.
• Maintain the department’s online apps (CCP database, docuBridge, Artwork app) as per official SOPs and/or working instructions.
• Review product artwork and ensures compliance with registration and labelling regulations of Medicines and Related Substances Act 101 of 1965.
• Interact with Lupin and Third-Party Suppliers on dossier related activities (supplier meetings)
• Provide regulatory advice to internal and external stakeholders when required

General

• Perform any other duties as per changes in operational requirements of the department.
• Assist with Product Development and Product Technical Transfer projects.

Requirements
PRE-REQUISITES

• B.Sc. degree or equivalent scientific qualification.
• Minimum of 1-2 years Regulatory hands-on experience, preferably within the pharmaceutical industry.
• Able to perform all standard registration processes under specialist guidance.
• Experience in other areas of pharmaceutical industry such as production and/or analytical environment would be advantageous