Job title : Regulatory Scientist
Job Location : Western Cape, Cape Town
Deadline : September 22, 2024
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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
How to Apply for this Offer
Interested and Qualified candidates should Click here to Apply Now
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