Regulatory Scientist

5 months ago


Western Cape, South Africa Pharma Dynamics (Pty) Ltd. Full time

**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.

**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


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